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Protocol # 19-241

Status

Active, not recruiting

Description

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Condition

  • Castration-Resistant Prostatic Cancer

Interventions

  • Niraparib
  • Abiraterone Acetate
  • Prednisone
  • Placebo
  • New Formulation of Niraparib and Abiraterone Acetate (AA)

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Cohort 1 and 3: Radiographic Progression Free Survival (rPFS)

Secondary Outcome:

  • Cohort 1: Overall survival (OS)
  • Cohort 1: Time to Symptomatic Progression
  • Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
  • Cohort 1: Observed Plasma Concentrations of Niraparib
  • Cohort 1: Observed Trough Plasma Concentrations of Abiraterone
  • Cohort 1: Number of Participants with Treatment-Emergent Adverse events (TEAEs)
  • Cohort 1: Number of Participants with Treatment-Emergent Adverse events by Severity
  • Cohort 1: Number of Participants with Laboratory Abnormalities as Measure of Safety

Enrollment

765

Study Start Date

January 25, 2019

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Janssen Research & Development, LLC

Source

Janssen Research & Development, LLC

Official title

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

Clinicaltrials.gov Identifier

NCT03748641

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.