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

NCT05401214 | Unknown

• 2 other identifiers: CR10919767652000MPC4002
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 DRUG

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

Prednisone/Prednisolone DRUG

Prednisone/Prednisolone 10 mg will be administered orally.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Interventions

niraparib; Abiraterone Acetate; Prednisone; Prednisolone

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Pregnadienetriols

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Last Updated: June 13, 2025

Record last verified: 2025-06