A Maintenance Study 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 was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
ECOG 0-1
Adequate bone marrow, kidney and liver function

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