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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
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05401214
Enrollment
Unknown
Registered
2022-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-resistant Prostate Cancer

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 prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.

Interventions

DRUGPrednisone/Prednisolone

Prednisone/Prednisolone 10 mg will be administered orally.

DRUGNiraparib plus Abiraterone Acetate (Nira/AA) combination

Nira 100 milligrams (mg)/AA 500 mg combination will be administered orally as immediate-release film coated tablets.

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

Inclusion criteria

* 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 criteria

* 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026