Trial Outcomes & Findings for ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer (NCT NCT03480646)
NCT ID: NCT03480646
Last Updated: 2025-10-29
Results Overview
Best overall response rate (%) defined as complete response (CR) + partial response (PR) divided by the total number of subjects as assessed by Investigator. The response assessment was performed per Prostate Cancer Working Group 3 (PCWG3) based on modifications of the RECIST 1.1 criteria. Per RECIST 1.1, a CR was assessed when all target lesions disappeared (any pathological lymph node must have reduction in short axis to \<10 mm) in the post-baseline scan. A PR was assessed when there was at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
175 participants
Primary outcome timeframe
Up to 2 years [or until disease progression or unacceptable toxicity]
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Enza
CPI-1205 400 mg BID in combination with Cobicistat 500 mg PO BID and Enzalutamide 160 mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Abi/Pred
CPI-1205 400 mg BID in combination with Cobicistat 150 mg PO BID and Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Enza
CPI-1205 800 mg TID in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Abi/Pred
CPI-1205 800 mg TID in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles) Prednisone: Prednisone 5mg PO BID
|
Phase 1b HPEC: CPI-1205 800 mg TID Heavily Pre-treated Expansion Cohort + Enza
CPI-1205 800 mg TID in heavily pretreated expansion cohort in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Controlled: Enza
Controlled group of Phase 2 randomized: Enzalutamide 160 mg PO QD
|
Phase 2 Randomized Experimental: CPI-1205 at RP2D + Enza
CPI-1205 800 mg TID (RP2D) in combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm: CPI-1205 (at RP2D) +Abi/Pred
CPI-1205 800 mg TID (RP2D) in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
9
|
13
|
32
|
35
|
39
|
32
|
|
Overall Study
Phase 2: Crossover From Enza to CPI-1205 800mg TID + Enza
|
0
|
0
|
0
|
0
|
0
|
12
|
0
|
0
|
|
Overall Study
Safety Analysis Set (SAF)
|
7
|
8
|
9
|
12
|
31
|
35
|
39
|
32
|
|
Overall Study
Full Analysis Set (FAS)
|
7
|
8
|
9
|
12
|
31
|
35
|
39
|
32
|
|
Overall Study
Efficacy Analysis Set (EAS)
|
5
|
7
|
9
|
11
|
25
|
35
|
38
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
9
|
13
|
32
|
35
|
39
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b Dose Escalation: CPI-1205 400 mg BID +Cobi + Enza
n=7 Participants
CPI-1205 400 mg BID in combination with Cobicistat 150mg PO BID and Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Abi/Pred
n=8 Participants
CPI-1205 400 mg BID in combination iwth Cobicistat 150 mg PO BID and Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Enza
n=9 Participants
CPI-1205 800 mg TID in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Abi/Pred
n=12 Participants
CPI-1205 800 mg TID in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Phase 1b HPEC: CPI-1205 800 mg TID Heavily Pretreated Expansion Cohort + Enza
n=31 Participants
CPI-1205 800 mg TID in heavily pretreated expansion cohort in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Controlled: Enza
n=35 Participants
Control group of Phase 2 randomized: Enzalutamide 160 mg PO QD
|
Phase 2 Randomized Experimental: CPI-1205 at RP2D + Enza
n=39 Participants
CPI-1205 800 mg TID (RP2D) in combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm: CPI-1205 at RP2D + Abi/Pred
n=32 Participants
CPI-1205 800 mg TID (RP2D) in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Prior cancer hormonal Therapy
No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Prior cancer chemotherapy
Yes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
68 Participants
n=42 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
50 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
123 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
173 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
123 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Prior cancer Immunotherapy
Yes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
58 Participants
n=42 Participants
|
|
Prior cancer Immunotherapy
No
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
115 Participants
n=42 Participants
|
|
Prior cancer hormonal Therapy
Yes
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
172 Participants
n=42 Participants
|
|
Prior cancer chemotherapy
No
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
105 Participants
n=42 Participants
|
|
Prior radiation therapy
Yes
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
125 Participants
n=42 Participants
|
|
Prior radiation therapy
No
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years [or until disease progression or unacceptable toxicity]Population: Efficacy Analysis Set: subjects with a baseline measurement of response and at least 1 timepoint after baseline
Best overall response rate (%) defined as complete response (CR) + partial response (PR) divided by the total number of subjects as assessed by Investigator. The response assessment was performed per Prostate Cancer Working Group 3 (PCWG3) based on modifications of the RECIST 1.1 criteria. Per RECIST 1.1, a CR was assessed when all target lesions disappeared (any pathological lymph node must have reduction in short axis to \<10 mm) in the post-baseline scan. A PR was assessed when there was at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1b HPEC [Heavily Pre-treated Expansion Cohort] CPI-1205 800mg TID +Enza
n=25 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Enza Contro
n=35 Participants
Enzalutamide Control Drug: Enzalutamide 160mg PO QD (28-day cycles) Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Combination With Enza
n=38 Participants
CPI-1205 (at RP2D) Combination with Enzalutamide Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Enzalutamide 160mg PO QD CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Crossover Period
n=12 Participants
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm CPI-1205 +Abi/Pred
n=28 Participants
CPI-1205 (at RP2D) Combination with Abiraterone/Prednisone Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Abiraterone 1000mg PO QD and Prednisone 5mg PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Enza
n=5 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Abi/Pred
n=7 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Enza
n=9 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Abi/Pred
n=11 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
|---|---|---|---|---|---|---|---|---|---|
|
Efficacy: Best Objective Response Rate Percent by Treatment Group
|
8.00 Percent (%) of subjects
Interval 0.98 to 26.03
|
5.71 Percent (%) of subjects
Interval 0.7 to 19.16
|
7.89 Percent (%) of subjects
Interval 1.66 to 21.38
|
0 Percent (%) of subjects
Interval 0.0 to 26.46
|
0 Percent (%) of subjects
Interval 0.0 to 12.34
|
0 Percent (%) of subjects
Interval 0.0 to 52.18
|
0 Percent (%) of subjects
Interval 0.0 to 40.96
|
0 Percent (%) of subjects
Interval 0.0 to 33.63
|
0 Percent (%) of subjects
Interval 0.0 to 28.49
|
PRIMARY outcome
Timeframe: 2 years [or until progressive disease or unacceptable toxicity]Population: Efficacy Analysis Set (EAS): Subset of Subjects with a baseline measurement PSA30 and at least 1 measurement post-baseline
The number of subjects who had a confirmed reduction of 30% of prostate-specific antigen (PSA30) from baseline
Outcome measures
| Measure |
Phase 1b HPEC [Heavily Pre-treated Expansion Cohort] CPI-1205 800mg TID +Enza
n=25 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Enza Contro
n=30 Participants
Enzalutamide Control Drug: Enzalutamide 160mg PO QD (28-day cycles) Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Combination With Enza
n=35 Participants
CPI-1205 (at RP2D) Combination with Enzalutamide Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Enzalutamide 160mg PO QD CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Crossover Period
n=12 Participants
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm CPI-1205 +Abi/Pred
n=27 Participants
CPI-1205 (at RP2D) Combination with Abiraterone/Prednisone Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Abiraterone 1000mg PO QD and Prednisone 5mg PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Enza
n=5 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Abi/Pred
n=6 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Enza
n=9 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Abi/Pred
n=10 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
|---|---|---|---|---|---|---|---|---|---|
|
Efficacy: Percentage (%) of Subjects With PSA30
|
7 Participants
|
7 Participants
|
12 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 2 years [or until progressive disease or unacceptable toxicity]Population: Efficacy Analysis Set (EAS): Subset of Subjects with a baseline measurement PSA50 and at least 1 measurement post-baseline
The number of subjects who had a confirmed reduction of 50% of prostate-specific antigen (PSA50) from baseline
Outcome measures
| Measure |
Phase 1b HPEC [Heavily Pre-treated Expansion Cohort] CPI-1205 800mg TID +Enza
n=25 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Enza Contro
n=30 Participants
Enzalutamide Control Drug: Enzalutamide 160mg PO QD (28-day cycles) Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Combination With Enza
n=35 Participants
CPI-1205 (at RP2D) Combination with Enzalutamide Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Enzalutamide 160mg PO QD CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Crossover Period
n=12 Participants
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm CPI-1205 +Abi/Pred
n=27 Participants
CPI-1205 (at RP2D) Combination with Abiraterone/Prednisone Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Abiraterone 1000mg PO QD and Prednisone 5mg PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Enza
n=5 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Abi/Pred
n=6 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Enza
n=9 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Abi/Pred
n=10 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
|---|---|---|---|---|---|---|---|---|---|
|
Efficacy: Percentage (%) of Subjects With PSA50
|
4 Participants
|
5 Participants
|
10 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years [or until progressive disease or unacceptable toxicity]Population: Efficacy Analysis Set (EAS): Subset of Subjects with an unfavorable assessment at baseline and at least one CTC assessment post baseline.
Subjects who had a circulating tumor cell of 30% (CTC 30%) or an objective response rate divided by the number of evaluable subjects
Outcome measures
| Measure |
Phase 1b HPEC [Heavily Pre-treated Expansion Cohort] CPI-1205 800mg TID +Enza
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Enza Contro
Enzalutamide Control Drug: Enzalutamide 160mg PO QD (28-day cycles) Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Combination With Enza
CPI-1205 (at RP2D) Combination with Enzalutamide Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Enzalutamide 160mg PO QD CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Crossover Period
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm CPI-1205 +Abi/Pred
CPI-1205 (at RP2D) Combination with Abiraterone/Prednisone Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Abiraterone 1000mg PO QD and Prednisone 5mg PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Enza
n=35 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Abi/Pred
n=35 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Enza
n=10 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Abi/Pred
n=28 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
|---|---|---|---|---|---|---|---|---|---|
|
Efficacy: Composite Response Rate (%) for Phase 2 Randomized and Phase 2 Single-arm Treatment Groups
|
—
|
—
|
—
|
—
|
—
|
17.1 Percent (%) of subjects
Interval 6.6 to 33.6
|
31.4 Percent (%) of subjects
Interval 16.9 to 49.3
|
0 Percent (%) of subjects
Interval 0.0 to 30.8
|
21.4 Percent (%) of subjects
Interval 8.3 to 41.0
|
SECONDARY outcome
Timeframe: Up to 2 years [or until disease progression or unacceptable toxicity]Population: Efficacy Analysis Set: subjects with a baseline measurement of response and at least 1 timepoint after baseline
Best overall response defined as complete response (CR), partial response (PR); stable disease (SD); progressive disease (PD); and unknown/missing for the Phase 1b dose-escalation group, the Phase 1b HPEC group, the Phase 2 randomized groups, crossover group and the Phase 2 single-arm group. Assessed by Investigator
Outcome measures
| Measure |
Phase 1b HPEC [Heavily Pre-treated Expansion Cohort] CPI-1205 800mg TID +Enza
n=25 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Enza Contro
n=35 Participants
Enzalutamide Control Drug: Enzalutamide 160mg PO QD (28-day cycles) Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Combination With Enza
n=38 Participants
CPI-1205 (at RP2D) Combination with Enzalutamide Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Enzalutamide 160mg PO QD CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Crossover Period
n=12 Participants
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm CPI-1205 +Abi/Pred
n=28 Participants
CPI-1205 (at RP2D) Combination with Abiraterone/Prednisone Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Abiraterone 1000mg PO QD and Prednisone 5mg PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Enza
n=5 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Abi/Pred
n=7 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Enza
n=9 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Abi/Pred
n=11 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
|---|---|---|---|---|---|---|---|---|---|
|
Efficacy: Best Responses by Treatment Group
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy: Best Responses by Treatment Group
PR
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy: Best Responses by Treatment Group
Not evaluable, unknown, or missing
|
3 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Efficacy: Best Responses by Treatment Group
SD
|
10 Participants
|
23 Participants
|
24 Participants
|
5 Participants
|
21 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
|
Efficacy: Best Responses by Treatment Group
PD
|
10 Participants
|
9 Participants
|
7 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years [or until clinical progression, radiographic disease progression, or until unacceptable toxicity]Population: Safety Population: all subjects who receive any amount of treatment (includes phase Ib dose-escalation, phase 1b expansion, phase 2 randomized, phase 2 single-arm)
Treatment-emergent Adverse events (AEs) leading to subjects withdrawing from treatment
Outcome measures
| Measure |
Phase 1b HPEC [Heavily Pre-treated Expansion Cohort] CPI-1205 800mg TID +Enza
n=31 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Enza Contro
n=35 Participants
Enzalutamide Control Drug: Enzalutamide 160mg PO QD (28-day cycles) Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Combination With Enza
n=39 Participants
CPI-1205 (at RP2D) Combination with Enzalutamide Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Enzalutamide 160mg PO QD CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 2 Randomized Crossover Period
n=12 Participants
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm CPI-1205 +Abi/Pred
n=32 Participants
CPI-1205 (at RP2D) Combination with Abiraterone/Prednisone Drug: CPI-1205 (with or without cobicistat) at RP2D + Drug: Abiraterone 1000mg PO QD and Prednisone 5mg PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Enza
n=7 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 400mg BID +Cobi+Abi/Pred
n=8 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 400mg BID OR Drug: CPI-1205 400mg BID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Enza
n=9 Participants
CPI-1205 Combination with Enzalutamide Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Enzalutamide 160mg PO QD (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Enzalutamide: Enzalutamide 160mg PO QD
|
Phase 1b Dose Escalation: CPI-1205 800mg TID +Abi/Pred
n=12 Participants
CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205 PO 800mg TID OR Drug: CPI-1205 800mg TID/Cobicistat 150mg PO BID + Drug: Abiraterone 1000mg PO QD and 5mg Prednisone PO BID (28-day cycles) CPI-1205: CPI-1205 PO TID (either 400mg BID or 800mg TID during Phase 1 dose escalation study and at RP2D for Phase 2) Cobicistat: Cobicistat 150mg PO BID Abiraterone: Abiraterone 1000mg PO QD Prednisone: Prednisone 5mg PO BID
|
|---|---|---|---|---|---|---|---|---|---|
|
Safety: Number of Participants With Treatment-emergent AEs Leading to Treatment Discontinuation
|
4 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Enza
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Abi/Pred
Serious events: 3 serious events
Other events: 8 other events
Deaths: 2 deaths
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Enza
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Abi/Pred
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Phase 1b HPEC: CPI-1205 800 mg TID Heavily Pretreated Expansion Cohort + Enza
Serious events: 11 serious events
Other events: 31 other events
Deaths: 17 deaths
Phase 2 Randomized Control: Enza
Serious events: 8 serious events
Other events: 33 other events
Deaths: 10 deaths
Phase 2 Randomized Experimental: CPI-1205 at RP2D + Enza
Serious events: 5 serious events
Other events: 38 other events
Deaths: 7 deaths
Phase 2 Randomized Crossover Period
Serious events: 0 serious events
Other events: 11 other events
Deaths: 4 deaths
Phase 2 Single Arm: CPI-1205 (at RP2D) + Abi/Pred
Serious events: 1 serious events
Other events: 30 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Enza
n=7 participants at risk
CPI-1205 400 mg BID in combination with Cobicistat 150 mg PO BID and Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Abi/Pred
n=8 participants at risk
CPI-1205 400 mg BID in combination with Cobicistat 150 mg PO BID and Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Enza
n=9 participants at risk
CPI-1205 800 mg TID in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Abi/Pred
n=12 participants at risk
CPI-1205 800 mg TID in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Phase 1b HPEC: CPI-1205 800 mg TID Heavily Pretreated Expansion Cohort + Enza
n=31 participants at risk
CPI-1205 800 mg TID in heavily pretreated expansion cohort in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Control: Enza
n=35 participants at risk
Control group of Phase 2 randomized: Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Experimental: CPI-1205 at RP2D + Enza
n=39 participants at risk
CPI-1205 800 mg TID (RP2D) in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Crossover Period
n=12 participants at risk
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm: CPI-1205 (at RP2D) + Abi/Pred
n=32 participants at risk
CPI-1205 800 mg TID (RP2D) in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
General disorders
Pelvic mass
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Cardiac disorders
Acute coronary syndrome
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Nervous system disorders
Cerebrovascular accident
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Infections and infestations
Cellullitis
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
General disorders
Asthenia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Injury, poisoning and procedural complications
Musculoskeletal procedural complication
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
Other adverse events
| Measure |
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Enza
n=7 participants at risk
CPI-1205 400 mg BID in combination with Cobicistat 150 mg PO BID and Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 400 mg BID + Cobi + Abi/Pred
n=8 participants at risk
CPI-1205 400 mg BID in combination with Cobicistat 150 mg PO BID and Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Enza
n=9 participants at risk
CPI-1205 800 mg TID in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 1b Dose Escalation: CPI-1205 800 mg TID + Abi/Pred
n=12 participants at risk
CPI-1205 800 mg TID in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
Phase 1b HPEC: CPI-1205 800 mg TID Heavily Pretreated Expansion Cohort + Enza
n=31 participants at risk
CPI-1205 800 mg TID in heavily pretreated expansion cohort in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Control: Enza
n=35 participants at risk
Control group of Phase 2 randomized: Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Experimental: CPI-1205 at RP2D + Enza
n=39 participants at risk
CPI-1205 800 mg TID (RP2D) in combination with Enzalutamide 160 mg PO QD (28-day cycles)
|
Phase 2 Randomized Crossover Period
n=12 participants at risk
CPI-1205 800 mg TID (RP2D) combination with Enzalutamide 160 mg PO QD
|
Phase 2 Single Arm: CPI-1205 (at RP2D) + Abi/Pred
n=32 participants at risk
CPI-1205 800 mg TID (RP2D) in combination with Abiraterone 1000 mg PO QD and Prednisone 5 mg PO BID (28-day cycles)
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
42.9%
3/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
37.5%
3/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
77.8%
7/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
33.3%
4/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
38.7%
12/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
51.4%
18/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
59.0%
23/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
50.0%
6/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
18.8%
6/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
General disorders
Axillary Pain
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
General disorders
Peripheral edema
|
28.6%
2/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
22.2%
2/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
5.7%
2/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
2/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
66.7%
6/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
41.7%
5/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
45.2%
14/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
17.1%
6/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
53.8%
21/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
66.7%
8/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
56.2%
18/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
37.5%
3/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
55.6%
5/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
33.3%
4/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
48.4%
15/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
17.1%
6/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
30.8%
12/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
33.3%
4/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
28.1%
9/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
2/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
22.6%
7/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.6%
3/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
10.3%
4/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
9.7%
3/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.6%
3/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
5.1%
2/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
9.4%
3/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.1%
5/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
5.7%
2/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
23.1%
9/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
9.4%
3/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
57.1%
4/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
3/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
19.4%
6/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.7%
9/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
7.7%
3/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
33.3%
4/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.2%
2/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
3/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
44.4%
4/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.1%
5/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
14.3%
5/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.8%
5/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
9.4%
3/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
14.3%
5/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
7.7%
3/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
22.2%
2/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
33.3%
4/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
17.9%
7/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
18.8%
6/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
2/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
37.5%
3/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
22.2%
2/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
3/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
29.0%
9/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
14.3%
5/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
23.1%
9/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
5.7%
2/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
7.7%
3/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
3/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.2%
2/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.6%
1/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.2%
2/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
22.2%
2/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
3/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
2.9%
1/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
15.4%
6/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.2%
2/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
2/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
22.2%
2/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.1%
5/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
5.1%
2/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Investigations
Weight decreased
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.1%
5/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.6%
3/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
10.3%
4/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
9.4%
3/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
10.3%
4/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
2/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.2%
1/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
7.7%
3/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Vascular disorders
Hot flush
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.5%
2/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.4%
4/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
10.3%
4/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.2%
2/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
25.0%
3/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.1%
5/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
14.3%
5/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
10.3%
4/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
33.3%
4/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
18.8%
6/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.5%
1/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.1%
1/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
16.7%
2/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
12.9%
4/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.6%
3/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
8.3%
1/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
6.2%
2/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/8 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/9 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
9.7%
3/31 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
11.4%
4/35 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/39 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
0.00%
0/12 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
3.1%
1/32 • Up to 2 years [or until progressive disease or unacceptable toxicity]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place