Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03263650 | Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC | PHASE2 | ACTIVE NOT_RECRUITING | 96 | — | — | Oct 3, 2017 | Jun 30, 2026 | Feb 17, 2026 | 1 | United States |
Progression Free Survival (PFS) calculated as the time from randomization until any one of the following events occurs, whichever comes first: * Documented disease progression * Start of a new therapy in the absence of progression * Death in the absence of progression
| Arm | Type | Description |
|---|---|---|
| Cabazitaxel + Carboplatin | EXPERIMENTAL | Cabazitaxel, Cabazitaxel and Carboplatin intravenously on day 1 of cycles 1-6. Prednisone by mouth twice daily on days 1-21 of cycles 1-6. |
| Olaparib Maintenance | EXPERIMENTAL | Participants randomized to receive Olaparib by mouth twice daily on Day 1 of cycle 7. |
| Observation Only | NO_INTERVENTION | Participants randomized to observation only beginning cycle 7. |
| Name | Type | Description |
|---|---|---|
| Cabazitaxel | DRUG | 25mg/m2 administered intravenously over 60 minutes on day 1 of cycles 1-6; given before carboplatin. |
| Carboplatin | DRUG | AUC 4 administered intravenously over 60 minutes on day 1 of cycles 1-6 |
| Prednisone 5Mg | DRUG | 5 mg administered by mouth twice daily on days 1-21 of cycles 1-6. |
| Olaparib | DRUG | Administered by mouth twice daily at a dose of 300 mg by mouth twice daily, dispensed on Day 1 of cycle 7 to participants randomized to receive olaparib maintenance and every 21 days thereafter until the participant completes the study, withdraws from the study or the closure of the study. |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Provision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be exclu...