Niraparib Maintenance Treatment for Ovarian Cancer

Palo Alto (17 mi)

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.

My Stage IV cancer can be operated on.

My doctor says my cancer responded well after 3 or more treatment cycles.

My cancer is at an advanced stage and cannot be removed by surgery.

I have stage III cancer and still have visible cancer after initial surgery.

I've had at least 2 rounds of platinum-based therapy after surgery to remove my cancer.

I have advanced ovarian, fallopian tube, or peritoneal cancer.

I have had between 6 and 9 rounds of platinum-based chemotherapy.

I have stage III or IV cancer and received chemotherapy and surgery to reduce the tumor.

Treatment Details

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