clinical trial · NCT03395197
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPCTalazoparib with enzalutamidePlacebo with enzalutamide
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.
started
Dec 18, 2017
primary completion
Oct 3, 2022
completion
Jun 30, 2027
last updated
Sep 29, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol