A Safety and Pharmacokinetics Study of Niraparib Plus Apalutamide in Men With Metastatic Castration-Resistant Prostate Cancer

Official Title

A Safety and Pharmacokinetics Study of Niraparib Plus Apalutamide in Men With Metastatic Castration-Resistant Prostate Cancer

Summary:

The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with apalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.

Trial Description

Primary Outcome:

  • Determine Recommended Phase 2 dose (RP2D) of Niraparib in Combination With 240 milligram (mg) Apalutamide (Part 1)
  • Number of Participants With Incidence and Severity of Adverse Events (Part 2)
Secondary Outcome:
  • Maximum Observed Plasma Concentration (Cmax)
  • Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24])
  • Time to Reach the Maximum Observed Plasma Concentration (Tmax)
  • Minimum Observed Plasma Concentration (Cmin)
  • Prostate Specific Antigen (PSA) Response at 12 Weeks
  • Maximum Prostate Specific Antigen (PSA) Decline

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society