Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

  • STATUS
    Not Recruiting
  • End date
    Nov 25, 2024
  • participants needed
    1150
  • sponsor
    Pfizer
Updated on 19 August 2022
Investigator
Pfizer CT.gov Call Center
Primary Contact
Keio University Hospital (5.2 mi away) Contact
+492 other location

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.

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.

Details
Condition mCRPC
Treatment Talazoparib with NHT, Placebo with NHT, Talazoparib with enzalutamide, Placebo with enzalutamide
Clinical Study IdentifierNCT03395197
SponsorPfizer
Last Modified on19 August 2022

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