An expanded access record providing Niraparib plus Abiraterone Acetate (Nira/AA) combination and Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer, sponsored by Janssen Research & Development, LLC. Approved for marketing. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Janssen Research & Development, LLC · Expanded access
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
Browse Prostatic Neoplasms studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Exclusion Criteria:
Nira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets.
Prednisone/Prednisolone 10 mg will be administered orally.
No study locations are listed for this record.
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Janssen Research & Development, LLC