Niraparib tosylate monohydrate + abiraterone acetate - Film coated tablet- 79.90 mg (eq. 50mg base)+ 500mg
Sponsors
Janssen - Cilag International, Karolinska Institutet
Conditions
Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)Metastatic Prostate CancerProstate Cancer
Phase 3
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Active, not recruitingCTIS2023-506365-64-00
Start: 2020-10-16Target: 211Updated: 2026-01-13
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer
Active, not recruitingCTIS2023-503254-12-00
Start: 2019-03-06Target: 235Updated: 2025-12-09
ProBio: An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer
RecruitingCTIS2023-506857-40-00
Start: 2019-01-08Target: 1750Updated: 2025-12-15