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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03751436 | Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer | PHASE1 | COMPLETED | 10 | — | — | Aug 2, 2019 | Aug 11, 2023 | Oct 16, 2023 | 1 | United States |
The MTD will be determined based on the rate of dose-limiting toxicities (DLTs). Adverse events will be categorized and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Will be selected based on the overall tolerability of the regimen, but will not exceed the MTD.
Prostate Cancer Working Group (PCWG)3 will be used to evaluate PSA response and progression as well as progression on bone scans. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be used to assess response and progression for nodal and visceral metastasis. The Kaplan-Meier product-limit estimator will be used.
| Arm | Type | Description |
|---|---|---|
| Treatment (venetoclax, enzalutamide) | EXPERIMENTAL | Patients receive venetoclax PO QD and enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Enzalutamide | DRUG | Given PO |
| Venetoclax | DRUG | Given PO |
Inclusion Criteria: * Histological or cytological documentation of diagnosis of prostate cancer. * Documented progressive metastatic castrate resistant prostate cancer (mCRPC) based on at least one of the following criteria: * Prostate specific antigen (PSA) progression defined as 25% increase o...