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

Part of paid clinical trials in West Hollywood, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02924766
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Participants will start with niraparib 200 mg once daily.
  • Apalutamide — DRUG
    Participants will receive apalutamide 240 mg (4\*60 mg) once daily orally.
  • Abiraterone Acetate — DRUG
    Participants will receive 1000 mg (4\*250mg) once daily.
  • Prednisone — DRUG
    Participants will receive 10 mg (1\*5 mg twice daily).

Study Details

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.

Key Dates

Start date
Oct 3, 2016
Status verified
Jul 2020
Primary completion
Jul 18, 2019
Completion
Jul 19, 2019

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib + Apalutamide/[Abiraterone Acetate + Prednisone]
    Participants will receive initial starting dose of Niraparib 200 milligram (mg) once daily in combination either with Apalutamide 240 mg (4\*60 mg) once daily or Abiraterone Acetate 1000 mg (4\*250 mg) plus 10 mg Prednisone (5 mg twice daily) for 28 days of cycle 1. Once a safe dose of niraparib is selected with each Andrgen Receptor (AR)-targeted therapy \[Apalutamide or Abiraterone Acetate plus Prednisone\], then an expansion phase (Part 2) will open to further explore safety and assess antitumor activity.

Primary Outcome Measure

Determine Recommended Phase 2 dose (RP2D) of Niraparib in Combination With 240 milligram (mg) Apalutamide or 1,000 mg Abiraterone Acetate Plus 10 mg Prednisone (5 mg Twice Daily) in Part 1 [ Time Frame: Up to 56 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
-West HollywoodCalifornia--
-LouisvilleKentucky--
-PortlandOregon--
-Myrtle BeachSouth Carolina--

Find similar trials in West Hollywood, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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