Phase II Study of Alternative Niraparib Dosing to Reduce Dose Interruptions in First-Line Maintenance Treatment for Advanced High-Grade Ovarian Cancer

What this Trial Is About

Researchers are evaluating an alternative dosing approach of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. This single-arm phase II study focuses on patients who have completed at least four cycles of front-line platinum-based chemotherapy and have achieved a complete or partial response. The study aims to assess the frequency of blood-related and other side effects, dose interruptions, reductions, discontinuations, and progression-free survival at 24 months. Participants will receive oral niraparib starting at 100 mg daily for the first two 28-day cycles. If tolerated, the dose will increase to 200 mg daily for the third and fourth cycles. Patients will continue on their individualized dose until they experience side effects requiring dose adjustment or disease progression occurs. The study plans to enroll 40 patients at a single site. During the study, participants will provide blood samples before starting treatment, weekly for the first month, and as outlined in the protocol. Researchers will monitor adverse events, dose changes, and progression-free survival over two years. The study includes safety assessments and ongoing evaluations to understand how this dosing affects treatment continuation and patient outcomes.

Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer