Clinical Trial 18189

Cancer Type: Gynecological Tumor
Interventions:Niraparib

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Hye Sook Chon

Overview

Study Title

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

Summary

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.

Objective

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.

Inclusion Criteria

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  • Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed.
  • Histologically diagnosed recurrent high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • Must have completed at least 3 previous chemotherapy regimens.
  • Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Adequate bone marrow, kidney and liver function.

  • Exclusion Criteria

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  • Known hypersensitivity to the components of niraparib.
  • Symptomatic uncontrolled brain metastasis.
  • Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated).
  • Is pregnant or breast feeding.
  • Immunocompromised patients.
  • Known active hepatic disease.