A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

Inclusion Criteria

• Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
• Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
• Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
• Patients Must have completed 3 or 4 previous chemotherapy regimens.
• Patients must have completed their last chemotherapy regimen > 4 weeks prior to treatment initiation.
• Patients must have measurable disease according to RECIST (v.1.1).
• Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
• Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.

Exclusion Criteria

• Patients must not have any known, persistent (> 4 weeks), ≥Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the last cancer therapy.
• Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
• Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
• Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
• Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
• Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).