A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

What is the purpose of this trial?

This study is a double-blind, randomized (2:1 niraparib:placebo), placebo-controlled study in patients with ovarian cancer who have HRD-positive tumors, as identified with a centralized HRD test, and are at high risk for progressive disease (PD), as identified by the stage of cancer and previous response to surgery. Patients must have received at least 4 cycles of a front-line platinum-based regimen with a physician-assessed response of CR or PR (no measurable lesion >2 cm). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess whether maintenance treatment with niraparib will extend PFS in this population. Stratification factors will include best response during the front-line platinum regimen (CRand PR).

Participation Guidelines

Gender: Female only


Dates: 02/02/2017 - 05/31/2020

Last Updated: 02/22/2018

Study HIC#: 1605017713