Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT03025867
Eligibility Criteria:
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
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03025867
Study Brief:
Protocol Section:
NCT03025867