Talazoparib + Enzalutamide vs. Enzalutamide monotherapy in mCRPC (TALAPRO-2)
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC (TALAPRO-2)
ClinicalTrials.gov ID: NCT03395197
Sponsor: Pfizer
Information provided by: Pfizer (Responsible Party)
Last Update Posted: 2024-09-05
Brief Summary:
This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
Detailed Description:
Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and PK at select sites. Part 2 is a randomized, double-blind, placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide in patients with mCRPC.
Official Title:
A phase 3, randomized, double-blind, placebo-controlled study of talazoparib with enzalutamide in metastatic castration-resistant prostate cancer
Intervention / Treatment:
- Drug: Talazoparib with enzalutamide
- Drug: Placebo with enzalutamide
| Category | Value |
|---|---|
| Study Start (Actual) |
2017-12-18
|
| Primary Completion (Actual) |
2022-10-03
|
| Study Completion (Estimated) |
2025-12-31
|
| Enrollment (Actual) | 1054 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
C3441021
2017-003295-31 (EudraCT Number) TALAPRO-2 (Other Identifier) (OTHER: Alias Study Number) |