NCT03395197

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,054 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• mCRPC

Interventions

Type	Name	Description
DRUG	Talazoparib with enzalutamide	Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
DRUG	Placebo with enzalutamide	Placebo plus enzalutamide 160 mg/day

Timeline

• Start date: 2017-12-18
• Primary completion: 2022-10-03
• Completion: 2027-06-30
• First posted: 2018-01-10
• Last updated: 2026-04-07
• Results posted: 2024-01-17

Locations

368 sites across 26 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Japan, New Zealand, Norway, Peru, Poland, Portugal, South Africa, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study