31
Participants
Start Date
August 12, 2008
Primary Completion Date
April 6, 2016
Study Completion Date
April 7, 2016
azacitidine
"Arm 1:~Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.~Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.~Arm 2:~All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle."
Main Cancer Centers of Florida, P.A., Ocoee
Indiana University School of Medicine, Indianapolis
Washington University School of Medicine, St Louis
University of Kansas Medical Center, Kansas City
University of Texas- MD Anderson, Houston
Hematology and Oncology Assoc. of South Texas, San Antonio
Northwest Cancer Specialists, P.C., Albuquerque
California Cancer Care Inc, Greenbrae
Willamette Valley Cancer Institute, Springfield
Yakima Valley Memorial Hospital/ North Star Lodge, Yakima
Fred Hutchinson Cancer Research Center, Seattle
Lead Sponsor
Celgene
INDUSTRY