Trials / Approved For Marketing
Approved For MarketingNCT05401214
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib plus Abiraterone Acetate (Nira/AA) combination | Nira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets. |
| DRUG | Prednisone/Prednisolone | Prednisone/Prednisolone 10 mg will be administered orally. |
Timeline
- First posted
- 2022-06-02
- Last updated
- 2025-06-13
Source: ClinicalTrials.gov record NCT05401214. Inclusion in this directory is not an endorsement.