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Clinical Trials

Topic   Cancer - Gynecologic Cancer
Title   Tesaro: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Summary   The aim of this study is to evaluate the efficacy of Niraparib versus placebo as maintenance treatment, as measured by progression-free survival, in patients with Stage III or IV ovarian cancer (including fallopian and peritoneal cancers). It is also the goal of the study to evaluate the safety and tolerability of Niraparib versus placebo.
Description   Patients will be randomly assigned to one of two possible treatment arms. Both the study drug niraparib and placebo will be administered orally in 28-day cycles in a double blind fashion for up to 3 years.
IRB Number   20160205
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following: Must be at least 18 years of age and have diagnosed high-grade serous endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is considered Stage III or IV. Patients must agree to undergo tumor HRD testing. Those who have mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer will not be eligible to this study.
Status   Open
Principal Name   Eva Chalas, MD
Contact Name   Christina Egan, RN
Email   CEgan@NYUWinthrop.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1216
Alternate Phone   516-663-8391