Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT05401214
- Status
- Approved For Marketing
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Niraparib plus Abiraterone Acetate (Nira/AA) combination — DRUGNira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets.
- Prednisone/Prednisolone — DRUGPrednisone/Prednisolone 10 mg will be administered orally.
Study Details
The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.
Key Dates
- Status verified
- Jun 2025
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