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

NCT04821622 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

talazoparib plus enzalutamide

experimental arm

DRUG

Placebo plus enzalutamide

Active comparator arm

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2026-02-18
Completion
2027-08-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821622 on ClinicalTrials.gov