Last updated on June 2015

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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Dr. Benedict Benigno

Northside Hospital
Atlanta, GA USA
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Dr. Erika Hamilton

SCRI Tennessee Oncology
Nashville, TN USA
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Dr. Prasanthi Ganesa

SCRI Center for Cancer and Blood Disorders
Fort Worth, TX USA
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Dr. Dan Spitz

SCRI Florida Cancer Specialists
West Palm Beach, FL USA
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Dr. Kathleen Moore

University of Oklahoma
Oklahoma City, OK USA
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Dr. Patricia Braly

Women’s Cancer Center
Covington, LA USA
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Dr. John Chan

Sutter West Bay
San Francisco, CA USA
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Dr. Daniela Matei

IU Melvine and Bren Cancer Center
Indianapolis, IN USA
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Dr. Gini Fleming

University of Chicago
Chicago, IL USA
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Dr. Mario Javier Pineda

Northwestern University
Evanston, IL USA
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Dr. Veena John

North Shore Long Island Jewish
New Hyde Park, NY USA
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Dr. Paul DiSilvestro

Women and Infants Hospital
Providence, RI USA
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Dr. Christine Lee

Texas Oncology
The Woodlands, TX USA
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Dr. Noelle Cloven

Texas Oncology
Fort Worth, TX USA
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Dr. Donald Richards

Texas Oncology
Tyler, TX USA
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Dr. Michael Teneriello

Texas Oncology
Austin, TX USA
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Dr. Michael Callahan

St. Vincent Hospital
Indianapolis, IN USA
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Dr. Corrine Zarwan

Lahey Clinic
Burlington, MA USA
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Dr. Michael Bookman

Arizona Oncology Associates
Tucson, AZ USA
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Dr. Snehal Bhoola

Arizona Oncology Associates
Phoenix, AZ USA
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