MLN4924 for the Treatment of Acute Myelogenous Leukemia, Myelodysplastic Syndrome, and Acute Lymphoblastic Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

August 31, 2013

Study Completion Date

October 31, 2013

Conditions
Acute Myelogenous LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic Syndrome
Interventions
DRUG

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)"

DRUG

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)

Trial Locations (6)

21287

Johns Hopkins Kimmel Cancer Center, Baltimore

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

60657

Robert H. Lurie Comprehensive Cancer Center Northwestern University, Chicago

78229

Institute for Drug Development, San Antonio

94305

Stanford University Medical Center, Stanford

02115

Dana Farber Cancer Institute, Boston

All Listed Sponsors
lead

Millennium Pharmaceuticals, Inc.

INDUSTRY