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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT05401214
Other study ID # CR109197
Secondary ID 67652000MPC4002
Status Approved for marketing
Phase
First received
Last updated

Study information

Verified date September 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
Prednisone/Prednisolone
Prednisone/Prednisolone 10 mg will be administered orally.

Locations

Country Name City State
Austria DUMMY Dummy
Brazil DUMMY Dummy
Estonia DUMMY Dummy
Israel DUMMY Dummy
Mexico DUMMY Dummy

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Austria,  Brazil,  Estonia,  Israel,  Mexico, 

See also
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