Status:
APPROVED_FOR_MARKETING
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Brief 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 pr...
Eligibility Criteria
Inclusion
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
- A confirmed homologous recombination repair (HRR) gene alteration as identified by a genomic assay through use of a validated test
- Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1
- Willing to receive concomitant prednisone/ prednisolone 10 milligrams (mg) (not provided by Janssen) daily while receiving niraparib/abiraterone acetate (Nira/AA) combination treatment
- Willing to continue treatment with gonadotropin-releasing hormone (GnRH) analogue if not surgically castrated
Exclusion
- Prior treatment with a Poly ADP-ribose Polymerase (PARP) inhibitor
- Prior systemic therapy for mCRPC (that is, taxane-based chemotherapy, androgen signaling inhibitors). Ongoing androgen deprivation therapy (ADT), prior systemic treatment (example, apalutamide, enzalutamide, darolutamide, docetaxel) for earlier disease settings (example, hormone sensitive disease, non-metastatic castration-resistant disease); and treatment recently initiated with abiraterone acetate for mCRPC less than or equal to (\<=) 60 days is permitted
- Other treatment options available or participant eligible or able to participate in a clinical trial for first line mCRPC with HRR gene alterations
- Moderate-severe pain
- History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05401214
Last Update
June 13 2025
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