Phase II Study of Niraparib Rechallenge After Surgery in Women With Ovarian Cancer and Limited Metastatic Progression

What this Trial Is About

Researchers are evaluating the effect of niraparib rechallenge treatment after secondary cytoreductive surgery in women with ovarian cancer who experience oligometastatic progression following first maintenance therapy with any PARP inhibitor. This phase II clinical trial focuses on patients with high grade serous or endometrioid ovarian cancer who have 1 to 5 metastatic lesions and no residual tumor after surgery. The main goal is to assess progression-free survival with niraparib treatment in this specific group. Participants will receive oral niraparib tablets at a dose of 300 or 200 mg daily, adjusted based on body weight or platelet count. Treatment will begin within 8 weeks after surgery and continue until disease progression or treatment discontinuation. The study includes no placebo group, and all enrolled patients will receive niraparib continuously in 28-day cycles. During the study, patients will undergo regular assessments including biomarker status evaluations, CA 125 monitoring, and overall survival tracking. Safety will be closely monitored by recording adverse events up to 7 months. Participants must be accessible for follow-up and provide tumor tissue and blood samples at specified intervals. The total participation period includes treatment and follow-up assessments for progression-free survival and overall survival.

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression