Clinical Trials Search
Clinical Trial 18189
Cancer Type: Gynecological Tumor
Study Type: Treatment
Phase of Study: Phase II
- Hye Sook Chon
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Women with Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received at Least Three Previous Chemotherapy Regimens
This study is being done to help find out if niraparib, the study drug, can help delay worsening of ovarian, peritoneal, or fallopian tube cancer among patients who have received at least three previous courses of a chemotherapy drug. This type of treatment, given with the hope of preventing worsening of the cancer after having received at least three previous chemotherapy courses, is known as "fourth line" therapy, referring to the fourth line of treatment.
2.1. Primary Objective: * The primary objective of the study is to evaluate the antitumor activity of niraparib. 2.2. Secondary Objectives: * To evaluate the durability of the antitumor activity of niraparib. * To evaluate antitumor activity of niraparib in HRD-positive patients and in patients with gBRCAmut. * To evaluate the following additional measures of clinical benefit of niraparib: Disease control rate (DCR); Progression-free survival (PFS). * To evaluate the safety and tolerability of niraparib. 2.3. Exploratory Objectives: * To evaluate QTc in a subset of niraparib-treated ovarian cancer patients. * To assess population pharmacokinetics (PK) and estimate PK parameters for niraparib and its major metabolite. * To explore potential biomarkers of PARP inhibitor sensitivity and tolerability.