Clinical trial · Expanded Access
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
NCT05401214CI-TRIAL-00091008approved for marketingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niraparib plus Abiraterone Acetate (Nira/AA) combination | Drug | — | UNRESOLVED |
| Prednisone/Prednisolone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.