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Brief Title: Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA
Official Title: A Phase II Simon Two-Stage Study of the Addition of Pracinostat to a Hypomethylating Agent (HMA) in Patients With Myelodysplastic Syndrome (MDS) Who Have Failed to Respond or Maintain a Response to the HMA Alone
Study ID: NCT01993641
Brief Summary: The purpose of this open label study is to determine whether combining pracinostat (study drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent hypomethylating agent (HMA), and to provide additional safety and efficacy data.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Southern Cancer Center, Mobile, Alabama, United States
City of Hope, Duarte, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Sutter Medical Group, Sacramento, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Yale School of Medicine, New Haven, Connecticut, United States
Florida Cancer Specialist South, Fort Myers, Florida, United States
Florida Cancer Specialist North, St Petersburg, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
University of Kentucky, Lexington, Kentucky, United States
John Theurer Cancer Center, Hackensak, New Jersey, United States
Oncology Hematology Care, Cincinati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States
Tennessee Oncology-Chattanooga, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas Southwestern, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Name: Guillermo Garcia-Manero, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR