Last updated on May 2018

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


Brief description of study

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

Detailed Study Description

This is a multicenter, *open-label, Phase 2 study to look at how safe and effective niraparib (**a PARP inhibitor) is in women with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients must have already received at least 3 chemotherapy regimens (including, but not limited to gemcitabine, doxorubicin, topotecan, carboplatin, oxaliplatin, cisplatin, bevacizumab, or PARP inhibitors as single agents or in combination). The study will look at whether treatment with niraparib will benefit these patients in terms of the ***overall response rate (ORR).

* Open label means that all patients will receive the study drug. A Phase 2 trial tests a drug's effectiveness and further tests its' safety.

** A PARP inhibitor is a substance that blocks an enzyme in cells called PARP. PARP helps repair DNA when it becomes damaged. DNA damage may be caused by many things, including exposure to ultraviolet light, radiation, certain anticancer drugs, or other substances in the environment. In cancer treatment, blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. - NCI Dictionary of Cancer Terms

***Overall Response Rate is the percentage of patients whose cancer shrinks or disappears after treatment - NCI Dictionary of Cancer Terms

Clinical Study Identifier: TX6714

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