133
Participants
Start Date
September 11, 2007
Primary Completion Date
July 31, 2013
Study Completion Date
April 5, 2016
Subcutaneous (SC) Azacitidine
75 mg/day for first 7 days of 28 day cycle for 1 cycle only.
Oral Azacitidine
Cycle 2 and beyond starting dose of 120 mg/day for first 7 days of 28 day cycle. Dose will escalate in increments of 60 mg. Following evaluation dose escalation will occur in 120 mg increments until maximum tolerated dose (MTD) is reached.
Oral Azacitidine
Starting dose for 14 day-QD treatment schedule will be 300 mg/day. Starting dose for 14 day-BID, 21 day-QD, 21 day-BID treatment schedules will be 100 mg, 200mg, 300mg. Dose will escalate in increments of 100 mg until MTD is reached.
New York Oncology Hematology P.C., Albany
Virginia Oncology Associates, Norfolk
Institute for Translational Oncology Research IRB, Greenville
Sarah Cannon Research Institute, Nashville
Gabrail Cancer Center, Canton
Central Indiana Cancer Centers, Indianapolis
Mayo Clinic, Rochester
University of Chicago Medical Center, Chicago
Kansas City VA Medical Center University of Kansas Medical Center, Kansas City
Kansas University Medical Center, Westwood
MD Anderson Cancer Center, Houston
HOAST, San Antonio
Texas Oncology Cancer Care, Austin
Comprehensive Cancer Centers of Nevada, Las Vegas
Yakima Valley Memorial Hospital/ North Star Lodge, Yakima
University of Florida, Gainesville
Johns Hopkins Hospital, Baltimore
Fred Hutchinson Cancer Research Center, Seattle
Lead Sponsor
Celgene
INDUSTRY