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

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: Any
Gender: Female

Click here for detailed participation information for this trial.

Sponsor: TESARO, Inc
Dates:
Last Updated:
Study HIC#: 1310012964