Niraparib Maintenance Treatment for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+205 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Tesaro, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

Eligibility Criteria

This trial is for adults with advanced Stage III or IV ovarian cancer who've had a good response to initial platinum-based chemotherapy. They must have completed at least 3 cycles of therapy and be within 12 weeks post-chemo. Participants need negative pregnancy tests, agree to genetic testing of their tumor, and can't have more than 9 chemo cycles.

Inclusion Criteria

I have received chemotherapy directly into my abdomen.

My CA-125 levels are normal or have dropped by more than 90% and stayed stable for at least a week.

I agree to have my tumor tested for HRD.

+10 more

Participant Groups

The study is testing Niraparib as a maintenance treatment against a placebo in patients who responded well to first-line chemotherapy. The goal is to see if Niraparib helps keep the cancer from coming back or getting worse over the course of up to seven years.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving NiraparibExperimental Treatment1 Intervention

Group II: Participants receiving PlaceboPlacebo Group1 Intervention