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

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status

Conditions

Metastatic Castration-resistant Prostate Cancer

Treatments

Drug: Niraparib plus Abiraterone Acetate (Nira/AA) combination
Drug: Prednisone/Prednisolone

Study type

Expanded Access

Funder types

Industry

Identifiers

NCT05401214
67652000MPC4002 (Other Identifier)
CR109197

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

5

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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