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Brief Title: Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome
Official Title: A Phase 2 Randomized Double-Blind Placebo-Controlled Study of Pracinostat in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk-2 or High-Risk Myelodysplastic Syndrome (MDS)
Study ID: NCT01873703
Brief Summary: The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treatment for Myelodysplastic Syndrome (MDS).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Southern Cancer Center, Mobile, Alabama, United States
Scripps Cancer Center, La Jolla, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Florida Cancer Specialists South, Fort Myers, Florida, United States
Woodlands Medical Specialists, Pensacola, Florida, United States
Florida Cancer Specialists North, Saint Petersburg, Florida, United States
Florida Cancer Specialist and Research Institute, Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Indiana University Simon Cancer Ctr, Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer at Johns Hopkins, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Henry Ford Hospital, Detroit, Michigan, United States
Michigan State University, Lansing, Michigan, United States
Nebraska Methodist, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Weill Cornell Medical Center, New York, New York, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Tennessee Oncology - Chattanooga, Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center, Tennessee Oncology, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Name: Guillermo Garcia-Manero, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR