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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male
Study Type
Treatment
NCD ID
NCT03395197
Protocol IDs
C3441021 (primary)
NCI-2018-01651
TALAPRO-2
2017-003295-31
Study Sponsor
Pfizer

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.

Objectives

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.
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