A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
18 Years and older, Male
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.
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.