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

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

October 3, 2016

Primary Completion Date

July 18, 2019

Study Completion Date

July 19, 2019

Conditions
Prostatic Neoplasms
Interventions
DRUG

Niraparib

Participants will start with niraparib 200 mg once daily.

DRUG

Apalutamide

Participants will receive apalutamide 240 mg (4\*60 mg) once daily orally.

DRUG

Abiraterone Acetate

Participants will receive 1000 mg (4\*250mg) once daily.

DRUG

Prednisone

Participants will receive 10 mg (1\*5 mg twice daily).

Trial Locations (6)

Unknown

West Hollywood

Louisville

Portland

Myrtle Beach

Vancouver

Montreal

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02924766 - A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) | Biotech Hunter | Biotech Hunter