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A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)

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ClinicalTrials.gov Identifier: NCT03992131
Recruitment Status : Terminated (Due to a change in development priorities, no further clinical development of the lucitanib plus rucaparib or lucitanib plus sacituzumab govitecan combinations is planned at this time.)
First Posted : June 20, 2019
Results First Posted : January 16, 2024
Last Update Posted : January 16, 2024
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
pharmaand GmbH

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Triple-negative Breast Cancer
Urothelial Carcinoma
Solid Tumor
Interventions Drug: Rucaparib
Drug: Lucitanib
Drug: Sacituzumab govitecan
Enrollment 25
Recruitment Details  
Pre-assignment Details The study was planned to be conducted in 2 phases: Phase 1b and Phase 2. Enrollment was terminated before Phase 1b was complete, due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan. Hence, Phase 2 portion of the study was not conducted.
Arm/Group Title Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Hide Arm/Group Description Participants received oral rucaparib 300 milligrams (mg) twice daily (BID) and oral lucitanib 4 mg once daily (QD) continuously in 28-day cycles. Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. Participants received oral rucaparib 300 mg BID, administered continuously, in combination with intravenous (IV) sacituzumab govitecan 6 mg/kilogram (kg) administration on Day 1 and Day 8 of a 21-day cycle. Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Period Title: Overall Study
Started 6 4 3 6 3 3
Received at Least 1 Dose of Study Drug 6 4 3 6 3 3
Completed 6 4 3 6 3 3
Not Completed 0 0 0 0 0 0
Arm/Group Title Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan Total
Hide Arm/Group Description Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 6 4 3 6 3 3 25
Hide Baseline Analysis Population Description
Safety population included all participants who have received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 3 participants 6 participants 3 participants 3 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  50.0%
3
  75.0%
0
   0.0%
6
 100.0%
3
 100.0%
2
  66.7%
17
  68.0%
>=65 years
3
  50.0%
1
  25.0%
3
 100.0%
0
   0.0%
0
   0.0%
1
  33.3%
8
  32.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 3 participants 6 participants 3 participants 3 participants 25 participants
Female
5
  83.3%
2
  50.0%
2
  66.7%
5
  83.3%
2
  66.7%
3
 100.0%
19
  76.0%
Male
1
  16.7%
2
  50.0%
1
  33.3%
1
  16.7%
1
  33.3%
0
   0.0%
6
  24.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 3 participants 6 participants 3 participants 3 participants 25 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  33.3%
2
  33.3%
0
   0.0%
0
   0.0%
3
  12.0%
Not Hispanic or Latino
5
  83.3%
4
 100.0%
2
  66.7%
4
  66.7%
3
 100.0%
3
 100.0%
21
  84.0%
Unknown or Not Reported
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 3 participants 6 participants 3 participants 3 participants 25 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%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
   4.0%
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%
Black or African American
1
  16.7%
1
  25.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
3
  12.0%
White
5
  83.3%
3
  75.0%
2
  66.7%
4
  66.7%
2
  66.7%
3
 100.0%
19
  76.0%
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%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  33.3%
1
  16.7%
0
   0.0%
0
   0.0%
2
   8.0%
1.Primary Outcome
Title Number of Participants With Objective Response, as Assessed by the Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 (Phase 2)
Hide Description Objective response was defined as a documented and confirmed best overall response of complete response (CR) or partial response (PR) as assessed by the investigator. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeters (mm); and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan, the study was terminated before Phase 1b was complete, and Phase 2 portion of the study was not conducted. Hence, the data for this outcome measure could not be collected and analyzed.
Arm/Group Title Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Hide Arm/Group Description:
Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Response (DOR) (Phase 2)
Hide Description Duration of response was measured from the date that best response (CR or PR) was first recorded until the first date that disease progression was documented per RECIST v1.1. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm; and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression.
Time Frame From the date of first best response to disease progression or death, whichever occurs first, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan, the study was terminated before Phase 1b was complete, and Phase 2 portion of the study was not conducted. Hence, the data for this outcome measure could not be collected and analyzed.
Arm/Group Title Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Hide Arm/Group Description:
Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival (PFS) (Phase 2)
Hide Description PFS was measured as the 1+ the number of days from the first dose of study drug to documented radiographic progression, according to RECIST v1.1, as determined by the investigator, or death due to any cause, whichever occurred first. Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression.
Time Frame From the first dose of study drug to documented radiographic progression or death, whichever occurs first, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan, the study was terminated before Phase 1b was complete, and Phase 2 portion of the study was not conducted. Hence, the data for this outcome measure could not be collected and analyzed.
Arm/Group Title Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Hide Arm/Group Description:
Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b)
Hide Description Objective response was defined as a documented and confirmed best overall response of CR or PR as assessed by the investigator. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm; and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time Frame From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants who had received at least 1 dose of rucaparib or the second study drug and who had measurable disease per RECIST v1.1 at baseline.
Arm/Group Title Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Hide Arm/Group Description:
Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.
Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
Overall Number of Participants Analyzed 6 4 3 6 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
2
  66.7%
Time Frame From the first dose of study drug up to 2 years
Adverse Event Reporting Description Safety population included all participants who have received at least 1 dose of study drug.
 
Arm/Group Title Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Hide Arm/Group Description Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.
All-Cause Mortality
Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/4 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/3 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   0/4 (0.00%)   0/3 (0.00%)   2/6 (33.33%)   2/3 (66.67%)   1/3 (33.33%) 
Blood and lymphatic system disorders             
Anaemia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Febrile neutropenia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders             
Constipation † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Small intestinal obstruction † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Hepatobiliary disorders             
Cholecystitis † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Infections and infestations             
Appendicitis † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cellulitis † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Clostridium difficile infection † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Investigations             
Alanine aminotransferase increased † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Aspartate aminotransferase increased † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Blood creatinine increased † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders             
Muscular weakness † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Renal and urinary disorders             
Hydronephrosis † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pleural effusion † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   4/4 (100.00%)   3/3 (100.00%)   6/6 (100.00%)   3/3 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  2/6 (33.33%)  2/4 (50.00%)  0/3 (0.00%)  3/6 (50.00%)  1/3 (33.33%)  1/3 (33.33%) 
Iron deficiency anaemia † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neutropenia † 1  1/6 (16.67%)  1/4 (25.00%)  1/3 (33.33%)  2/6 (33.33%)  2/3 (66.67%)  2/3 (66.67%) 
Thrombocytopenia † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Leukopenia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Cardiac disorders             
Palpitations † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Ear and labyrinth disorders             
Ear pain † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Endocrine disorders             
Hypothyroidism † 1  0/6 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders             
Abdominal distension † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Abdominal pain † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  2/3 (66.67%)  0/3 (0.00%) 
Abdominal pain lower † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Ascites † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Constipation † 1  1/6 (16.67%)  1/4 (25.00%)  2/3 (66.67%)  1/6 (16.67%)  1/3 (33.33%)  1/3 (33.33%) 
Diarrhoea † 1  2/6 (33.33%)  0/4 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  2/3 (66.67%)  3/3 (100.00%) 
Gastrooesophageal reflux disease † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Intestinal obstruction † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Nausea † 1  3/6 (50.00%)  2/4 (50.00%)  2/3 (66.67%)  2/6 (33.33%)  1/3 (33.33%)  2/3 (66.67%) 
Toothache † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Vomiting † 1  1/6 (16.67%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/3 (33.33%)  2/3 (66.67%) 
Dysphagia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Proctalgia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Stomatitis † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
General disorders             
Asthenia † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Axillary pain † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Catheter site erythema † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Fatigue † 1  1/6 (16.67%)  1/4 (25.00%)  1/3 (33.33%)  1/6 (16.67%)  2/3 (66.67%)  2/3 (66.67%) 
Mucosal inflammation † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Nodule † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Non-cardiac chest pain † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Oedema peripheral † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Swelling face † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Influenza like illness † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Swelling † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Immune system disorders             
Seasonal allergy † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Infections and infestations             
COVID-19 † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Tooth infection † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Upper respiratory tract infection † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Urinary tract infection † 1  1/6 (16.67%)  0/4 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Eye infection † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Oral candidiasis † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Otitis media † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Sinusitis † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Injury, poisoning and procedural complications             
Ankle fracture † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Fall † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Investigations             
Alanine aminotransferase increased † 1  3/6 (50.00%)  2/4 (50.00%)  1/3 (33.33%)  2/6 (33.33%)  2/3 (66.67%)  2/3 (66.67%) 
Aspartate aminotransferase increased † 1  3/6 (50.00%)  2/4 (50.00%)  1/3 (33.33%)  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%) 
Blood alkaline phosphatase increased † 1  1/6 (16.67%)  0/4 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Blood bilirubin increased † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Blood creatinine increased † 1  2/6 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  2/6 (33.33%)  0/3 (0.00%)  1/3 (33.33%) 
Blood lactate dehydrogenase increased † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Blood thyroid stimulating hormone increased † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Lymphocyte count decreased † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neutrophil count decreased † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Platelet count decreased † 1  1/6 (16.67%)  1/4 (25.00%)  0/3 (0.00%)  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%) 
Prostatic specific antigen increased † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Transaminases increased † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Urine output decreased † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Weight decreased † 1  2/6 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
White blood cell count decreased † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Activated partial thromboplastin time prolonged † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Blood bicarbonate decreased † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Electrocardiogram abnormal † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Neutrophil count decreased † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Metabolism and nutrition disorders             
Decreased appetite † 1  2/6 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Dehydration † 1  1/6 (16.67%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Hypercalcaemia † 1  0/6 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Hypercholesterolaemia † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hyperkalaemia † 1  2/6 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hyperlipidaemia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Hyperphosphataemia † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hypokalaemia † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%) 
Hypomagnesaemia † 1  2/6 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  1/3 (33.33%) 
Hyponatraemia † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  2/3 (66.67%)  1/3 (33.33%) 
Hypophosphataemia † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  1/3 (33.33%) 
Lactic acidosis † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hyperglycaemia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypoalbuminaemia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypoglycaemia † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Type 2 diabetes mellitus † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Vitamin D deficiency † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Zinc deficiency † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Back pain † 1  0/6 (0.00%)  2/4 (50.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Muscle spasms † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Muscular weakness † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Musculoskeletal chest pain † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Myalgia † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neck pain † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Osteoporosis † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Bone pain † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Flank pain † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Cancer pain † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Nervous system disorders             
Dizziness † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Dysgeusia † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Headache † 1  2/6 (33.33%)  0/4 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  0/3 (0.00%)  1/3 (33.33%) 
Peripheral sensory neuropathy † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Taste disorder † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neuropathy peripheral † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Depression † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Psychiatric disorders             
Anxiety † 1  1/6 (16.67%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Insomnia † 1  2/6 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Depression † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Renal and urinary disorders             
Acute kidney injury † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Haematuria † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Proteinuria † 1  3/6 (50.00%)  0/4 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders             
Breast pain † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Breast swelling † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Breast tenderness † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Vulvovaginal dryness † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough † 1  2/6 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Dyspnoea † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  2/3 (66.67%) 
Dyspnoea exertional † 1  1/6 (16.67%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hiccups † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Pleural effusion † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Rhinitis allergic † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders             
Alopecia † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  2/3 (66.67%)  0/3 (0.00%) 
Dry skin † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Pruritus † 1  0/6 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/6 (0.00%)  2/3 (66.67%)  0/3 (0.00%) 
Rash † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Rash maculo-papular † 1  0/6 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Vascular disorders             
Flushing † 1  0/6 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hypertension † 1  3/6 (50.00%)  2/4 (50.00%)  2/3 (66.67%)  4/6 (66.67%)  0/3 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
The study was terminated due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan.
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.
Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Department
Organization: pharmaand GmbH
Phone: +43/1/3560006
EMail: medinfo@pharmaand.com
Layout table for additonal information
Responsible Party: pharmaand GmbH
ClinicalTrials.gov Identifier: NCT03992131    
Other Study ID Numbers: CO-338-098
2018-003759-39 ( EudraCT Number )
First Submitted: June 4, 2019
First Posted: June 20, 2019
Results First Submitted: December 4, 2023
Results First Posted: January 16, 2024
Last Update Posted: January 16, 2024