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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04821622 | Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC | PHASE3 | ACTIVE NOT_RECRUITING | 599 | — | — | May 12, 2021 | Aug 28, 2027 | Apr 7, 2026 | 311 | United States, Argentina +25 |
| NCT03148795 | A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer | PHASE2 | COMPLETED | 128 | — | — | Jul 4, 2017 | Mar 31, 2023 | Apr 5, 2024 | 120 | United States, Australia +12 |
time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first
Best ORR was defined as the percentage of participants with best overall soft tissue response of complete response (CR) or partial response (PR) as per RECIST1.1 by an independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Talazoparib plus enzalutamide |
| Arm 2 | ACTIVE_COMPARATOR | Placebo plus enzalutamide |
| Talazoparib | EXPERIMENTAL | Talazoparib 1 mg daily |
| Name | Type | Description |
|---|---|---|
| talazoparib plus enzalutamide | DRUG | experimental arm |
| Placebo plus enzalutamide | DRUG | Active comparator arm |
| Talazoparib | DRUG | 1 mg daily |
Inclusion Criteria: 1. Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea). 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the partici...