This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Stage III patients must have visual evidence of disease. Additionally, patients must have a normal or>90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Patient must have histologically confirmed, advanced (FIGO Stage III or IV)high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed first line platinum based chemotherapy (neoadjuvant or adjuvant)
Patient must have clinical complete response or partial response following completion of chemotherapy course.
All Stage IV patients are eligible, irrespective of residual disease, after primary or interval debulking. Stage III patients are required to have visible residual disease after primary surgery. Patients with inoperable Stage III and IV disease are eligible
Patient must agree to undergo tumor HRD testing
Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy
Main Exclusion Criteria:
Patient has mucinous or clear cell subtypes of epithelial ovarian cancer,carcinosarcoma or undifferentiated ovarian cancer
Patient has undergone more than 2 debulking surgeries
Patient has received bevacizumab with first-line platinum based therapy
Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving study treatment and for 3 months after the last dose of study treatment
Patient has had prior treatment with a known PARP inhibitor
Patient has been diagnosed and/or treated for invasive cancer (other than ovarian cancer)