Overview

A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

Status:
Completed

Trial end date:
2019-07-19

Target enrollment:

Participant gender:

Summary

The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.

Phase:

Phase 1

Details

Lead Sponsor:

Janssen Research & Development, LLC

Treatments:

Abiraterone Acetate
Niraparib
Prednisone