Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Active:	No
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT04821622
Trial Phases:	Phase III	Protocol IDs:
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Pfizer Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT04821622

Summary

The purpose of the study is to evaluate the safety and efficacy of talazoparib in
combination with enzalutamide compared with placebo in combination with enzalutamide in
participants with DDR-deficient mCSPC.

Objectives

The study will have 5 periods: prescreening, screening, double-blind treatment, safety
follow-up, and long-term follow-up.

Approximately 550 men with mCSPC will be randomized. Eligible participants will be
randomly assigned to either of 2 treatment groups as follows:

- Talazoparib in combination with enzalutamide.

- Placebo capsules identical in appearance to talazoparib capsules in combination with
enzalutamide.

Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day)
will be open label. The dose of talazoparib/placebo to be given in combination with
enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR
30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the
talazoparib/placebo dose will be 0.35 mg once daily.

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