A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02407054

Recruitment Status : Completed

First Posted : April 2, 2015

Results First Posted : May 11, 2021

Last Update Posted : May 11, 2021

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Sponsor:

Collaborator:

Sarah Cannon Development Innovations

Information provided by (Responsible Party):

Eli Lilly and Company

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Prostate Cancer Metastatic
Interventions	Drug: LY3023414 Drug: Enzalutamide Drug: Placebo
Enrollment	142

Participant Flow

Recruitment Details
Pre-assignment Details	Participants who did not voluntarily withdraw, or who were not removed from the study due to adverse event (AE), non-compliance, or at their physician's decision were considered to be study completers.


Arm/Group Title	Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD	Part B: Placebo + 160 mg Enzalutamide QD
Arm/Group Description	Participants received 200 milligram...	Participants received 200 mg LY3023...	Participants received placebo in co...
Arm/Group Description	Participants received 200 milligrams (mg) LY3023414 orally twice daily (BID) during initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide orally QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days.	Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).	Participants received placebo in combination with 160 mg enzalutamide orally QD.
Period Title: Overall Study
Started	13	65	64
Received at Least One Dose of Study Drug	13	65	64
Completed	6	47	57
Not Completed	7	18	7
Reason Not Completed
Adverse Event	1	4	1
Non-compliance with Study	0	2	1
Physician Decision	1	3	3
Withdrawal by Subject	5	9	2

Baseline Characteristics

Arm/Group Title		Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD	Part B: Placebo + 160 mg Enzalutamide QD	Total
Arm/Group Description		Participants received 200 mg LY3023...	Participants received 200 mg LY3023...	Participants received placebo in co...	Total of all reporting groups
Arm/Group Description		Participants received 200 mg LY3023414 orally every 12 hours (BID) during initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide orally QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days.	Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).	Participants received placebo in combination with 160 mg enzalutamide orally QD.	Total of all reporting groups
Overall Number of Baseline Participants		13	65	64	142
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All participants who received at least one dose of study drug.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	13 participants	65 participants	64 participants	142 participants
		74.4 (8.43)	69.8 (8.30)	70.9 (9.07)	70.7 (8.70)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	65 participants	64 participants	142 participants
	Female	0	0	0	0
	Male	13	65	64	142
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	65 participants	64 participants	142 participants
	Hispanic or Latino	0	1	0	1
	Not Hispanic or Latino	11	61	63	135
	Unknown or Not Reported	2	3	1	6
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	65 participants	64 participants	142 participants
	American Indian or Alaska Native	0	0	1	1
	Asian	0	1	3	4
	Native Hawaiian or Other Pacific Islander	0	0	0	0
	Black or African American	2	6	4	12
	White	11	53	55	119
	More than one race	0	0	0	0
	Unknown or Not Reported	0	5	1	6
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	13 participants	65 participants	64 participants	142 participants
United States		13	65	64	142

Outcome Measures

1.Primary Outcome


Title	Part B: Progression Free Survival (PFS)
Description	PFS was defined as the time from randomization until the date of clini...
Description	PFS was defined as the time from randomization until the date of clinical (symptomatic or radiographic) and/or prostate specific antigen (PSA) disease progression per Prostate Cancer Clinical Trials Working Group (PCWG2) or death by any cause regardless of whether the participants withdraws from study drug or receives a subsequent anti-cancer therapy (as determined by the investigator). Participants who have not progressed or died at the time of assessment were censored at the time of the last date of assessment (tumor evaluation or PSA level).
Time Frame	Randomization to Measured Progressive Disease or Death from Any Cause (Up To 34 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in Part B. Per protocol, this analysis was planned for Part B only. Censored participants: Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD =19 and Part B: Placebo + 160 mg Enzalutamide QD =8.


Arm/Group Title	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD	Part B: Placebo + 160 mg Enzalutamide QD
Arm/Group Description:	Participants received 200 mg LY3023...	Participants received placebo in co...
Arm/Group Description:	Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).	Participants received placebo in combination with 160 mg enzalutamide orally QD.
Overall Number of Participants Analyzed	46	56
Median (95% Confidence Interval) Unit of Measure: months
	3.78 (2.89 to 5.06)	2.83 (2.27 to 3.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD, Part B: Placebo + 160 mg Enzalutamide QD
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.5871
	Confidence Interval	(2-Sided) 95% 0.3967 to 0.8690
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Part B: Time to Disease Progression (TTP)
Description	TTP was defined as time from randomization until the date of clinical ...
Description	TTP was defined as time from randomization until the date of clinical (symptomatic or radiographic) and/or prostate specific antigen (PSA) disease progression per Prostate Cancer Clinical Trials Working Group (PCWG2).
Time Frame	Randomization to Objective Disease Progression (Up To 34 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in Part B. Per protocol, this analysis was planned for Part B only. Censored participants: Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD=32 and Part B: Placebo + 160 mg Enzalutamide QD=22.


Arm/Group Title	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD	Part B: Placebo + 160 mg Enzalutamide QD
Arm/Group Description:	Participants received 200 mg LY3023...	Participants received placebo in co...
Arm/Group Description:	Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).	Participants received placebo in combination with 160 mg enzalutamide orally QD.
Overall Number of Participants Analyzed	33	42
Median (95% Confidence Interval) Unit of Measure: months
	5.06 (3.19 to 8.34)	3.61 (2.86 to 4.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD, Part B: Placebo + 160 mg Enzalutamide QD
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.6515
	Confidence Interval	(2-Sided) 95% 0.4123 to 1.0294
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Part B: Percentage of Participants With Prostate Specific Antigen Response
Description	PSA response was defined as more than 50% and 90% reduction from basel...
Description	PSA response was defined as more than 50% and 90% reduction from baseline to lowest post baseline value. 95% Confidence Intervals are based on Fisher's Exact Method.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in Part B. Per protocol, this analysis was planned for Part B only.


Arm/Group Title	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD	Part B: Placebo + 160 mg Enzalutamide QD
Arm/Group Description:	Participants received 200 mg LY3023...	Participants received placebo in co...
Arm/Group Description:	Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).	Participants received placebo in combination with 160 mg enzalutamide orally QD.
Overall Number of Participants Analyzed	65	64
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
50% PSA Response	21.5 (12.3 to 33.5)	25.0 (15.0 to 37.4)
90% PSA Response	7.6 (2.5 to 17.0)	9.3 (3.5 to 19.3)

4.Secondary Outcome


Title	Part A: Pharmacokinetic (PK): Area Under the Concentration-time Curve Over the Dosing Interval (AUCτ) of LY3023414
Description	PK: Area under the Concentration-time Curve Over the Dosing Interval (...
Description	PK: Area under the Concentration-time Curve Over the Dosing Interval (AUCτ) of LY3023414 Time Frame: Part A LY3023414 200 mg: Day-1 pre-dose, 1.5, 3, and 6 hours post LY3023414 dose, Cycle 1 Day 1 pre-dose of LY3023414 and enzalutamide, and Part A Day 15 Pre-dose of LY3023414 and enzalutamide 1.5, 3, and 6 hours post LY3023414 dose;
Time Frame	Part A: 200 mg LY3023414 + 160 mg Enzalutamide: Cycle 1 Day 15 Pre-dose of LY3023414 and enzalutamide 1.5, 3, and 6 hours post LY3023414 dose

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable PK data in Part A.


Arm/Group Title	Part A: 200 mg LY3023414	Part A: 200 mg LY3023414 BID + 160 mg Enzalutamide
Arm/Group Description:	Participants received 200 mg LY3023...	Participants received 200 mg LY3023...
Arm/Group Description:	Participants received 200 mg LY3023414 orally every 12 hours (BID) during initial week to assess pharmacokinetics (PK).	Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD) at the beginning Cycle 1 Day 1.
Overall Number of Participants Analyzed	11	8
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: nanogramhour/milliliter (ngh/mL)
	3230 (59%)	1820 (56%)

5.Secondary Outcome


Title	Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Description	ORR was the percentage of participants achieving a best overall respon...
Description	ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions.
Time Frame	Randomization to Second Measured Complete Response or Partial Response (Up To 34 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug in Part B. Per protocol, this analysis was planned for Part B only.


Arm/Group Title	Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD	Part B: Placebo + 160 mg Enzalutamide QD
Arm/Group Description:	Participants received 200 mg LY3023...	Participants received placebo in co...
Arm/Group Description:	Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).	Participants received placebo in combination with 160 mg enzalutamide orally QD.
Overall Number of Participants Analyzed	65	64
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	4.6 (1.0 to 12.9)	4.6 (1.0 to 13.1)

Adverse Events

Time Frame	Baseline Up To 5 Years
Adverse Event Reporting Description	All participants who received at least one dose of study drug.

Arm/Group Title	Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD		Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD		Part B: Placebo + 160 mg Enzalutamide QD
Arm/Group Description	Participants received 200 mg LY3023...		Participants received 200 mg LY3023...		Participants received placebo in co...
Arm/Group Description	Participants received 200 mg LY3023414 orally every 12 hours (BID) during initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide orally QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days.		Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).		Participants received placebo in combination with 160 mg enzalutamide orally QD.
All-Cause Mortality
	Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD		Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD		Part B: Placebo + 160 mg Enzalutamide QD
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	1/13 (7.69%)		0/65 (0.00%)		3/64 (4.69%)
Serious Adverse Events Serious Adverse Events
	Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD		Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD		Part B: Placebo + 160 mg Enzalutamide QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/13 (38.46%)		13/65 (20.00%)		12/64 (18.75%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	1/64 (1.56%)	1
Blood loss anaemia ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Febrile neutropenia ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Cardiac disorders
Atrial fibrillation ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	2/64 (3.13%)	2
Myocardial ischaemia ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Gastrointestinal disorders
Abdominal pain lower ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Constipation ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	2/64 (3.13%)	2
Diverticulum intestinal ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Nausea ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Obstructive pancreatitis ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Small intestinal obstruction ^† 1	0/13 (0.00%)	0	2/65 (3.08%)	2	0/64 (0.00%)	0
Vomiting ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
General disorders
Asthenia ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Chest pain ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Pyrexia ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Hepatobiliary disorders
Cholecystitis acute ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Hepatic cirrhosis ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Infections and infestations
Bacterial sepsis ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Cystitis ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	1/64 (1.56%)	1
Pneumonia ^† 1	0/13 (0.00%)	0	3/65 (4.62%)	3	1/64 (1.56%)	1
Pneumonia bacterial ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Postoperative wound infection ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Sepsis ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	1/64 (1.56%)	1
Tooth abscess ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Urinary tract infection ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Viral infection ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Injury, poisoning and procedural complications
Contusion ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Fall ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Investigations
Troponin i increased ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/13 (0.00%)	0	2/65 (3.08%)	2	0/64 (0.00%)	0
Osteonecrosis ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Nervous system disorders
Haemorrhage intracranial ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	1/64 (1.56%)	1
Syncope ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	2	0/64 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Haematuria ^† 1	0/13 (0.00%)	0	0/65 (0.00%)	0	2/64 (3.13%)	2
Urethral obstruction ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Urinary retention ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Pulmonary embolism ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
Vascular disorders
Deep vein thrombosis ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	0/64 (0.00%)	0
1 Term from vocabulary, MedDRA 23.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD		Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD		Part B: Placebo + 160 mg Enzalutamide QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/13 (100.00%)		64/65 (98.46%)		63/64 (98.44%)
Blood and lymphatic system disorders
Anaemia ^† 1	2/13 (15.38%)	3	11/65 (16.92%)	29	18/64 (28.13%)	34
Febrile neutropenia ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Leukopenia ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Pancytopenia ^† 1	1/13 (7.69%)	2	0/65 (0.00%)	0	1/64 (1.56%)	1
Thrombocytopenia ^† 1	1/13 (7.69%)	2	2/65 (3.08%)	2	1/64 (1.56%)	2
Ear and labyrinth disorders
Ear discomfort ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Tinnitus ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Vertigo ^† 1	1/13 (7.69%)	2	1/65 (1.54%)	1	2/64 (3.13%)	3
Eye disorders
Dry eye ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Eye pain ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Ocular hypertension ^† 1	2/13 (15.38%)	2	0/65 (0.00%)	0	0/64 (0.00%)	0
Ocular rosacea ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Retinal detachment ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Scleritis ^† 1	1/13 (7.69%)	3	0/65 (0.00%)	0	0/64 (0.00%)	0
Vision blurred ^† 1	3/13 (23.08%)	5	1/65 (1.54%)	1	2/64 (3.13%)	2
Gastrointestinal disorders
Abdominal pain ^† 1	0/13 (0.00%)	0	4/65 (6.15%)	5	6/64 (9.38%)	7
Abdominal pain lower ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	1/64 (1.56%)	1
Abdominal pain upper ^† 1	2/13 (15.38%)	2	1/65 (1.54%)	1	3/64 (4.69%)	3
Anal incontinence ^† 1	2/13 (15.38%)	2	0/65 (0.00%)	0	0/64 (0.00%)	0
Cheilitis ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Constipation ^† 1	2/13 (15.38%)	3	11/65 (16.92%)	12	12/64 (18.75%)	15
Diarrhoea ^† 1	7/13 (53.85%)	17	40/65 (61.54%)	68	10/64 (15.63%)	12
Dyspepsia ^† 1	0/13 (0.00%)	0	7/65 (10.77%)	7	4/64 (6.25%)	4
Dysphagia ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Gastrooesophageal reflux disease ^† 1	1/13 (7.69%)	2	4/65 (6.15%)	5	0/64 (0.00%)	0
Haematochezia ^† 1	1/13 (7.69%)	1	2/65 (3.08%)	2	0/64 (0.00%)	0
Nausea ^† 1	9/13 (69.23%)	10	38/65 (58.46%)	58	25/64 (39.06%)	32
Oral disorder ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Paraesthesia oral ^† 1	3/13 (23.08%)	3	3/65 (4.62%)	5	0/64 (0.00%)	0
Stomatitis ^† 1	0/13 (0.00%)	0	9/65 (13.85%)	10	0/64 (0.00%)	0
Tongue ulceration ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Vomiting ^† 1	6/13 (46.15%)	12	18/65 (27.69%)	24	6/64 (9.38%)	12
General disorders
Asthenia ^† 1	3/13 (23.08%)	4	8/65 (12.31%)	9	4/64 (6.25%)	4
Chest discomfort ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	1/64 (1.56%)	1
Chest pain ^† 1	3/13 (23.08%)	5	1/65 (1.54%)	1	2/64 (3.13%)	2
Chills ^† 1	2/13 (15.38%)	2	5/65 (7.69%)	5	2/64 (3.13%)	2
Face oedema ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Fatigue ^† 1	7/13 (53.85%)	11	41/65 (63.08%)	64	36/64 (56.25%)	45
Influenza like illness ^† 1	1/13 (7.69%)	1	2/65 (3.08%)	2	1/64 (1.56%)	1
Mucosal inflammation ^† 1	1/13 (7.69%)	1	3/65 (4.62%)	5	0/64 (0.00%)	0
Oedema ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Oedema peripheral ^† 1	2/13 (15.38%)	3	7/65 (10.77%)	7	5/64 (7.81%)	6
Pain ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	3/64 (4.69%)	5
Systemic inflammatory response syndrome ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Unevaluable event ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Infections and infestations
Conjunctivitis ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Cystitis ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Herpes zoster ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	2	0/64 (0.00%)	0
Nasopharyngitis ^† 1	1/13 (7.69%)	1	3/65 (4.62%)	4	3/64 (4.69%)	4
Pneumonia ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	1/64 (1.56%)	1
Skin infection ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Upper respiratory tract infection ^† 1	2/13 (15.38%)	2	2/65 (3.08%)	2	3/64 (4.69%)	4
Urinary tract infection ^† 1	3/13 (23.08%)	4	6/65 (9.23%)	10	6/64 (9.38%)	7
Injury, poisoning and procedural complications
Fall ^† 1	1/13 (7.69%)	1	5/65 (7.69%)	8	5/64 (7.81%)	7
Investigations
Alanine aminotransferase increased ^† 1	1/13 (7.69%)	2	1/65 (1.54%)	1	1/64 (1.56%)	1
Aspartate aminotransferase increased ^† 1	1/13 (7.69%)	1	3/65 (4.62%)	4	1/64 (1.56%)	2
Blood creatinine increased ^† 1	1/13 (7.69%)	2	5/65 (7.69%)	8	2/64 (3.13%)	2
Blood lactate dehydrogenase increased ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Blood lactic acid increased ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Blood potassium increased ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Creatinine renal clearance ^† 1	1/13 (7.69%)	2	0/65 (0.00%)	0	0/64 (0.00%)	0
Haematocrit decreased ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Haemoglobin decreased ^† 1	2/13 (15.38%)	2	0/65 (0.00%)	0	1/64 (1.56%)	1
Red blood cell count decreased ^† 1	2/13 (15.38%)	2	0/65 (0.00%)	0	1/64 (1.56%)	1
Weight decreased ^† 1	3/13 (23.08%)	3	11/65 (16.92%)	17	5/64 (7.81%)	6
Metabolism and nutrition disorders
Decreased appetite ^† 1	5/13 (38.46%)	6	20/65 (30.77%)	25	14/64 (21.88%)	14
Dehydration ^† 1	2/13 (15.38%)	3	8/65 (12.31%)	9	1/64 (1.56%)	1
Diabetes mellitus ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Hyperglycaemia ^† 1	1/13 (7.69%)	1	6/65 (9.23%)	6	6/64 (9.38%)	9
Hypocalcaemia ^† 1	1/13 (7.69%)	1	2/65 (3.08%)	2	2/64 (3.13%)	3
Hypochloraemia ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	1/64 (1.56%)	1
Hypoglycaemia ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Hypokalaemia ^† 1	1/13 (7.69%)	1	6/65 (9.23%)	10	4/64 (6.25%)	4
Hypophosphataemia ^† 1	0/13 (0.00%)	0	5/65 (7.69%)	5	2/64 (3.13%)	3
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/13 (7.69%)	3	9/65 (13.85%)	12	18/64 (28.13%)	24
Back pain ^† 1	1/13 (7.69%)	1	14/65 (21.54%)	19	17/64 (26.56%)	26
Bone pain ^† 1	0/13 (0.00%)	0	2/65 (3.08%)	2	6/64 (9.38%)	7
Flank pain ^† 1	1/13 (7.69%)	1	2/65 (3.08%)	2	3/64 (4.69%)	3
Muscular weakness ^† 1	2/13 (15.38%)	3	7/65 (10.77%)	7	9/64 (14.06%)	10
Musculoskeletal chest pain ^† 1	1/13 (7.69%)	1	4/65 (6.15%)	6	2/64 (3.13%)	2
Musculoskeletal pain ^† 1	0/13 (0.00%)	0	7/65 (10.77%)	7	6/64 (9.38%)	6
Pain in extremity ^† 1	1/13 (7.69%)	3	7/65 (10.77%)	7	8/64 (12.50%)	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Nervous system disorders
Aphasia ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Cognitive disorder ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Dizziness ^† 1	4/13 (30.77%)	4	12/65 (18.46%)	13	6/64 (9.38%)	8
Drooling ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Dysgeusia ^† 1	1/13 (7.69%)	1	9/65 (13.85%)	9	5/64 (7.81%)	5
Headache ^† 1	4/13 (30.77%)	6	3/65 (4.62%)	4	5/64 (7.81%)	5
Hypoaesthesia ^† 1	1/13 (7.69%)	1	3/65 (4.62%)	3	0/64 (0.00%)	0
Peripheral motor neuropathy ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Syncope ^† 1	0/13 (0.00%)	0	4/65 (6.15%)	4	0/64 (0.00%)	0
Taste disorder ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	1/64 (1.56%)	2
Tremor ^† 1	1/13 (7.69%)	1	6/65 (9.23%)	6	0/64 (0.00%)	0
Psychiatric disorders
Anxiety ^† 1	0/13 (0.00%)	0	1/65 (1.54%)	1	4/64 (6.25%)	4
Depression ^† 1	2/13 (15.38%)	2	2/65 (3.08%)	2	6/64 (9.38%)	7
Insomnia ^† 1	2/13 (15.38%)	2	4/65 (6.15%)	4	4/64 (6.25%)	4
Renal and urinary disorders
Acute kidney injury ^† 1	2/13 (15.38%)	2	2/65 (3.08%)	3	1/64 (1.56%)	1
Haematuria ^† 1	2/13 (15.38%)	3	5/65 (7.69%)	9	5/64 (7.81%)	5
Proteinuria ^† 1	0/13 (0.00%)	0	6/65 (9.23%)	14	0/64 (0.00%)	0
Urinary incontinence ^† 1	1/13 (7.69%)	1	2/65 (3.08%)	2	3/64 (4.69%)	4
Urinary retention ^† 1	1/13 (7.69%)	1	2/65 (3.08%)	3	1/64 (1.56%)	1
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	0/13 (0.00%)	0	5/65 (7.69%)	5	5/64 (7.81%)	5
Dyspnoea ^† 1	3/13 (23.08%)	5	5/65 (7.69%)	5	4/64 (6.25%)	7
Epistaxis ^† 1	1/13 (7.69%)	1	3/65 (4.62%)	3	0/64 (0.00%)	0
Oropharyngeal pain ^† 1	0/13 (0.00%)	0	4/65 (6.15%)	6	2/64 (3.13%)	2
Pleurisy ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Rhinorrhoea ^† 1	2/13 (15.38%)	2	1/65 (1.54%)	1	0/64 (0.00%)	0
Skin and subcutaneous tissue disorders
Alopecia ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Eczema ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Pruritus ^† 1	1/13 (7.69%)	2	4/65 (6.15%)	4	0/64 (0.00%)	0
Rash ^† 1	1/13 (7.69%)	1	8/65 (12.31%)	9	4/64 (6.25%)	4
Rash maculo-papular ^† 1	0/13 (0.00%)	0	4/65 (6.15%)	5	1/64 (1.56%)	1
Skin maceration ^† 1	1/13 (7.69%)	1	0/65 (0.00%)	0	0/64 (0.00%)	0
Vascular disorders
Deep vein thrombosis ^† 1	1/13 (7.69%)	1	1/65 (1.54%)	1	0/64 (0.00%)	0
Hot flush ^† 1	0/13 (0.00%)	0	6/65 (9.23%)	6	5/64 (7.81%)	5
Hypertension ^† 1	0/13 (0.00%)	0	6/65 (9.23%)	8	8/64 (12.50%)	21
1 Term from vocabulary, MedDRA 23.0 † Indicates events were collected by 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.

Results Point of Contact

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Name/Title:	Chief Medical Officer
Organization:	Eli Lilly and Company
Phone:	800-545-5979
EMail:	ClinicalTrials.gov@lilly.com

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

Sweeney CJ, Percent IJ, Babu S, Cultrera JL, Mehlhaff BA, Goodman OB, Morris DS, Schnadig ID, Albany C, Shore ND, Sieber PR, Guba SC, Zhang W, Wacheck V, Donoho GP, Szpurka AM, Callies S, Lin BK, Bendell JC. Phase Ib/II Study of Enzalutamide with Samotolisib (LY3023414) or Placebo in Patients with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2022 Jun 1;28(11):2237-2247. doi: 10.1158/1078-0432.CCR-21-2326.

Layout table for additonal information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT02407054
Other Study ID Numbers:	15798 I6A-MC-CBBD ( Other Identifier: Eli Lilly and Company )
First Submitted:	March 30, 2015
First Posted:	April 2, 2015
Results First Submitted:	April 17, 2021
Results First Posted:	May 11, 2021
Last Update Posted:	May 11, 2021

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