Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

NCT ID: NCT05401214

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

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.

Intervention Type: DRUG

Prednisone/Prednisolone

Prednisone/Prednisolone 10 mg will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Other Identifiers

67652000MPC4002

Identifier Type: OTHER

Identifier Source: secondary_id

CR109197

Identifier Type: -

Identifier Source: org_study_id