Last updated on November 2017

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Brief description of study

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Detailed Study Description

You are being asked to take part in this study because you have high grade serous ovarian primary peritoneal or fallopian tube cancer. Standard chemotherapy for your type of cancer usually consists of two drugs called carboplatin and paclitaxel. This treatment has been found to be effective, but many subjects will eventually see their cancer reappear, and need additional treatment. In this study, an investigational drug called veliparib is being studied when added to carboplatin and paclitaxel and continued after chemotherapy to see if it improves the outcome for women with ovarian cancer. An investigational drug is one that has not been approved by the regulatory authorities in your country or other countries.

The purpose of this study is to compare the combination of carboplatin, paclitaxel and veliparib to carboplatin, paclitaxel, and placebo followed by continued therapy with either veliparib or placebo to determine if it slows the progression of your cancer. During this study we will be treating subjects with previously untreated stages II and IV high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. A BRCA gene test will be required for your participation to further assess treatment response. You will need to have this sample collected, even if you have already been tested for it previously.

Clinical Study Identifier: TX8023

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Pamela Treas

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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