A Phase III Study of Niraparib as Maintenance Therapy after Initial Chemotherapy for Women with Ovarian Cancer

Full Title

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 (PR-30-5017-C: GOG-3012)

Purpose

Niraparib is a drug used to treat ovarian cancer that came back and then shrank following platinum-based chemotherapy. In this study, researchers want to assess its effectiveness for prolonging cancer-free survival among woman with inoperable or metastatic ovarian cancer that responded to their first treatment with platinum-based therapy.

Niraparib works by inhibiting PARP, a protein that helps cancer cells repair DNA that has been damaged by cancer treatments, especially in cancers with mutated BRCA. When cancer cells repair damaged DNA, they can continue growing and multiplying, so depriving them of this power with a PARP inhibitor may be an effective approach to treatment.

Patients in this study will be randomly assigned to receive niraparib or a placebo. Niraparib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage III or IV ovarian cancer that shrank following initial chemotherapy that included platinum-containing drugs.
  • Patients must join the study within 12 weeks of the first day of their last cycle of chemotherapy.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.

Protocol

17-208

Phase

III

Investigator

Co-Investigators