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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT05401214
• Other study ID #: CR109197
• Secondary ID: 67652000MPC4002
• Status: Approved for marketing

Study information

• Verified date: September 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• 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
• 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)

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

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,