A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT02880371
• Recruitment Status: Terminated
• First Posted: August 26, 2016
• Results First Posted: June 16, 2022
• Last Update Posted: June 16, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumors
• Interventions: Drug: ARRY-382; Drug: Pembrolizumab
• Enrollment: 82

Participant Flow

Recruitment Details

This study had 2 phases: Phase 1B and 2. Originally, Phase 1b of the study had Part A and B. Part A was dose escalation in participants with selected advanced solid tumors. Part B was expansion in melanoma participants. Part C was a part of Phase 2, in participants with non-small cell lung cancer (NSCLC).

Pre-assignment Details

There was an amendment in protocol, which removed originally designed Part B and C, due to low enrolment. Post-implementation of this amendment 2, Part B and C were replaced with 3 cohorts in Phase 2. Study then had Part A (Phase 1b), and 3 cohorts in Phase 2. Cohorts of Phase 2 were as follows: 1) PD-1/PD-L1 inhibitor-refractory cohort, 2) pancreatic ductal adenocarcinoma cohort and 3) platinum-resistant ovarian cancer cohort.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 milligrams (mg) orally, once daily (QD) in combination with pembrolizumab at a dose of 2 milligram per kilogram (mg/kg) intravenously (IV) every 3 weeks (Q3W) in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a programmed cell death receptor 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) inhibitor-containing regimen as their most recent prior line of therapy and were new to prior colony-stimulating factor 1 receptor (CSF-1R) or colony-stimulating factor 1(CSF-1) inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior checkpoint inhibitor (CPI) therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Period Title: Phase 1b
Started	6	7	7	1	0	0	0	0
Treated	6	6	7	1	0	0	0	0
Completed	0	0	1	0	0	0	0	0
Not Completed	6	7	6	1	0	0	0	0
Reason Not Completed
Lost to Follow-up	1	0	0	0	0	0	0	0
Participants terminated by Sponsor	1	0	0	0	0	0	0	0
Withdrawal by Subject	0	0	1	0	0	0	0	0
Death	4	6	5	1	0	0	0	0
Enrolled but not Treated	0	1	0	0	0	0	0	0
Period Title: Phase 2
Started	0 [1]	0 [1]	0 [1]	0 [1]	2 [2]	20 [2]	28 [2]	11 [2]
Treated	0	0	0	0	2	19	27	11
Completed	0	0	0	0	0	0	0	0
Not Completed	0	0	0	0	2	20	28	11
Reason Not Completed
Enrolled but not Treated	0	0	0	0	0	1	1	0
Other	0	0	0	0	0	1	2	1
Participants terminated by Sponsor	0	0	0	0	1	6	1	5
Death	0	0	0	0	1	10	20	5
Lost to Follow-up	0	0	0	0	0	0	3	0
Withdrawal by Subject	0	0	0	0	0	1	1	0
End of Study page not completed by error	0	0	0	0	0	1	0	0
[1] Participants of Phase 1b were different from Phase 2.; [2] Participants enrolled for Phase 2 were different from participants enrolled for Phase 1b.

Baseline Characteristics

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort	Total
Arm/Group Description		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Total of all reporting groups
Overall Number of Baseline Participants		6	6	7	1	2	19	27	11	79
Baseline Analysis Population Description		Baseline characteristics were reported for full analysis set (FAS). FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	6 participants	6 participants	7 participants	1 participants	2 participants	19 participants	27 participants	11 participants	79 participants
		63.7 (12.4)	52.2 (16.0)	54.7 (12.9)	68.0 [1] (NA)	47.0 (0.0)	63.1 (12.0)	65.0 (9.6)	59.3 (13.1)	61.6 (12.2)
		[1] Since only 1 evaluable participant, standard deviation could not be calculated.
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	7 participants	1 participants	2 participants	19 participants	27 participants	11 participants	79 participants
	Female	2 33.3%	3 50.0%	4 57.1%	0 0.0%	0 0.0%	12 63.2%	12 44.4%	11 100.0%	44 55.7%
	Male	4 66.7%	3 50.0%	3 42.9%	1 100.0%	2 100.0%	7 36.8%	15 55.6%	0 0.0%	35 44.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	7 participants	1 participants	2 participants	19 participants	27 participants	11 participants	79 participants
	Hispanic or Latino	1 16.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.7%	0 0.0%	2 2.5%
	Not Hispanic or Latino	5 83.3%	6 100.0%	7 100.0%	1 100.0%	2 100.0%	18 94.7%	23 85.2%	10 90.9%	72 91.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.3%	3 11.1%	1 9.1%	5 6.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	7 participants	1 participants	2 participants	19 participants	27 participants	11 participants	79 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	1 1.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 15.8%	2 7.4%	0 0.0%	5 6.3%
	White	5 83.3%	6 100.0%	7 100.0%	1 100.0%	2 100.0%	15 78.9%	23 85.2%	9 81.8%	68 86.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 16.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.3%	2 7.4%	1 9.1%	5 6.3%

Outcome Measures

1. Primary Outcome

Title	Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)
Description	DLT: adverse event (AE) or abnormal laboratory value not clearly attributable to an extraneous cause, such as disease progression, intercurrent illness, or concomitant medications occurring during 21 days of Cycle 1, met 1 of the criteria A) nonhematologic AEs: recurring grade 2 pneumonitis, grade 3 events (irAE, QTcF prolongation, rash; other grade 3/4 except alopecia, nausea, diarrhea, vomiting, tumor flare, pseudoprogression, endocrinopathy); B) hematology AEs/laboratory abnormalities: grade 4 events except lymphopenia, neutropenia, electrolyte imbalances or abnormalities, grade 3 thrombocytopenia, febrile neutropenia, grade 4 AST/ALT elevation, grade 3 AST/ALT elevation lasting >7 days, associated with bilirubin levels>=2*ULN or international normalized ratio >1.5, grade 3 bilirubin elevation >=3, CK elevation >=grade 3 lasting, increase in creatinine >=1.5*baseline value, dose delay (dose interruption for >14 days) or other (inability to receive at least 67% of ARRY-382 doses).
Time Frame	Cycle 1 (up to 21 days)

Outcome Measure Data

Analysis Population Description

Dose-determining set (DDS) included all participants in Phase 1b who received at least 67% of the planned cumulative dose of ARRY-382 during Cycle 1 or discontinued the treatment because of DLT.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 16.7%	2 28.6%

2. Primary Outcome

Title	Phase 2 Cohorts: Objective Response Rate (ORR)
Description	ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
Time Frame	From day of first dose to 30 days after last dose (maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	19	27	11
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	0.0; (0.0 to 17.6)	3.7; (0.1 to 19.0)	0.0; (0.0 to 28.5)

3. Secondary Outcome

Title	Phase 1b, Part A: Objective Response Rate (ORR)
Description	ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator review of radiographic disease assessments per RECIST v1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.
Time Frame	From day of first dose to 30 days after last dose (maximum up to 34.7 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	16.7; (0.4 to 64.1)	16.7; (0.0 to 64.1)	0.0; (0.0 to 41.0)

4. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR)
Description	DOR was defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression, or death due to any cause after achieving a response. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures < 10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. DOR was estimated using the Kaplan-Meier method.
Time Frame	From date of first documented CR or PR up to disease progression or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was evaluated in participants who achieved an objective response. "Overall Number of participants Analyzed" =0, signifies participants did not had documented CR or PR for respective reporting arms.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	1	1	0	0	1	0
Median (95% Confidence Interval); Unit of Measure: months
	29.2 [1]; (NA to NA)	3.1 [2]; (NA to NA)			2.4 [2]; (NA to NA)

[1]

Upper and lower limit of confidence interval (CI) not reached due to less number of participants with events.

[2]

Upper and lower limit of CI not reached due to less number of participants with events.

5. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)
Description	PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST v1.1, or death due to any cause, whichever occurs first. If a participant did not have a PFS event at the time of the analysis cut-off or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Time Frame	From day of first dose until disease progression or death due to any cause or till last tumor assessment date (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Median (95% Confidence Interval); Unit of Measure: months
	4.7; (1.4 to 33.1)	2.3; (1.3 to 5.7)	1.4; (0.5 to 2.6)	1.6; (1.3 to 4.4)	1.4; (0.9 to 2.8)	2.1; (1.2 to 4.1)

6. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)
Description	OS was defined as the time from the start of treatment to the date of death due to any cause. If a death was not observed by the date of the analysis cut-off, OS was censored at the date of last contact. OS was estimated using the Kaplan-Meier method.
Time Frame	From day of first dose till death due to any cause or date of last contact (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Median (95% Confidence Interval); Unit of Measure: months
	14.7 [1]; (5.2 to NA)	7.4; (2.1 to 14.1)	6.5 [1]; (1.0 to NA)	12.4 [1]; (3.6 to NA)	2.2; (1.5 to 4.9)	NA [2]; (5.3 to NA)

[1]

Upper limit of CI not reached due to less number of participants with events.

[2]

Median and upper limit of CI not reached due to less number of participants with events.

7. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR)
Description	irRR was defined as the percentage of participants who achieved immune-related best overall response (irBOR) of immune-related CR (irCR) or immune-related PR (irPR), as determined by the investigator per immune related response criteria (irRC). irBOR was the best response using irRC recorded from the start of study treatment until the end of treatment. irCR was the disappearance of all target lesions, irPR was a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.
Time Frame	From day of first dose till up to end of study treatment (for Phase 1b: maximum up to 33.7 months, for Phase 2: maximum up to 12.5 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	16.7; (0.4 to 64.1)	16.7; (0.4 to 64.1)	0.0; (0.0 to 41.0)	0.0; (0.0 to 17.6)	3.7; (0.1 to 19.0)	0.0; (0.0 to 28.5)

8. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)
Description	irPFS was defined as the time from the start of treatment to the time of first documented progression per irRC, or death due to any cause. irRC criteria for progression for 1) Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%); 2) New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. For the analysis of irPFS, Kaplan-Meier method was used.
Time Frame	From the start of treatment to the time of first documented progression, or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Median (95% Confidence Interval); Unit of Measure: months
	3.0; (1.4 to 16.1)	2.5; (1.4 to 7.1)	1.3; (0.5 to 1.5)	1.5; (1.3 to 4.3)	1.3; (0.9 to 2.7)	2.5 [1]; (1.2 to NA)

[1]

Upper limit of CI not reached due to less number of participants with events.

9. Secondary Outcome

Title	Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation
Description	Tumor markers were measured for tumor type from serum samples obtained from participants in Phase 2. Mean change from baseline was reported in this outcome measure.
Time Frame	Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment discontinuation (before 13.5 months)

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was planned in prOVCA cohort. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

Arm/Group Title		Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		11
Mean (Standard Deviation); Unit of Measure: microgram per milliliter
Cycle 1 Day 1	Number Analyzed	10 participants
		578.6 (626.3302643)
Cycle 1 Day 8	Number Analyzed	11 participants
		803.3181818 (808.9155788)
Cycle 1 Day 15	Number Analyzed	9 participants
		1279.833333 (1298.144638)
Cycle 2 Day 1	Number Analyzed	10 participants
		1485.6 (1368.310653)
Cycle 3 Day 1	Number Analyzed	5 participants
		1558.4 (1502.22728)
Cycle 4 Day 1	Number Analyzed	1 participants
		1980 [1] (NA)
Cycle 5 Day 1	Number Analyzed	1 participants
		778 [1] (NA)
Cycle 6 Day 1	Number Analyzed	1 participants
		1730 [1] (NA)
Cycle 7 Day 1	Number Analyzed	1 participants
		2080 [1] (NA)
Treatment discontinuation	Number Analyzed	6 participants
		1743.833333 (1817.18193)

[1]

Since only 1 evaluable participant, standard deviation could not be calculated.

10. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Measure Type: Count of Participants; Unit of Measure: Participants
AEs	6 100.0%	6 100.0%	6 85.7%	19 100.0%	27 100.0%	10 90.9%
SAEs	3 50.0%	1 16.7%	3 42.9%	8 42.1%	15 55.6%	5 45.5%

11. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03
Description	Abnormalities: Albumin (hypoalbuminemia),Alkaline phosphatase (ALP increased), Alanine aminotransferase (ALT increased), Aspartate aminotransferase (AST increased),Total bilirubin (TBL increased), Creatinine (increased), Corrected calcium (hypocalcemia/hypercalcemia), Creatine kinase (CK increased), Glucose (hypoglycemia/hyperglycemia), Amylase (increased), Lipase (increased) ,Phosphate (hypophosphatemia), Magnesium (hypomagnesemia/hypermagnesemia), Potassium (hypokalemia/hyperkalemia), Sodium (hyponatremia/hypernatremia). Participants with all grades and grade 3/4 abnormalities were reported. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening.
Time Frame	First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Measure Type: Count of Participants; Unit of Measure: Participants
Albumin (grams per liter [g/L]), Hypo: All Grades	4 66.7%	2 33.3%	4 57.1%	5 26.3%	10 37.0%	2 18.2%
Albumin (g/L), Hypo: Grade 3/4	1 16.7%	0 0.0%	1 14.3%	0 0.0%	3 11.1%	0 0.0%
Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades	5 83.3%	3 50.0%	4 57.1%	11 57.9%	17 63.0%	6 54.5%
Alkaline Phosphatase (U/L), Hyper: Grade 3/4	1 16.7%	0 0.0%	0 0.0%	0 0.0%	4 14.8%	0 0.0%
Alanine Aminotransferase (U/L), Hyper: All Grades	2 33.3%	3 50.0%	4 57.1%	8 42.1%	12 44.4%	7 63.6%
Alanine Aminotransferase (U/L), Hyper: Grade 3/4	0 0.0%	1 16.7%	1 14.3%	2 10.5%	1 3.7%	3 27.3%
Amylase (U/L), Hyper: All Grades	3 50.0%	4 66.7%	2 28.6%	11 57.9%	7 25.9%	7 63.6%
Amylase (U/L), Hyper: Grade 3/4	2 33.3%	0 0.0%	0 0.0%	3 15.8%	1 3.7%	1 9.1%
Aspartate Aminotransferase (U/L), Hyper: All Grades	5 83.3%	6 100.0%	6 85.7%	17 89.5%	23 85.2%	11 100.0%
Aspartate Aminotransferase (U/L), Hyper: Grade 3/4	1 16.7%	2 33.3%	2 28.6%	4 21.1%	5 18.5%	2 18.2%
Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades	1 16.7%	0 0.0%	1 14.3%	3 15.8%	7 25.9%	1 9.1%
Bilirubin (umol/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	1 14.3%	0 0.0%	3 11.1%	0 0.0%
Calcium (millimoles per liter [mmol/L]), Hypo: All Grades	1 16.7%	1 16.7%	1 14.3%	1 5.3%	0 0.0%	2 18.2%
Calcium (mmol/L), Hypo: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Calcium (mmol/L), Hyper: All Grades	0 0.0%	0 0.0%	0 0.0%	1 5.3%	1 3.7%	0 0.0%
Calcium (mmol/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Creatine Kinase (U/L), Hyper: All Grades	5 83.3%	5 83.3%	5 71.4%	16 84.2%	20 74.1%	7 63.6%
Creatine Kinase (U/L), Hyper: Grade 3/4	0 0.0%	2 33.3%	1 14.3%	3 15.8%	2 7.4%	2 18.2%
Creatinine (umol/L), Hyper: All Grades	2 33.3%	2 33.3%	1 14.3%	7 36.8%	6 22.2%	2 18.2%
Creatinine (umol/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	0 0.0%
Glucose (mmol/L), Hypo: All Grades	0 0.0%	1 16.7%	0 0.0%	3 15.8%	1 3.7%	0 0.0%
Glucose (mmol/L), Hypo: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	0 0.0%
Glucose (mmol/L), Hyper: All Grades	1 16.7%	1 16.7%	1 14.3%	0 0.0%	0 0.0%	2 18.2%
Glucose (mmol/L), Hyper: Grade 3/4	1 16.7%	1 16.7%	1 14.3%	0 0.0%	0 0.0%	2 18.2%
Potassium (mmol/L), Hypo: All Grades	1 16.7%	2 33.3%	3 42.9%	7 36.8%	6 22.2%	4 36.4%
Potassium (mmol/L), Hypo: Grade 3/4	1 16.7%	0 0.0%	0 0.0%	2 10.5%	1 3.7%	0 0.0%
Potassium (mmol/L), Hyper: All Grades	0 0.0%	0 0.0%	0 0.0%	1 5.3%	4 14.8%	1 9.1%
Potassium (mmol/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Lipase (U/L), Hyper: All Grades	5 83.3%	4 66.7%	3 42.9%	8 42.1%	2 7.4%	5 45.5%
Lipase (U/L), Hyper: Grade 3/4	2 33.3%	2 33.3%	0 0.0%	7 36.8%	0 0.0%	2 18.2%
Magnesium (mmol/L), Hypo: All Grades	0 0.0%	1 16.7%	0 0.0%	5 26.3%	4 14.8%	3 27.3%
Magnesium (mmol/L), Hypo: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Magnesium (mmol/L), Hyper: All Grades	2 33.3%	1 16.7%	2 28.6%	3 15.8%	5 18.5%	0 0.0%
Magnesium (mmol/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Phosphate (mmol/L), Hypo: All Grades	1 16.7%	3 50.0%	0 0.0%	6 31.6%	7 25.9%	2 18.2%
Phosphate (mmol/L), Hypo: Grade 3/4	1 16.7%	0 0.0%	0 0.0%	2 10.5%	2 7.4%	0 0.0%
Sodium (mmol/L), Hypo: All Grades	3 50.0%	2 33.3%	3 42.9%	8 42.1%	13 48.1%	6 54.5%
Sodium (mmol/L), Hypo: Grade 3/4	0 0.0%	0 0.0%	1 14.3%	0 0.0%	5 18.5%	1 9.1%
Sodium (mmol/L), Hyper: All Grades	3 50.0%	0 0.0%	0 0.0%	4 21.1%	0 0.0%	0 0.0%
Sodium (mmol/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

12. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03
Description	Hematology abnormalities: Hemoglobin (anemia/hemoglobin increased), Platelets (count decreased), Leukocytes (count decreased/increased), Neutrophils (count decreased), Lymphocytes (count increased/decreased). Coagulation abnormalities: International Normalized Ratio (INR increased), Partial thromboplastin time(PTT)/Activated partial thromboplastin Time (aPTT, time prolonged). Abnormalities were graded by CTCAE grade 4.03 as Grade 1= mild; Grade 2 = moderate; Grade 3/Grade 4 = severe/life-threatening. Participants with all grades and grade 3/4 abnormalities were reported.
Time Frame	First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Measure Type: Count of Participants; Unit of Measure: Participants
Hemoglobin (g/L), Hypo: All Grades	3 50.0%	4 66.7%	5 71.4%	12 63.2%	9 33.3%	7 63.6%
Hemoglobin (g/L), Hypo: Grade 3/4	1 16.7%	0 0.0%	1 14.3%	4 21.1%	2 7.4%	2 18.2%
Hemoglobin (g/L), Hyper: All Grades	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%
Hemoglobin (g/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Lymphocytes (10^9/L), Hypo: All Grades	2 33.3%	1 16.7%	3 42.9%	11 57.9%	11 40.7%	5 45.5%
Lymphocytes (10^9/L), Hypo: Grade 3/4	2 33.3%	1 16.7%	2 28.6%	5 26.3%	1 3.7%	2 18.2%
Lymphocytes (10^9/L), Hyper: All Grades	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.7%	0 0.0%
Lymphocytes (10^9/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Neutrophils (10^9/L), Hypo: All Grades	1 16.7%	3 50.0%	0 0.0%	1 5.3%	0 0.0%	1 9.1%
Neutrophils (10^9/L), Hypo: Grade 3/4	1 16.7%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	0 0.0%
Platelets (10^9/L), Hypo: All Grades	1 16.7%	1 16.7%	2 28.6%	2 10.5%	2 7.4%	1 9.1%
Platelets (10^9/L), Hypo: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	0 0.0%
Leukocytes (10^9/L), Hypo: All Grades	2 33.3%	1 16.7%	3 42.9%	4 21.1%	2 7.4%	2 18.2%
Leukocytes (10^9/L), Hypo: Grade 3/4	1 16.7%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	0 0.0%
Leukocytes (10^9/L), Hyper: All Grades	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Leukocytes (10^9/L), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Activated Partial Thromboplastin Time (sec), Hyper: All Grades	2 33.3%	2 33.3%	2 28.6%	6 31.6%	7 25.9%	3 27.3%
Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4	0 0.0%	0 0.0%	1 14.3%	2 10.5%	2 7.4%	0 0.0%
Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades	1 16.7%	3 50.0%	2 28.6%	9 47.4%	15 55.6%	3 27.3%
Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4	0 0.0%	0 0.0%	0 0.0%	2 10.5%	1 3.7%	0 0.0%

13. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests
Description	Liver function parameters/abnormalities: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): >3* upper limit of normal (ULN), >5*ULN, >8*ULN, >10*ULN, >20*ULN; Bilirubin >1.5*ULN, >2*ULN; Alkaline phosphatase (ALP) >2*ULN, >3*ULN.
Time Frame	First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Measure Type: Count of Participants; Unit of Measure: Participants
Alanine Aminotransferase: >3*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	2 33.3%	2 33.3%	3 15.8%	2 8.0%	4 36.4%
Alanine Aminotransferase: >5*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	1 16.7%	1 16.7%	2 10.5%	1 4.0%	3 27.3%
Alanine Aminotransferase: >8*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	2 10.5%	1 4.0%	3 27.3%
Alanine Aminotransferase: >10*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	1 5.3%	1 4.0%	3 27.3%
Alanine Aminotransferase: >20*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%
Alkaline Phosphatase: >2*ULN	Number Analyzed	4 participants	6 participants	5 participants	18 participants	21 participants	11 participants
		1 25.0%	3 50.0%	2 40.0%	5 27.8%	12 57.1%	3 27.3%
Alkaline Phosphatase: >3*ULN	Number Analyzed	5 participants	6 participants	5 participants	19 participants	25 participants	11 participants
		1 20.0%	0 0.0%	1 20.0%	4 21.1%	9 36.0%	1 9.1%
Aspartate Aminotransferase: >3*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		2 33.3%	3 50.0%	4 66.7%	7 36.8%	13 52.0%	5 45.5%
Aspartate Aminotransferase: >5*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		1 16.7%	2 33.3%	2 33.3%	4 21.1%	5 20.0%	2 18.2%
Aspartate Aminotransferase: >8*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	1 16.7%	1 16.7%	1 5.3%	1 4.0%	2 18.2%
Aspartate Aminotransferase: >10*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	1 16.7%	1 16.7%	1 5.3%	1 4.0%	2 18.2%
Aspartate Aminotransferase: >20*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	1 9.1%
Bilirubin: >1.5*ULN	Number Analyzed	6 participants	6 participants	5 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 20.0%	1 5.3%	5 20.0%	0 0.0%
Bilirubin: >2*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	1 5.3%	4 16.0%	0 0.0%
ALT or AST: AT >3*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		2 33.3%	3 50.0%	4 66.7%	7 36.8%	13 52.0%	5 45.5%
ALT or AST: AT >5*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		1 16.7%	2 33.3%	2 33.3%	4 21.1%	5 20.0%	3 27.3%
ALT or AST: AT >8*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	1 16.7%	1 16.7%	2 10.5%	1 4.0%	3 27.3%
ALT or AST: AT >10*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	1 16.7%	1 16.7%	1 5.3%	1 4.0%	3 27.3%
ALT or AST: AT >20*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	0 0.0%	1 5.3%	0 0.0%	1 9.1%
ALT or AST and Total Bilirubin >2*ULN: AT >3*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	1 5.3%	4 16.0%	0 0.0%
ALT or AST and Total Bilirubin >2*ULN: AT >5*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	1 5.3%	0 0.0%	0 0.0%
ALT or AST and Total Bilirubin >2*ULN: AT >10*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	1 5.3%	0 0.0%	0 0.0%
ALP >3*ULN and Total Bilirubin >2*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	1 5.3%	3 12.0%	0 0.0%
ALT or AST >3*ULN and ALP <2*ULN and Total Bilirubin >2*ULN	Number Analyzed	6 participants	6 participants	6 participants	19 participants	25 participants	11 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

14. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades
Description	Thyroid panel laboratory parameters/abnormalities: thyrotropin, free triiodothyronine (T3), free thyroxine (T4). Shift in thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing is reported in this outcome measure.
Time Frame	Baseline, 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Measure Type: Count of Participants; Unit of Measure: Participants
Triiodothyronine, Free: Low (at baseline) to Low (at post baseline)	Number Analyzed	2 participants	1 participants	2 participants	6 participants	9 participants	4 participants
		0 0.0%	1 100.0%	1 50.0%	3 50.0%	3 33.3%	4 100.0%
Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline)	Number Analyzed	2 participants	1 participants	2 participants	6 participants	9 participants	4 participants
		1 50.0%	0 0.0%	0 0.0%	3 50.0%	3 33.3%	0 0.0%
Triiodothyronine, Free: Low (at baseline) to High (at post baseline)	Number Analyzed	2 participants	1 participants	2 participants	6 participants	9 participants	4 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline)	Number Analyzed	2 participants	1 participants	2 participants	6 participants	9 participants	4 participants
		1 50.0%	0 0.0%	1 50.0%	0 0.0%	3 33.3%	0 0.0%
Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline)	Number Analyzed	4 participants	4 participants	5 participants	13 participants	18 participants	7 participants
		1 25.0%	0 0.0%	2 40.0%	0 0.0%	4 22.2%	0 0.0%
Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)	Number Analyzed	4 participants	4 participants	5 participants	13 participants	18 participants	7 participants
		3 75.0%	2 50.0%	3 60.0%	12 92.3%	12 66.7%	7 100.0%
Triiodothyronine, Free: Normal (at baseline) to High (at post baseline)	Number Analyzed	4 participants	4 participants	5 participants	13 participants	18 participants	7 participants
		0 0.0%	2 50.0%	0 0.0%	1 7.7%	0 0.0%	0 0.0%
Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)	Number Analyzed	4 participants	4 participants	5 participants	13 participants	18 participants	7 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 11.1%	0 0.0%
Triiodothyronine, Free: High (at baseline) to Low (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			0 0.0%
Triiodothyronine, Free: High (at baseline) to Normal (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			1 100.0%
Triiodothyronine, Free: High (at baseline) to High (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			0 0.0%
Triiodothyronine, Free: High (at baseline) to Missing (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			0 0.0%
Thyroxine, Free: Low (at baseline) to Low (at post baseline)	Number Analyzed	0 participants	0 participants	0 participants	1 participants	3 participants	0 participants
					0 0.0%	2 66.7%
Thyroxine, Free: Low (at baseline) to Normal (at post baseline)	Number Analyzed	0 participants	0 participants	0 participants	1 participants	3 participants	0 participants
					1 100.0%	0 0.0%
Thyroxine, Free: Low (at baseline) to High (at post baseline)	Number Analyzed	0 participants	0 participants	0 participants	1 participants	3 participants	0 participants
					0 0.0%	0 0.0%
Thyroxine, Free: Low (at baseline) to Missing (at post baseline)	Number Analyzed	0 participants	0 participants	0 participants	1 participants	3 participants	0 participants
					0 0.0%	1 33.3%
Thyroxine, Free: Normal (at baseline) to Low (at post baseline)	Number Analyzed	5 participants	5 participants	7 participants	15 participants	22 participants	10 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Thyroxine, Free: Normal (at baseline) to Normal (at post baseline)	Number Analyzed	5 participants	5 participants	7 participants	15 participants	22 participants	10 participants
		3 60.0%	2 40.0%	6 85.7%	12 80.0%	18 81.8%	8 80.0%
Thyroxine, Free: Normal (at baseline) to High (at post baseline)	Number Analyzed	5 participants	5 participants	7 participants	15 participants	22 participants	10 participants
		1 20.0%	3 60.0%	0 0.0%	3 20.0%	0 0.0%	2 20.0%
Thyroxine, Free: Normal (at baseline) to Missing (at post baseline)	Number Analyzed	5 participants	5 participants	7 participants	15 participants	22 participants	10 participants
		1 20.0%	0 0.0%	1 14.3%	0 0.0%	4 18.2%	0 0.0%
Thyroxine, Free: High (at baseline) to Low (at post baseline)	Number Analyzed	1 participants	1 participants	0 participants	3 participants	2 participants	1 participants
		0 0.0%	0 0.0%		0 0.0%	0 0.0%	0 0.0%
Thyroxine, Free: High (at baseline) to Normal (at post baseline)	Number Analyzed	1 participants	1 participants	0 participants	3 participants	2 participants	1 participants
		0 0.0%	0 0.0%		1 33.3%	0 0.0%	0 0.0%
Thyroxine, Free: High (at baseline) to High (at post baseline)	Number Analyzed	1 participants	1 participants	0 participants	3 participants	2 participants	1 participants
		1 100.0%	1 100.0%		2 66.7%	2 100.0%	1 100.0%
Thyroxine, Free: High (at baseline) to Missing (at post baseline)	Number Analyzed	1 participants	1 participants	0 participants	3 participants	2 participants	1 participants
		0 0.0%	0 0.0%		0 0.0%	0 0.0%	0 0.0%
Thyrotropin: Low (at baseline) to Low (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			0 0.0%
Thyrotropin: Low (at baseline) to Normal (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			1 100.0%
Thyrotropin: Low (at baseline) to High (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			0 0.0%
Thyrotropin: Low (at baseline) to Missing (at post baseline)	Number Analyzed	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
			0 0.0%
Thyrotropin: Normal (at baseline) to Low (at post baseline)	Number Analyzed	6 participants	4 participants	5 participants	18 participants	22 participants	10 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Thyrotropin: Normal (at baseline) to Normal (at post baseline)	Number Analyzed	6 participants	4 participants	5 participants	18 participants	22 participants	10 participants
		2 33.3%	4 100.0%	5 100.0%	14 77.8%	12 54.5%	5 50.0%
Thyrotropin: Normal (at baseline) to High (at post baseline)	Number Analyzed	6 participants	4 participants	5 participants	18 participants	22 participants	10 participants
		3 50.0%	0 0.0%	0 0.0%	4 22.2%	5 22.7%	5 50.0%
Thyrotropin: Normal (at baseline) to Missing (at post baseline)	Number Analyzed	6 participants	4 participants	5 participants	18 participants	22 participants	10 participants
		1 16.7%	0 0.0%	0 0.0%	0 0.0%	5 22.7%	0 0.0%
Thyrotropin: High (at baseline) to Low (at post baseline)	Number Analyzed	0 participants	1 participants	2 participants	1 participants	5 participants	1 participants
			0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Thyrotropin: High (at baseline) to Normal (at post baseline)	Number Analyzed	0 participants	1 participants	2 participants	1 participants	5 participants	1 participants
			0 0.0%	1 50.0%	0 0.0%	0 0.0%	1 100.0%
Thyrotropin: High (at baseline) to High (at post baseline)	Number Analyzed	0 participants	1 participants	2 participants	1 participants	5 participants	1 participants
			1 100.0%	0 0.0%	1 100.0%	5 100.0%	0 0.0%
Thyrotropin: High (at baseline) to Missing (at post baseline)	Number Analyzed	0 participants	1 participants	2 participants	1 participants	5 participants	1 participants
			0 0.0%	1 50.0%	0 0.0%	0 0.0%	0 0.0%

15. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding
Description	Urinalysis laboratory parameters/abnormalities: Decimal logarithm of reciprocal of hydrogen ion activity (pH), specific gravity, protein, glucose, ketones, nitrite, blood, leukocyte esterase, microscopy (if urine tested positive for blood or protein). Clinical significance was judged by investigator.
Time Frame	First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	6	6	7	19	27	11
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

16. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
Description	Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body temperature and weight. Low SBP: less than or equal to (<=)90 millimeter of mercury (mmHg) with decrease from baseline of >=20 mmHg. High SBP: >=160 mmHg with increase from baseline of >=20 mmHg. Low DBP: <=50 mmHg with decrease from baseline of >=15 mmHg. High DBP: >=100 mmHg with increase from baseline of >=15 mmHg. Low heart rate: <=50 beats/min with decrease from baseline of >=15 beats/min. High heart rate: >=120 beats/min with increase from baseline of >=15 beats/min. Low temperature: <=36 degree Celsius (C). High temperature: >=37.5 degree C. Low Weight: decrease from baseline >=20%. High weight: increase from baseline >=10%.
Time Frame	First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Outcome Measure Data

Analysis Population Description

Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Measure Type: Count of Participants; Unit of Measure: Participants
SBP: High	Number Analyzed	6 participants	6 participants	5 participants	19 participants	23 participants	8 participants
		3 50.0%	0 0.0%	0 0.0%	1 5.3%	2 8.7%	1 12.5%
SBP: Low	Number Analyzed	6 participants	6 participants	6 participants	18 participants	23 participants	11 participants
		1 16.7%	0 0.0%	0 0.0%	0 0.0%	1 4.3%	0 0.0%
DBP: High	Number Analyzed	6 participants	6 participants	6 participants	19 participants	23 participants	11 participants
		0 0.0%	0 0.0%	1 16.7%	1 5.3%	0 0.0%	0 0.0%
DBP: Low	Number Analyzed	6 participants	6 participants	6 participants	19 participants	23 participants	11 participants
		1 16.7%	0 0.0%	0 0.0%	0 0.0%	1 4.3%	0 0.0%
Heart Rate: High	Number Analyzed	6 participants	6 participants	6 participants	19 participants	21 participants	11 participants
		0 0.0%	1 16.7%	2 33.3%	2 10.5%	2 9.5%	0 0.0%
Heart Rate: Low	Number Analyzed	6 participants	6 participants	6 participants	19 participants	23 participants	11 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Temperature: High	Number Analyzed	6 participants	6 participants	5 participants	19 participants	22 participants	11 participants
		1 16.7%	0 0.0%	1 20.0%	1 5.3%	3 13.6%	1 9.1%
Temperature: Low	Number Analyzed	6 participants	5 participants	4 participants	17 participants	20 participants	11 participants
		4 66.7%	1 20.0%	2 50.0%	3 17.6%	5 25.0%	1 9.1%
Weight: High	Number Analyzed	5 participants	6 participants	6 participants	19 participants	22 participants	11 participants
		1 20.0%	0 0.0%	0 0.0%	0 0.0%	2 9.1%	0 0.0%
Weight: Low	Number Analyzed	5 participants	6 participants	6 participants	19 participants	22 participants	11 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 4.5%	0 0.0%

17. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382
Description	The lower limit of quantitation (LLOQ) for analyte ARRY-382 was 5.00 nanogram per milliliter (ng/mL).
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hour(hr) (±5 min), 2 hours(hrs) (±10 min), 4 hrs (±20 min) and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382. Here "Number Analyzed" signifies number of participants evaluated for given time points.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram per milliliter
Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	6 participants	5 participants	7 participants	17 participants	26 participants	11 participants
		283; (422%)	49.7; (1130%)	305; (263%)	664; (194%)	373; (282%)	695; (145%)
Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		542; (78.8%)	497; (201%)	827; (64.2%)	1060; (65.8%)	982; (101%)	1160; (57.2%)
Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		530; (37.9%)	845; (49.0%)	1130; (50.0%)	1010; (44.7%)	976; (72.6%)	937; (54.5%)
Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	8 participants
		384; (26.3%)	566; (28.8%)	757; (46.8%)	683; (43.7%)	662; (76.7%)	500; (52.6%)
Cycle 1 Day 15 / Pre ARRY-382 dose	Number Analyzed	5 participants	3 participants	2 participants	10 participants	16 participants	7 participants
		616; (43.0%)	533; (34.2%)	888 [1]; (NA%)	862; (57.3%)	918; (79.1%)	485; (117%)
Cycle 2 Day 1 / Pre ARRY-382 dose	Number Analyzed	4 participants	3 participants	2 participants	6 participants	3 participants	5 participants
		576; (59.5%)	762; (6.44%)	1040 [1]; (NA%)	330; (2050%)	1550; (18.8%)	438; (86.5%)
Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	4 participants	2 participants	3 participants	5 participants	3 participants	5 participants
		1170; (76.5%)	1310 [1]; (NA%)	1430; (195%)	1320; (97.5%)	2000; (14.3%)	1220; (64.2%)
Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	4 participants
		1530; (45.2%)	1600; (106%)	2560; (117%)	1830; (92.2%)	3000; (9.01%)	1580; (79.6%)
Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	5 participants
		1200; (57.6%)	2030; (35.1%)	2120; (126%)	1630; (66.6%)	2900; (4.73%)	1450; (62.7%)
Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	Number Analyzed	4 participants	3 participants	3 participants	6 participants	3 participants	5 participants
		1100; (35.7%)	1680; (8.22%)	1440; (142%)	1530; (52.3%)	2150; (7.22%)	973; (75.5%)
Cycle 3 Day 1 / Pre ARRY-382 dose	Number Analyzed	3 participants	1 participants	0 participants	4 participants	5 participants	2 participants
		565; (39.5%)	305 [2]; (NA%)		554; (70.3%)	324; (391%)	336 [1]; (NA%)
Cycle 4 Day 1 / Pre ARRY-382 dose	Number Analyzed	2 participants	0 participants	0 participants	4 participants	4 participants	1 participants
		405 [1]; (NA%)			1080; (119%)	728; (85.2%)	522 [2]; (NA%)
Cycle 5 Day 1 / Pre ARRY-382 dose	Number Analyzed	1 participants	0 participants	0 participants	3 participants	3 participants	1 participants
		NA [3]; (NA%)			92.6; (13300%)	1000; (35.1%)	76.6 [2]; (NA%)
Cycle 6 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	2 participants	1 participants
					798 [2]; (NA%)	1100 [1]; (NA%)	518 [2]; (NA%)
Cycle 7 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
					573 [2]; (NA%)		505 [2]; (NA%)
Cycle 8 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					424 [2]; (NA%)
Cycle 9 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					350 [2]; (NA%)
Cycle 10 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					244 [2]; (NA%)

[1]

As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.

[2]

Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.

[3]

Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.

18. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099
Description	Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469099 was reported in this outcome measure. The LLOQ for analyte AR00469099 was 1.00 ng/mL.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00469099. Here "Number Analyzed" signifies number of participants evaluated for given time points.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram per milliliter
Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	6 participants	5 participants	7 participants	17 participants	26 participants	11 participants
		10.6; (750%)	NA [1]; (NA%)	8.57; (404%)	21.0; (234%)	7.95; (493%)	22.6; (164%)
Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		36.3; (219%)	19.6; (495%)	57.2; (151%)	66.2; (80.5%)	54.7; (177%)	60.8; (52.9%)
Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		69.5; (128%)	83.6; (69.2%)	170; (72.6%)	110; (48.9%)	113; (109%)	89.1; (39.5%)
Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	8 participants
		74.9; (85.3%)	96.4; (62.9%)	205; (88.7%)	119; (49.5%)	132; (101%)	75.7; (41.6%)
Cycle 1 Day 15 / Pre ARRY-382 dose	Number Analyzed	5 participants	3 participants	2 participants	10 participants	16 participants	7 participants
		136; (30.8%)	73.7; (62.1%)	190 [2]; (NA%)	210; (78.8%)	250; (172%)	83.3; (132%)
Cycle 2 Day 1 / Pre ARRY-382 dose	Number Analyzed	4 participants	3 participants	2 participants	6 participants	3 participants	5 participants
		136; (67.7%)	199; (82.5%)	188 [2]; (NA%)	96.5; (2860%)	511; (189%)	77.1; (85.2%)
Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	4 participants	2 participants	3 participants	5 participants	3 participants	5 participants
		133; (72.0%)	245 [2]; (NA%)	177; (94.7%)	254; (29.2%)	475; (173%)	102; (68.2%)
Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	4 participants
		166; (66.0%)	166; (133%)	241; (73.8%)	272; (36.2%)	510; (174%)	133; (54.1%)
Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	5 participants
		177; (89.6%)	208; (129%)	305; (62.0%)	298; (55.6%)	544; (168%)	157; (50.7%)
Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	Number Analyzed	4 participants	3 participants	3 participants	6 participants	3 participants	5 participants
		210; (57.5%)	320; (71.9%)	313; (77.8%)	324; (44.1%)	561; (152%)	146; (58.5%)
Cycle 3 Day 1 / Pre ARRY-382 dose	Number Analyzed	3 participants	1 participants	0 participants	4 participants	5 participants	2 participants
		121; (81.8%)	31.0 [3]; (NA%)		123; (210%)	70.6; (243%)	54.0 [2]; (NA%)
Cycle 4 Day 1 / Pre ARRY-382 dose	Number Analyzed	2 participants	0 participants	0 participants	4 participants	4 participants	1 participants
		79.9 [2]; (NA%)			157; (228%)	138; (30.0%)	70.3 [3]; (NA%)
Cycle 5 Day 1 / Pre ARRY-382 dose	Number Analyzed	1 participants	0 participants	0 participants	3 participants	3 participants	1 participants
		NA [1]; (NA%)			11.5; (4020%)	170; (10.4%)	7.92 [3]; (NA%)
Cycle 6 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	2 participants	1 participants
					86.9 [3]; (NA%)	141 [2]; (NA%)	110 [3]; (NA%)
Cycle 7 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
					61.5 [3]; (NA%)		103 [3]; (NA%)
Cycle 8 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					42.7 [3]; (NA%)
Cycle 9 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					30.6 [3]; (NA%)
Cycle 10 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					27.0 [3]; (NA%)

[1]

Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.

[2]

As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.

[3]

Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.

19. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100
Description	Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469100 was reported in this outcome measure. The LLOQ for analyte AR00469100 was 1.00 ng/mL.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00469100. Here "Number Analyzed" signifies number of participants evaluated for given time points.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram per milliliter
Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	6 participants	5 participants	7 participants	17 participants	26 participants	11 participants
		19.5; (667%)	NA [1]; (NA%)	16.6; (584%)	61.0; (337%)	21.3; (553%)	75.4; (131%)
Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		47.1; (109%)	43.0; (468%)	71.0; (96.9%)	114; (69.1%)	81.9; (150%)	123; (51.2%)
Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		41.7; (79.2%)	82.7; (55.7%)	110; (40.5%)	102; (62.0%)	85.5; (84.8%)	101; (46.8%)
Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	8 participants
		28.2; (71.2%)	53.9; (42.5%)	67.7; (40.5%)	65.4; (64.8%)	56.4; (83.3%)	44.0; (50.5%)
Cycle 1 Day 15 / Pre ARRY-382 dose	Number Analyzed	5 participants	3 participants	2 participants	10 participants	16 participants	7 participants
		70.7; (81.2%)	69.4; (24.5%)	116 [2]; (NA%)	106; (94.1%)	96.0; (85.3%)	60.8; (121%)
Cycle 2 Day 1 / Pre ARRY-382 dose	Number Analyzed	4 participants	3 participants	2 participants	6 participants	3 participants	5 participants
		60.1; (103%)	107; (45.5%)	146 [2]; (NA%)	35.2; (977%)	184; (91.1%)	57.1; (99.2%)
Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	4 participants	2 participants	3 participants	5 participants	3 participants	5 participants
		105; (98.3%)	169 [2]; (NA%)	138; (228%)	116; (75.2%)	191; (92.5%)	173; (39.1%)
Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	4 participants
		138; (81.9%)	196; (81.9%)	268; (141%)	165; (81.7%)	265; (65.5%)	226; (66.5%)
Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	5 participants
		108; (108%)	228; (39.5%)	219; (131%)	139; (57.4%)	264; (75.1%)	164; (67.5%)
Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	Number Analyzed	4 participants	3 participants	3 participants	6 participants	3 participants	5 participants
		104; (75.9%)	210; (27.1%)	161; (158%)	124; (39.5%)	218; (74.8%)	107; (77.8%)
Cycle 3 Day 1 / Pre ARRY-382 dose	Number Analyzed	3 participants	1 participants	0 participants	4 participants	5 participants	2 participants
		63.2; (108%)	57.3 [3]; (NA%)		73.2; (73.5%)	54.8; (255%)	32.7 [2]; (NA%)
Cycle 4 Day 1 / Pre ARRY-382 dose	Number Analyzed	2 participants	0 participants	0 participants	4 participants	4 participants	1 participants
		31.1 [2]; (NA%)			108; (109%)	75.5; (88.7%)	67.6 [3]; (NA%)
Cycle 5 Day 1 / Pre ARRY-382 dose	Number Analyzed	1 participants	0 participants	0 participants	3 participants	3 participants	1 participants
		NA [1]; (NA%)			14.0; (6560%)	112; (46.2%)	11.7 [3]; (NA%)
Cycle 6 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	2 participants	1 participants
					110 [3]; (NA%)	148 [2]; (NA%)	72.8 [3]; (NA%)
Cycle 7 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
					73.2 [3]; (NA%)		67.4 [3]; (NA%)
Cycle 8 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					51.3 [3]; (NA%)
Cycle 9 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					44.0 [3]; (NA%)
Cycle 10 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					33.8 [3]; (NA%)

[1]

Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.

[2]

As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.

[3]

Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.

20. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870
Description	Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00470870 was reported in this outcome measure. The LLOQ for analyte AR00470870 was 1.00 ng/mL.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of metabolite AR00470870. Here "Number Analyzed" signifies number of participants evaluated for given time points.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram per milliliter
Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	6 participants	5 participants	7 participants	17 participants	26 participants	11 participants
		14.6; (835%)	NA [1]; (NA%)	11.7; (410%)	46.9; (403%)	12.6; (1100%)	71.7; (125%)
Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		49.4; (193%)	36.7; (2940%)	68.7; (113%)	140; (97.9%)	74.8; (277%)	189; (59.5%)
Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	11 participants
		64.5; (101%)	159; (106%)	182; (73.7%)	191; (59.9%)	129; (116%)	220; (46.9%)
Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	Number Analyzed	6 participants	6 participants	7 participants	17 participants	26 participants	8 participants
		53.7; (78.4%)	144; (71.3%)	162; (52.6%)	150; (56.8%)	123; (90.1%)	148; (46.7%)
Cycle 1 Day 15 / Pre ARRY-382 dose	Number Analyzed	5 participants	3 participants	2 participants	10 participants	16 participants	7 participants
		105; (86.9%)	255; (11.0%)	231 [2]; (NA%)	259; (49.3%)	307; (74.0%)	242; (33.5%)
Cycle 2 Day 1 / Pre ARRY-382 dose	Number Analyzed	4 participants	3 participants	2 participants	6 participants	3 participants	5 participants
		99.1; (80.8%)	294; (49.3%)	216 [2]; (NA%)	83.4; (2600%)	285; (58.4%)	224; (34.1%)
Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	Number Analyzed	4 participants	2 participants	3 participants	5 participants	3 participants	5 participants
		122; (63.9%)	377 [2]; (NA%)	206; (68.5%)	244; (58.1%)	279; (53.8%)	316; (26.4%)
Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	4 participants
		165; (49.3%)	444; (29.0%)	283; (68.8%)	337; (70.2%)	310; (47.2%)	462; (16.9%)
Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	Number Analyzed	4 participants	4 participants	3 participants	6 participants	3 participants	5 participants
		149; (54.4%)	503; (26.8%)	327; (61.2%)	320; (65.9%)	348; (40.3%)	486; (18.9%)
Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	Number Analyzed	4 participants	3 participants	3 participants	6 participants	3 participants	5 participants
		151; (58.9%)	460; (37.6%)	306; (47.9%)	337; (55.3%)	345; (36.1%)	401; (19.2%)
Cycle 3 Day 1 / Pre ARRY-382 dose	Number Analyzed	3 participants	1 participants	0 participants	4 participants	5 participants	2 participants
		118; (88.7%)	250 [3]; (NA%)		156; (87.0%)	194; (65.0%)	194 [2]; (NA%)
Cycle 4 Day 1 / Pre ARRY-382 dose	Number Analyzed	2 participants	0 participants	0 participants	4 participants	4 participants	1 participants
		77.4 [2]; (NA%)			161; (113%)	263; (13.5%)	158 [3]; (NA%)
Cycle 5 Day 1 / Pre ARRY-382 dose	Number Analyzed	1 participants	0 participants	0 participants	3 participants	3 participants	1 participants
		NA [1]; (NA%)			16.4; (10600%)	268; (18.2%)	33.8 [3]; (NA%)
Cycle 6 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	2 participants	1 participants
					73.5 [3]; (NA%)	419 [2]; (NA%)	192 [3]; (NA%)
Cycle 7 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
					60.7 [3]; (NA%)		236 [3]; (NA%)
Cycle 8 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					62.8 [3]; (NA%)
Cycle 9 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					73.8 [3]; (NA%)
Cycle 10 Day 1 / Pre ARRY-382 dose	Number Analyzed	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
					90.6 [3]; (NA%)

[1]

Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.

[2]

As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.

[3]

Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.

21. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Description	AUCtau was defined as area under the plasma concentration-time curve over the dosing interval, where dosing interval was 24 hours.
Time Frame	0 to 24 hrs after administration of ARRY-382 on Day 1 of Cycle 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	4	4	3	5	4	5
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: hour*nanogram per milliliter
ARRY-382	22800; (44.2%)	30600; (26.6%)	30800; (130%)	32100; (65.7%)	47100; (10.2%)	20700; (70.6%)
AR00469099	4150; (63.5%)	4530; (106%)	5880; (78.8%)	7920; (18.9%)	14200; (123%)	2840; (61.8%)
AR00469100	2170; (85.9%)	3860; (33.9%)	3510; (142%)	2670; (53.4%)	5360; (62.8%)	2480; (73.9%)
AR00470870	3180; (59.0%)	9810; (29.3%)	6200; (45.2%)	6850; (61.2%)	7940; (36.9%)	8220; (20.3%)

22. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Description	Cmax was obtained from plasma concentration time curve. Cmax at single dose was reported at Cycle1 Day 1 and Cmax at steady state was reported at Cycle 2 Day 1.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram per milliliter
Cycle 1 Day 1 ARRY-382	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		773; (60.2%)	995; (68.9%)	1330; (39.6%)	1240; (62.1%)	1290; (75.6%)	1260; (53.9%)
Cycle 2 Day 1 ARRY-382	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		1560; (41.3%)	2260; (36.6%)	2560; (117%)	2130; (60.4%)	2820; (15.1%)	1580; (64.8%)
Cycle 1 Day 1 AR00469099	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		84.0; (102%)	100; (59.8%)	219; (83.8%)	119; (50.9%)	142; (97.9%)	95.4; (43.2%)
Cycle 2 Day 1 AR00469099	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		212; (57.3%)	241; (103%)	328; (75.6%)	328; (44.0%)	646; (111%)	161; (50.8%)
Cycle 1 Day 1 AR00469100	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		61.2; (78.3%)	104; (86.5%)	122; (41.7%)	132; (70.0%)	116; (98.3%)	138; (46.5%)
Cycle 2 Day 1 AR00469100	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		138; (81.6%)	257; (36.4%)	268; (141%)	181; (56.9%)	279; (54.9%)	215; (52.5%)
Cycle 1 Day 1 AR00470870	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		70.1; (95.1%)	174; (92.5%)	196; (58.5%)	193; (60.5%)	147; (98.9%)	231; (50.8%)
Cycle 2 Day 1 AR00470870	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		172; (51.6%)	534; (22.0%)	333; (60.7%)	373; (60.6%)	363; (30.9%)	486; (18.9%)

23. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Description	Measured concentration at the pre-dose at steady-state.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration) on Day 1 of Cycle 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed	4	4	3	5	4	5
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram per milliliter
ARRY-382	576; (59.5%)	667; (27.7%)	627; (126%)	878; (70.1%)	1480; (17.5%)	438; (86.5%)
AR00469099	136; (67.7%)	146; (105%)	161; (105%)	277; (27.1%)	557; (136%)	77.1; (85.2%)
AR00469100	60.1; (103%)	96.0; (43.9%)	83.6; (137%)	82.4; (57.1%)	193; (71.3%)	57.1; (99.2%)
AR00470870	99.1; (80.8%)	313; (41.7%)	185; (27.9%)	232; (58.5%)	302; (48.1%)	224; (34.1%)

24. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Description	Tmax was obtained from plasma concentration time curve. Tmax at single dose was reported at Cycle 1 Day 1 and Tmax at steady state was reported at Cycle 2 Day 1.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Median (Full Range); Unit of Measure: hours
Cycle 1 Day 1 ARRY-382	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		2.00; (1.00 to 7.95)	4.01; (1.25 to 4.05)	4.07; (0.983 to 8.00)	1.97; (0.950 to 4.17)	2.00; (0.967 to 8.00)	2.00; (1.00 to 4.10)
Cycle 2 Day 1 ARRY-382	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		2.00; (2.00 to 7.95)	4.18; (1.85 to 7.48)	1.98; (1.97 to 2.00)	2.00; (1.00 to 7.50)	3.03; (2.00 to 4.08)	2.00; (1.83 to 4.17)
Cycle 1 Day 1 AR00469099	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		7.98; (4.00 to 8.02)	7.81; (3.97 to 8.00)	7.95; (4.00 to 8.02)	5.88; (3.98 to 8.00)	5.83; (1.92 to 8.03)	4.17; (2.00 to 8.00)
Cycle 2 Day 1 AR00469099	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		7.94; (4.10 to 8.05)	7.68; (3.85 to 8.00)	8.00; (4.00 to 8.00)	7.50; (4.00 to 8.00)	5.90; (0.00 to 8.00)	4.05; (2.00 to 7.50)
Cycle 1 Day 1 AR00469100	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		2.00; (1.00 to 4.07)	2.98; (1.25 to 4.05)	4.07; (0.983 to 8.00)	2.00; (1.00 to 4.17)	2.00; (0.967 to 8.02)	2.00; (1.00 to 4.10)
Cycle 2 Day 1 AR00469100	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		2.00; (2.00 to 7.95)	3.03; (1.85 to 7.48)	1.98; (1.97 to 2.00)	1.98; (1.00 to 7.50)	3.90; (2.00 to 4.03)	2.00; (0.917 to 3.75)
Cycle 1 Day 1 AR00470870	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		3.00; (2.00 to 8.02)	4.03; (1.83 to 8.00)	4.07; (4.00 to 8.00)	4.00; (2.00 to 7.58)	4.07; (1.92 to 8.02)	3.80; (1.88 to 4.15)
Cycle 2 Day 1 AR00470870	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		3.00; (2.00 to 7.95)	4.18; (1.85 to 7.48)	8.00; (4.00 to 8.00)	4.03; (1.95 to 7.50)	5.78; (4.00 to 8.00)	4.05; (3.75 to 4.17)

25. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Description	Different MR reported for single dose calculated at Cycle 1 Day 1 were as follows: 1) MRAUClast = ratio of AUClast values of the metabolite compared to parent, corrected for molecular weight, where AUClast was area under the plasma concentration-time curve from zero to the last measurable time point; 2) MRCmax = ratio of Cmax values of the metabolite compared to parent, corrected for molecular weight. Different MR reported for steady state calculated at Cycle 2 Day 1 were as follows: 1) MRAUCtau,ss = ratio of AUCtau,ss values of the metabolite compared to parent, corrected for molecular weight, where AUCtau was area under the plasma concentration-time curve over a dosing interval at steady-state; 2) MRCmax,ss = Ratio of Cmax,ss values of the metabolite compared to parent, corrected for molecular weight.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration),1 hrs (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		6	6	7	19	27	11
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ratio
Cycle 1 Day 1 AR00469099 MRAUClast	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		0.115; (86.8%)	0.101; (47.9%)	0.151; (70.9%)	0.101; (45.7%)	0.108; (63.4%)	0.0821; (31.3%)
Cycle 1 Day 1 AR00469099 MRCmax	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		0.106; (58.8%)	0.0979; (74.9%)	0.160; (79.5%)	0.0929; (46.5%)	0.107; (71.8%)	0.0734; (38.3%)
Cycle 2 Day 1 AR00469099 MRAUCtau,ss	Number Analyzed	4 participants	4 participants	3 participants	5 participants	4 participants	5 participants
		0.177; (35.6%)	0.144; (80.3%)	0.186; (84.6%)	0.240; (69.0%)	0.292; (132%)	0.134; (27.5%)
Cycle 2 Day 1 AR00469099 MRCmax,ss	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		0.132; (20.5%)	0.103; (68.2%)	0.125; (74.8%)	0.150; (89.9%)	0.222; (108%)	0.0991; (24.0%)
Cycle 1 Day 1 AR00469100 MRAUClast	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		0.0817; (40.7%)	0.101; (33.4%)	0.0934; (31.0%)	0.104; (39.3%)	0.0883; (41.2%)	0.108; (22.9%)
Cycle 1 Day 1 AR00469100 MRCmax	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		0.0811; (45.0%)	0.107; (35.0%)	0.0941; (21.8%)	0.109; (47.2%)	0.0923; (41.3%)	0.112; (29.8%)
Cycle 2 Day 1 AR00469100 MRAUCtau,ss	Number Analyzed	4 participants	4 participants	3 participants	5 participants	4 participants	5 participants
		0.0978; (43.8%)	0.129; (27.1%)	0.117; (13.1%)	0.0853; (13.8%)	0.117; (66.4%)	0.123; (40.8%)
Cycle 2 Day 1 AR00469100 MRCmax,ss	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		0.0909; (41.4%)	0.116; (29.3%)	0.108; (24.5%)	0.0873; (19.2%)	0.101; (52.8%)	0.140; (44.3%)
Cycle 1 Day 1 AR00470870 MRAUClast	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		0.0946; (104%)	0.159; (42.7%)	0.127; (44.9%)	0.151; (71.1%)	0.106; (64.0%)	0.176; (72.4%)
Cycle 1 Day 1 AR00470870 MRCmax	Number Analyzed	6 participants	6 participants	7 participants	18 participants	26 participants	11 participants
		0.0775; (119%)	0.149; (26.6%)	0.126; (30.4%)	0.133; (78.0%)	0.0974; (51.4%)	0.156; (71.6%)
Cycle 2 Day 1 AR00470870 MRAUCtau,ss	Number Analyzed	4 participants	4 participants	3 participants	5 participants	4 participants	5 participants
		0.119; (80.2%)	0.273; (43.1%)	0.172; (66.7%)	0.182; (69.3%)	0.144; (41.1%)	0.340; (59.0%)
Cycle 2 Day 1 AR00470870 MRCmax,ss	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		0.0941; (84.4%)	0.201; (36.1%)	0.111; (42.7%)	0.150; (66.6%)	0.110; (31.3%)	0.263; (59.6%)

26. Secondary Outcome

Title	Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870)
Description	Accumulation ratio was calculated and reported for Cmax as RCmax and for AUC as RAUC. RCmax = Cmax at steady-state on Day 1 of Cycle 2 divided by Cmax on Day 1 of Cycle 1. RAUC = AUC from zero to 8 hours after drug administration at steady-state on Day 1 of Cycle 2 divided by AUC from zero to 8 hours after drug administration on Day 1 of Cycle 1.
Time Frame	Pre dose of ARRY-382 (120 minutes prior to administration),1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2

Outcome Measure Data

Analysis Population Description

PK set included all participants who had received any active study intervention (ARRY-382), with at least one postdose blood draw to determineplasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

Arm/Group Title		Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description:		Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Overall Number of Participants Analyzed		4	4	3	6	4	5
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ratio
Cycle 2 Day 1 ARRY-382 RAUC	Number Analyzed	3 participants	2 participants	2 participants	3 participants	3 participants	4 participants
		3.03; (47.9%)	1.92 [1]; (NA%)	3.52 [1]; (NA%)	2.67; (36.2%)	3.41; (23.6%)	1.87; (16.7%)
Cycle 2 Day 1 ARRY-382 RCmax	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		2.53; (48.2%)	2.51; (95.7%)	2.28; (54.2%)	2.52; (39.9%)	2.07; (53.6%)	1.62; (24.7%)
Cycle 2 Day 1 AR00469099 RAUC	Number Analyzed	3 participants	1 participants	2 participants	2 participants	3 participants	4 participants
		4.03; (93.0%)	4.36 [2]; (NA%)	4.28 [1]; (NA%)	4.67 [1]; (NA%)	4.95; (41.8%)	2.07; (23.8%)
Cycle 2 Day 1 AR00469099 RCmax	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		3.03; (53.4%)	2.54; (52.0%)	2.47; (38.5%)	3.19; (36.7%)	3.56; (48.4%)	1.93; (37.4%)
Cycle 2 Day 1 AR00469100 RCmax	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		2.67; (46.1%)	2.60; (157%)	2.50; (65.1%)	2.44; (41.3%)	2.08; (49.0%)	1.76; (29.5%)
Cycle 2 Day 1 AR00469100 RAUC	Number Analyzed	3 participants	2 participants	2 participants	3 participants	3 participants	4 participants
		3.49; (51.7%)	1.97 [1]; (NA%)	3.96 [1]; (NA%)	2.64; (36.3%)	3.84; (13.5%)	1.93; (23.0%)
Cycle 2 Day 1 AR00470870 RAUC	Number Analyzed	3 participants	1 participants	2 participants	2 participants	3 participants	4 participants
		3.47; (94.9%)	4.48 [2]; (NA%)	2.73 [1]; (NA%)	4.01 [1]; (NA%)	3.30; (61.9%)	2.03; (23.9%)
Cycle 2 Day 1 AR00470870 RCmax	Number Analyzed	4 participants	4 participants	3 participants	6 participants	4 participants	5 participants
		2.72; (54.5%)	3.59; (95.3%)	2.02; (20.1%)	2.39; (48.6%)	2.03; (38.7%)	1.77; (31.0%)

[1]

As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.

[2]

Since only 1 evaluable participant, geometric coefficient of variation could not be calculated.

Adverse Events

Time Frame	Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)
Adverse Event Reporting Description	Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Arm/Group Title	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
Arm/Group Description	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
All-Cause Mortality
	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/6 (66.67%)	6/6 (100.00%)	5/7 (71.43%)	1/1 (100.00%)	1/2 (50.00%)	10/19 (52.63%)	20/27 (74.07%)	5/11 (45.45%)
Serious Adverse Events
	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/6 (50.00%)	1/6 (16.67%)	3/7 (42.86%)	1/1 (100.00%)	1/2 (50.00%)	8/19 (42.11%)	15/27 (55.56%)	5/11 (45.45%)
Blood and lymphatic system disorders
Anaemia * 1	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Cardiac disorders
Atrioventricular block * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Cardiac failure congestive * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Gastrointestinal disorders
Gastrointestinal haemorrhage * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Haematemesis * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Nausea * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Vomiting * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Abdominal pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	1/11 (9.09%)
Ascites * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Constipation * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Enterocolitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Gastric perforation * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Ileus * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Intestinal obstruction * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Upper gastrointestinal haemorrhage * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
General disorders
Pyrexia * 1	0/6 (0.00%)	1/6 (16.67%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	0/11 (0.00%)
Hepatobiliary disorders
Hepatitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Hyperbilirubinaemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Infections and infestations
Peritonitis * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Pneumonia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	1/11 (9.09%)
Pneumococcal sepsis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Urinary tract infection * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Urosepsis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Injury, poisoning and procedural complications
Head injury * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Investigations
Alanine aminotransferase increased * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Aspartate aminotransferase increased * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Blood bilirubin increased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Urine output decreased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Metabolism and nutrition disorders
Dehydration * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	3/27 (11.11%)	0/11 (0.00%)
Hyponatraemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Nervous system disorders
Cerebrovascular accident * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Cerebral thrombosis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Metabolic encephalopathy * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Psychiatric disorders
confusional state * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	1/1 (100.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Renal and urinary disorders
Acute kidney injury * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis * 1	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Pulmonary embolism * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Respiratory failure * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Pleural effusion * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	2/11 (18.18%)
Aspiration * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Chronic obstructive pulmonary disease * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Haemoptysis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Skin and subcutaneous tissue disorders
Rash morbilliform * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Rash maculo-papular * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Vascular disorders
Hypotension * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
1 Term from vocabulary, MedDRA version 21.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/6 (100.00%)	6/6 (100.00%)	6/7 (85.71%)	1/1 (100.00%)	2/2 (100.00%)	19/19 (100.00%)	26/27 (96.30%)	10/11 (90.91%)
Blood and lymphatic system disorders
Anaemia * 1	1/6 (16.67%)	0/6 (0.00%)	4/7 (57.14%)	0/1 (0.00%)	0/2 (0.00%)	5/19 (26.32%)	9/27 (33.33%)	1/11 (9.09%)
Thrombocytopenia * 1	0/6 (0.00%)	1/6 (16.67%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Leukopenia * 1	0/6 (0.00%)	2/6 (33.33%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Neutropenia * 1	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Coagulopathy * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Iron deficiency anaemia * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Lymphadenopathy * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Cardiac disorders
Atrial fibrillation * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Cardiac failure congestive * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Tachycardia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Ear and labyrinth disorders
Hypoacusis * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Endocrine disorders
Hypothyroidism * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	1/11 (9.09%)
Thyroiditis acute * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Hyperthyroidism * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Thyroid mass * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Eye disorders
Dry eye * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Lacrimation increased * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Periorbital oedema * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	1/11 (9.09%)
Vision blurred * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Blepharitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Eye swelling * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Eyelid oedema * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Gastrointestinal disorders
Nausea * 1	1/6 (16.67%)	1/6 (16.67%)	3/7 (42.86%)	0/1 (0.00%)	0/2 (0.00%)	9/19 (47.37%)	12/27 (44.44%)	5/11 (45.45%)
Vomiting * 1	1/6 (16.67%)	2/6 (33.33%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	8/19 (42.11%)	9/27 (33.33%)	1/11 (9.09%)
Dry mouth * 1	2/6 (33.33%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	0/11 (0.00%)
Abdominal pain * 1	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	4/19 (21.05%)	6/27 (22.22%)	3/11 (27.27%)
Constipation * 1	0/6 (0.00%)	0/6 (0.00%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	7/27 (25.93%)	3/11 (27.27%)
Abdominal pain upper * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	1/11 (9.09%)
Anal haemorrhage * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Ascites * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Dysphagia * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Gastric varices * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Gastrooesophageal reflux disease * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	1/11 (9.09%)
Pancreatitis * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Pancreatitis acute * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Stomatitis * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	1/11 (9.09%)
Diarrhoea * 1	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	8/19 (42.11%)	4/27 (14.81%)	2/11 (18.18%)
Abdominal distension * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	3/27 (11.11%)	1/11 (9.09%)
Flatulence * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	2/27 (7.41%)	0/11 (0.00%)
Colitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Abdominal discomfort * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Abdominal pain lower * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Anal fistula * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Anal incontinence * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Dyspepsia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Eructation * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Haematemesis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Haematochezia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Haemorrhoids * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Lower gastrointestinal haemorrhage * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Proctalgia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Rectal haemorrhage * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Rectal tenesmus * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Small intestinal obstruction * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
General disorders
Fatigue * 1	2/6 (33.33%)	2/6 (33.33%)	3/7 (42.86%)	0/1 (0.00%)	1/2 (50.00%)	10/19 (52.63%)	16/27 (59.26%)	3/11 (27.27%)
Pyrexia * 1	2/6 (33.33%)	1/6 (16.67%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	3/11 (27.27%)
Chills * 1	2/6 (33.33%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	0/11 (0.00%)
Asthenia * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	0/11 (0.00%)
Influenza like illness * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	1/11 (9.09%)
Oedema peripheral * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	3/19 (15.79%)	1/27 (3.70%)	1/11 (9.09%)
Pain * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Non-cardiac chest pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	1/19 (5.26%)	1/27 (3.70%)	1/11 (9.09%)
Gait disturbance * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Performance status decreased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	0/27 (0.00%)	0/11 (0.00%)
Catheter site pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Chest discomfort * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Chest pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Early satiety * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Face oedema * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Localised oedema * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Malaise * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Temperature intolerance * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Thirst * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Hepatobiliary disorders
Hyperbilirubinaemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	0/11 (0.00%)
Autoimmune hepatitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Cholecystitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Jaundice * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Immune system disorders
Allergy to arthropod sting * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Infections and infestations
Bronchitis * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Cystitis * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Lung infection * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Oral candidiasis * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Pneumonia * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	1/11 (9.09%)
Upper respiratory tract infection * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Urinary tract infection * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	2/27 (7.41%)	1/11 (9.09%)
Candida infection * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Cellulitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Herpes zoster * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Pneumococcal sepsis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Skin infection * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Vaginal infection * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Injury, poisoning and procedural complications
Fall * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	0/11 (0.00%)
Fibula fracture * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Laceration * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Thermal burn * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Investigations
Aspartate aminotransferase increased * 1	2/6 (33.33%)	6/6 (100.00%)	4/7 (57.14%)	0/1 (0.00%)	0/2 (0.00%)	8/19 (42.11%)	9/27 (33.33%)	4/11 (36.36%)
Blood creatine phosphokinase increased * 1	2/6 (33.33%)	3/6 (50.00%)	3/7 (42.86%)	0/1 (0.00%)	0/2 (0.00%)	9/19 (47.37%)	5/27 (18.52%)	2/11 (18.18%)
Alanine aminotransferase increased * 1	2/6 (33.33%)	3/6 (50.00%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	3/19 (15.79%)	5/27 (18.52%)	4/11 (36.36%)
Blood alkaline phosphatase increased * 1	1/6 (16.67%)	2/6 (33.33%)	3/7 (42.86%)	0/1 (0.00%)	0/2 (0.00%)	5/19 (26.32%)	4/27 (14.81%)	0/11 (0.00%)
Lipase increased * 1	1/6 (16.67%)	4/6 (66.67%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	6/19 (31.58%)	1/27 (3.70%)	0/11 (0.00%)
Amylase increased * 1	1/6 (16.67%)	3/6 (50.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	4/19 (21.05%)	2/27 (7.41%)	0/11 (0.00%)
Weight decreased * 1	1/6 (16.67%)	0/6 (0.00%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	3/19 (15.79%)	1/27 (3.70%)	0/11 (0.00%)
Activated partial thromboplastin time prolonged * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Aldolase increased * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Blood bilirubin increased * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	3/27 (11.11%)	0/11 (0.00%)
Blood creatinine increased * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	2/27 (7.41%)	1/11 (9.09%)
Blood lactate dehydrogenase increased * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	1/11 (9.09%)
Blood pressure increased * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Electrocardiogram T wave abnormal * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Glomerular filtration rate decreased * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Heart rate increased * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Lymphocyte count decreased * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	3/27 (11.11%)	0/11 (0.00%)
Neutrophil count decreased * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Weight increased * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	1/11 (9.09%)
White blood cell count decreased * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
International normalised ratio increased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	3/27 (11.11%)	0/11 (0.00%)
Platelet count decreased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	0/11 (0.00%)
Ammonia increased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Blood magnesium decreased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Blood sodium decreased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Blood thyroid stimulating hormone increased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Creatinine renal clearance decreased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Prothrombin time prolonged * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Troponin increased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Urine output decreased * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Metabolism and nutrition disorders
Dehydration * 1	3/6 (50.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	5/19 (26.32%)	4/27 (14.81%)	2/11 (18.18%)
Decreased appetite * 1	2/6 (33.33%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	3/19 (15.79%)	9/27 (33.33%)	2/11 (18.18%)
Hypoalbuminaemia * 1	0/6 (0.00%)	0/6 (0.00%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	4/27 (14.81%)	0/11 (0.00%)
Hyponatraemia * 1	0/6 (0.00%)	0/6 (0.00%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	4/27 (14.81%)	1/11 (9.09%)
Hyperglycaemia * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	3/27 (11.11%)	1/11 (9.09%)
Hypocalcaemia * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	3/27 (11.11%)	0/11 (0.00%)
Hypokalaemia * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	4/19 (21.05%)	4/27 (14.81%)	1/11 (9.09%)
Hypomagnesaemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	2/11 (18.18%)
Hypophosphataemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	2/27 (7.41%)	0/11 (0.00%)
Hyperuricaemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Diabetes mellitus * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Fluid retention * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Hyperkalaemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Hypoglycaemia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/6 (0.00%)	2/6 (33.33%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Bone pain * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Flank pain * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Muscle spasms * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Muscular weakness * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Myalgia * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	2/27 (7.41%)	0/11 (0.00%)
Pathological fracture * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Back pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	1/19 (5.26%)	2/27 (7.41%)	2/11 (18.18%)
Groin pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Musculoskeletal chest pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Musculoskeletal discomfort * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Pain in extremity * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain * 1	0/6 (0.00%)	0/6 (0.00%)	2/7 (28.57%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Peritoneal neoplasm * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Nervous system disorders
Headache * 1	1/6 (16.67%)	1/6 (16.67%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	2/27 (7.41%)	3/11 (27.27%)
Dizziness * 1	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	2/27 (7.41%)	0/11 (0.00%)
Dementia * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Hypoaesthesia * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Syncope * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Neuropathy peripheral * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	2/27 (7.41%)	0/11 (0.00%)
Dysgeusia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	2/11 (18.18%)
Somnolence * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Akathisia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Dysgraphia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Hypogeusia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Memory impairment * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Myoclonus * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Restless legs syndrome * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Tremor * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Encephalopathy * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	1/1 (100.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Psychiatric disorders
Insomnia * 1	1/6 (16.67%)	1/6 (16.67%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	0/27 (0.00%)	0/11 (0.00%)
Depression * 1	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	2/27 (7.41%)	1/11 (9.09%)
Anxiety * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	1/11 (9.09%)
Confusional state * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	3/27 (11.11%)	0/11 (0.00%)
Hallucination * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Renal and urinary disorders
Dysuria * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Haematuria * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	1/11 (9.09%)
Proteinuria * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Micturition urgency * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	0/11 (0.00%)
Acute kidney injury * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Bladder spasm * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Chronic kidney disease * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Pollakiuria * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Urinary retention * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Urinary tract pain * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Reproductive system and breast disorders
Prostatic obstruction * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	2/6 (33.33%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	2/19 (10.53%)	1/27 (3.70%)	1/11 (9.09%)
Dyspnoea * 1	1/6 (16.67%)	1/6 (16.67%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	1/27 (3.70%)	4/11 (36.36%)
Dyspnoea exertional * 1	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Oropharyngeal pain * 1	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Productive cough * 1	2/6 (33.33%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Epistaxis * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Hypoxia * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Nasal congestion * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Pneumonitis * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Rhinitis allergic * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Pleural effusion * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	1/11 (9.09%)
Upper-airway cough syndrome * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	1/11 (9.09%)
Chronic obstructive pulmonary disease * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Dysphonia * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Laryngeal haemorrhage * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Pulmonary embolism * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus * 1	2/6 (33.33%)	2/6 (33.33%)	0/7 (0.00%)	0/1 (0.00%)	1/2 (50.00%)	0/19 (0.00%)	1/27 (3.70%)	1/11 (9.09%)
Rash maculo-papular * 1	1/6 (16.67%)	2/6 (33.33%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	0/27 (0.00%)	0/11 (0.00%)
Hyperhidrosis * 1	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	1/27 (3.70%)	1/11 (9.09%)
Nail ridging * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Night sweats * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Rash * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	0/27 (0.00%)	0/11 (0.00%)
Rash macular * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Dry skin * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	3/27 (11.11%)	0/11 (0.00%)
Ecchymosis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Erythema * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Pruritus generalised * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Rash erythematous * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Rash generalised * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Rash pruritic * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Vascular disorders
Hot flush * 1	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
Embolism * 1	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Hypertension * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	0/11 (0.00%)
Hypotension * 1	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	2/19 (10.53%)	3/27 (11.11%)	0/11 (0.00%)
Deep vein thrombosis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Flushing * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	1/19 (5.26%)	0/27 (0.00%)	0/11 (0.00%)
Lymphoedema * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	0/27 (0.00%)	1/11 (9.09%)
Phlebitis * 1	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/1 (0.00%)	0/2 (0.00%)	0/19 (0.00%)	1/27 (3.70%)	0/11 (0.00%)
1 Term from vocabulary, MedDRA version 21.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Johnson M, Dudek AZ, Sukari A, Call J, Kunk PR, Lewis K, Gainor JF, Sarantopoulos J, Lee P, Golden A, Harney A, Rothenberg SM, Zhang Y, Goldman JW. ARRY-382 in Combination with Pembrolizumab in Patients with Advanced Solid Tumors: Results from a Phase 1b/2 Study. Clin Cancer Res. 2022 Jun 13;28(12):2517-2526. doi: 10.1158/1078-0432.CCR-21-3009.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02880371
• Other Study ID Numbers: ARRAY-382-201; C4261001 ( Other Identifier: Alias Study Number )
• First Submitted: August 2, 2016
• First Posted: August 26, 2016
• Results First Submitted: April 4, 2022
• Results First Posted: June 16, 2022
• Last Update Posted: June 16, 2022