A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Part 1 (Safety Lead-In): Assess the safety and tolerability of SGI-110 and carboplatin by the incidence of dose limiting toxicities and other adverse events to determine the maximum tolerated dose for Part 2
Number of patients with adverse events Incidence of dose limiting toxicities
9 months
Yes
United States: Food and Drug Administration
SGI-110-02
NCT01696032
September 2012
July 2014
Name | Location |
---|---|
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Chicago | Chicago, Illinois 60637 |
Johns Hopkins Kimmel Cancer Center | Baltimore, Maryland 21231-1000 |
Georgia Health Sciences University | Augusta, Georgia 30912 |
Island Gynecologic Oncology | Brightwaters, New York 11718 |
Women's Cancer Care | Covington, Louisiana 70433 |
Norris Comprehensive Cancer Center- University of Southern California | Los Angeles, California 90033 |
Cedars Sinai Medical Center - Samuel Oschin Comprehensive Cancer Unit | Los Angeles, California 90048 |
Melvin and Bren Simon Cancer Center- Indiana University | Indianapolis, Indiana 46202 |
Duke Cancer Institute- Duke University Medical Center | Durham, North Carolina 27710 |