A Phase III Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer

Conditions

What is the purpose of this trial?

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle.


Participation Guidelines

Age:
Gender:
Female

Click here for detailed information about who can participate in this trial.


Sponsor:
TESARO, Inc
Dates:
03/25/2014
Last Updated:
Study HIC#:
1310012964