drugset / Trial / NCT05401214
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
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.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 500 mg | Oral |
| Subject | Niraparib | Small molecule | 100 mg | Oral |
| Background | Prednisolone | Other / unclassified | 10 mg | Oral |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |