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

Phase 1 Completed 34 enrolled Janssen Research & Development, LLC

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2016-10-03
Primary completion: 2019-07-18
Completion: 2019-07-19

Publications

Saad F, Chi KN, Shore ND, Graff JN, Posadas EM, Lattouf JB, Espina BM, Zhu E, Yu A, Hazra A, De Meulder M, Mamidi RNVS, Bradic B, Francis P, Hayreh V, Rezazadeh Kalebasty A. Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE). Cancer Chemother Pharmacol. 2021 Jul;88(1):25-37. doi: 10.1007/s00280-021-04249-7. Epub 2021 Mar 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	1000 mg	—
Subject	Apalutamide	Small molecule	240 mg	Oral
Subject	Niraparib	Small molecule	200 mg	—
Subject	Niraparib	Small molecule	300 mg	—
Background	Prednisone	Other / unclassified	10 mg	—

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

Summary

Timeline

Publications

Drugs

Indications