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).