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Clinical trial

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

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Last updated:4th Jul 2017
Identifier: NCT03148795

The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)
Actual Study Start Date: July 4, 2017
Estimated Primary Completion Date: April 3, 2020
Estimated Study Completion Date: March 3, 2022

Arm:
- Experimental:
Talazoparib

Category Value
Date last updated at source 2019-04-16
Study type(s) Interventional
Expected enrolment 100
Study start date 2017-07-04
Estimated primary completion date 2020-04-03

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