A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Titre officiel

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

Sommaire:

Le but de cette étude est de comparer l’efficacité du niraparib en association avec l’acétate d’abiratérone et la prednisone (AA-P) à celle de l’AA-P en association avec un placebo.

Description de l'essai

Primary Outcome:

  • Radiographic Progression Free Survival (rPFS)
Secondary Outcome:
  • Overall survival (OS)
  • Time to Chronic Opioid Use
  • Time to Pain Progression
  • Time to Initiation of Cytotoxic Chemotherapy
  • Observed Plasma Concentrations of Niraparib
  • Observed Trough Plasma Concentrations of Abiraterone
  • Number of Participants with Treatment-Emergent Adverse events (TEAEs)
  • Number of Participants with Treatment-Emergent Adverse events by Severity
  • Number of Participants with Laboratory Abnormalities as Measure of Safety
This study will assess efficacy and safety of niraparib in combination with AA-P for the treatment of participants with metastatic prostate cancer. Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone and selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17), which is found in the testes and adrenals, as well as in prostate tissues and tumours. In participants with metastatic prostate cancer, DNA-repair gene defects (DRD) are identified in approximately 15 percent (%) to 20% of tumours. The study will consist of 4 phases: a prescreening phase for biomarker evaluation only, a screening phase, a double-blind treatment phase, and a follow up phase. During the prescreening phase participants will be evaluated for DRD and then will be assigned to one of the 2 cohorts based on their biomarker status. Treatment will be administered daily and is planned to be continuous until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy, pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The total duration of study will be approximately up to 73 months.

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer