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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Available
CT.gov ID
NCT05401214
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05401214
    Other Study ID Numbers:
    • CR109197
    • 67652000MPC4002
    First Posted:
    Jun 2, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Prednisone
    Prednisolone
    Abiraterone Acetate
    Niraparib

    Study Results

    No Results Posted as of Aug 25, 2022