An open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with acute myelogenous leukemia (AML), high-grade myelodysplastic syndrome (MDS). The patient population will consist of adults previously diagnosed with AML including high-grade MDS for which standard curative, life-prolonging treatment does not exist or is no longer effective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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 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)
Stanford University Medical Center
Stanford, California, United States
Robert H. Lurie Comprehensive Cancer Center Northwestern University
Chicago, Illinois, United States
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements
Time frame: 12 months
Pharmacokinetic parameters
Time frame: 12 months
Pharmacodynamic effects
Time frame: 12 months
Assess disease response
Time frame: 12 months
Heart corrected QT intervals
Time frame: During screening and during Cycle 1, Days 1 and 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Institute for Drug Development
San Antonio, Texas, United States