Trial Outcomes & Findings for PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (NCT NCT04556617)
NCT ID: NCT04556617
Last Updated: 2025-04-08
Results Overview
Dose limiting toxicity defined as clinically significant adverse events or laboratory abnormalities occurring during first cycle of study drug administration that are possibly related to study drug and that meet specific criteria defined in the protocol
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
Dose escalation
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
Dose escalation Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
Dose escalation Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
Dose expansion Once daily dosing PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
Dose escalation Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
5
|
7
|
5
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
7
|
5
|
1
|
Reasons for withdrawal
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
Dose escalation
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
Dose escalation Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
Dose escalation Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
Dose expansion Once daily dosing PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
Dose escalation Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
|---|---|---|---|---|---|
|
Overall Study
progressive disease
|
0
|
2
|
2
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study
PSA increase
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor study termination
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Baseline characteristics by cohort
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
n=1 Participants
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=7 Participants
Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
n=1 Participants
Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=93 Participants
|
66.4 years
n=4 Participants
|
68.9 years
n=27 Participants
|
68.2 years
n=483 Participants
|
73 years
n=36 Participants
|
68.3 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
5 participants
n=4 Participants
|
7 participants
n=27 Participants
|
5 participants
n=483 Participants
|
1 participants
n=36 Participants
|
19 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)Dose limiting toxicity defined as clinically significant adverse events or laboratory abnormalities occurring during first cycle of study drug administration that are possibly related to study drug and that meet specific criteria defined in the protocol
Outcome measures
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
n=1 Participants
Dose escalation
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Dose escalation Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=7 Participants
Dose escalation Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Dose expansion Once daily dosing PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
n=1 Participants
Dose escalation Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From time of first dose of PLX2853 and combination agent(s) until 30 days from end of treatment (an average of 103 days)Treatment-emergent adverse events are those reported after study drug has been administered.
Outcome measures
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
n=1 Participants
Dose escalation
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Dose escalation Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=7 Participants
Dose escalation Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Dose expansion Once daily dosing PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
n=1 Participants
Dose escalation Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
|---|---|---|---|---|---|
|
Phase 1b (Both Arms): Incidence of TEAEs That Are Related to Treatment
|
1 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)To be evaluated in both PLX2853 + AA + pred and PLX2853 + olap group; If DLTs observed in 2 or more subjects the dose will be considered intolerable and MTD will have been reached.
Outcome measures
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
n=1 Participants
Dose escalation
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Dose escalation Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=7 Participants
Dose escalation Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=5 Participants
Dose expansion Once daily dosing PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
n=1 Participants
Dose escalation Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
|---|---|---|---|---|---|
|
Determination of Maximum Tolerated Dose
|
NA mg
Study terminated and MTD not determined as DLTs not observed in 2 subjects or more per protocol definition
|
NA mg
Study terminated and MTD not determined as DLTs not observed in 2 subjects or more per protocol definition
|
NA mg
Study terminated and MTD not determined as DLTs not observed in 2 subjects or more per protocol definition
|
NA mg
Study terminated and MTD not determined as DLTs not observed in 2 subjects or more per protocol definition
|
NA mg
Study terminated and MTD not determined as DLTs not observed in 2 subjects or more per protocol definition
|
Adverse Events
Phase 1b PLX2853 (20 mg) + Olaparib
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b PLX2853 (40 mg) + Olaparib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
n=1 participants at risk
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
n=5 participants at risk
Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=7 participants at risk
Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=5 participants at risk
Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
n=1 participants at risk
Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Infections and infestations
Blood bilirubin increase
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
Other adverse events
| Measure |
Phase 1b PLX2853 (20 mg) + Olaparib
n=1 participants at risk
Once daily dosing PLX2853 20 mg
Twice daily dosing olap 300 mg
|
Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
n=5 participants at risk
Once daily dosing of PLX2853 40 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=7 participants at risk
Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
n=5 participants at risk
Once daily dosing of PLX2853 80 mg AA 1000 mg pred 10 mg
|
Phase 1b PLX2853 (40 mg) + Olaparib
n=1 participants at risk
Once daily dosing PLX2853 40 mg
Twice daily dosing olap 300 mg
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
71.4%
5/7 • Number of events 5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
|
Blood and lymphatic system disorders
pancytopenia
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
100.0%
5/5 • Number of events 7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
nausea
|
100.0%
1/1 • Number of events 4 • Through 30 days after last study drug, an average of 6 months
|
80.0%
4/5 • Number of events 4 • Through 30 days after last study drug, an average of 6 months
|
100.0%
7/7 • Number of events 7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
|
Renal and urinary disorders
urinary tract infection
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
28.6%
2/7 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
anorexia
|
100.0%
1/1 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
28.6%
2/7 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Eye disorders
blurred vision
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
80.0%
4/5 • Number of events 4 • Through 30 days after last study drug, an average of 6 months
|
28.6%
2/7 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
60.0%
3/5 • Number of events 3 • Through 30 days after last study drug, an average of 6 months
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
60.0%
3/5 • Number of events 3 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
dry heaving
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
General disorders
fatigue
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
60.0%
3/5 • Number of events 3 • Through 30 days after last study drug, an average of 6 months
|
85.7%
6/7 • Number of events 6 • Through 30 days after last study drug, an average of 6 months
|
100.0%
5/5 • Number of events 7 • Through 30 days after last study drug, an average of 6 months
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
|
General disorders
unsteady gait
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
amylase increased
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
bilirubin increased
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
creatinine increased
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
elevated d-dimer
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
platelet count decreased
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Investigations
weight loss
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
85.7%
6/7 • Number of events 6 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Nervous system disorders
dizziness
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
28.6%
2/7 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
28.6%
2/7 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Nervous system disorders
headache
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
40.0%
2/5 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Nervous system disorders
tremors
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
intermittent hyperhydrosis
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
40.0%
2/5 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
General disorders
edema limbs
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Infections and infestations
herpes simplex reactivation
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
57.1%
4/7 • Number of events 4 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
low appetite
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
28.6%
2/7 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
100.0%
1/1 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
28.6%
2/7 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
57.1%
4/7 • Number of events 4 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Renal and urinary disorders
urinary tract obstruction
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
14.3%
1/7 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
40.0%
2/5 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
40.0%
2/5 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
100.0%
1/1 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
|
General disorders
chills
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
General disorders
fever
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Infections and infestations
shingles
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
80.0%
4/5 • Number of events 4 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Renal and urinary disorders
dysuria
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
40.0%
2/5 • Number of events 2 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
itchy skin
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
20.0%
1/5 • Number of events 1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
60.0%
3/5 • Number of events 3 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
|
Vascular disorders
worsening hypertension
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/7 • Through 30 days after last study drug, an average of 6 months
|
100.0%
5/5 • Number of events 5 • Through 30 days after last study drug, an average of 6 months
|
0.00%
0/1 • Through 30 days after last study drug, an average of 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place