Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enzalutamide · 1 trial · 9 indications
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...
Enzalutamide is being studied for use in patients with castration levels of testosterone, specifically in metastatic castration-resistant prostate cancer. It is an investigational small molecule in oncology that has been evaluated in a completed Phase 1 clinical trial for this condition.
Enzalutamide is an androgen receptor inhibitor, meaning it works by blocking the androgen receptor pathway. This mechanism is relevant in prostate cancer, where androgen receptor signaling drives tumor growth even when testosterone levels are castrate.
Enzalutamide is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research on this drug for prostate cancer indications.
Enzalutamide is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently listed. The drug remains investigational and has not been approved for any indication.
Enzalutamide was studied in a completed Phase 1 trial with the identifier NCT03751436. The trial evaluated enzalutamide in combination with venetoclax in patients with metastatic castration-resistant prostate cancer. It enrolled 10 participants in the United States and was not randomized or blinded.
Enzalutamide is the generic name for the drug marketed as Xtandi. In the clinical trial data, the drug is referred to as enzalutamide, and it is being studied for prostate cancer. The brand name Xtandi is commonly used to refer to this same compound.