Clinical trial · Expanded Access
Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer
- 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)
This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer. This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA). To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.
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 |
|---|---|---|---|
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niraparib | Drug | Niraparib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 2. Completion of at least 2 previous courses of platinum-containing chemotherapy. 3. Had a CR or PR with duration of response \>/=6 months following penultimate chemotherapy 4. Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy \[minimum of 4 cycles\] 5. Patients previously treated with PARP inhibitors are eligible 6. Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1 7. Adequate organ function \[Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL\] 8. Able to take oral medications 9. Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib 10. Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy Exclusion Criteria: 1. Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy 2. Known hypersensitivity to the components of niraparib 3. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment 4. Patient has uncontrolled hypertension
References
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