72
Participants
Start Date
June 30, 2009
Primary Completion Date
August 31, 2013
Study Completion Date
October 31, 2013
MLN4924
"MLN4924 intravenous (IV) on a 21-day cycle on one of the following schedules:~* Days 1, 3, and 5, followed by a rest period of 16 days (Schedule A)~* Days 1, 4, 8, and 11, followed by a rest period of 10 days (Schedule B)~* Continuous weekly dosing on Days 1, 8, and 15 (Schedule C)~* Days 1, 4, 11, 15 for Cycle 1 only; Days 1, 4, 8, 11 for all subsequent cycles (Schedule D)~* Dosing on Days 1, 3, and 5 in patients with high-grade MDS or AML (Schedule E)"
Azacitidine
Azacitidine will be administered (IV or subcutaneous (SC)) on Days 8 to 12 and Days 15 and 16 in Cycle 1, and on Days 1 to 5 and Days 8 to 9 (Schedule D)
Johns Hopkins Kimmel Cancer Center, Baltimore
University of Michigan Comprehensive Cancer Center, Ann Arbor
Robert H. Lurie Comprehensive Cancer Center Northwestern University, Chicago
Institute for Drug Development, San Antonio
Stanford University Medical Center, Stanford
Dana Farber Cancer Institute, Boston
Lead Sponsor
Millennium Pharmaceuticals, Inc.
INDUSTRY