A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

Inclusion Criteria:

- 18 years of age or older, female, any race

- Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal
cancer

- High grade (or grade 3) serous histology or known to have gBRCAmut

- Has received at least 2 previous courses of platinum-containing therapy, and has
disease that is considered platinum sensitive (more than 6 month period between
penultimate platinum regimen and progression of disease) and has response to last
platinum regimen

- ECOG 0-2

- Adequate bone marrow, kidney and liver functi

Exclusion Criteria:

- Known hypersensitivity to the components of niraparib

- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous
cell carcinoma of the skin that has been definitely treated)

- Symptomatic uncontrolled brain metastasis

- Is pregnant or breast feeding

- Immunocompromised patients

- Known active hepatic disease

- Prior treatment with a known PARP inhibitor