Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Start Date
3/1/2014
Completion Date
12/31/2026
Summary
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AG-120
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Mayo Clinic-AZ
Phoenix, Arizona 85259
United States
City of Hope
Duarte, California 91010
United States
University of California-Los Angeles
Los Angeles, California 90095
United States
University of California-San Francisco
San Francisco, California 94143
United States
University of Colorado Denver
Aurora, Colorado 80045
United States
Mayo Clinic-Jacksonville
Jacksonville, Florida 32224
United States
University of Miami
Miami, Florida 33136
United States
Moffit Cancer Center
Tampa, Florida 33612
United States
Emory University
Atlanta, Georgia 30322
United States
Northwestern University Medical Hospital
Chicago, Illinois 60611
United States
John Hopkins Cancer Center
Baltimore, Maryland 21287
United States
Massachusetts General Hospital
Boston, Massachusetts 02214
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Karmanos Cancer Center
Detroit, Michigan 48201
United States
Washington University
St Louis, Missouri 63110
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Cornell Cancer Center
New York, New York 10065
United States
Duke Cancer Center
Durham, North Carolina 27705
United States
Cleveland Clinic
Cleveland, Ohio 44124
United States
Ohio State University
Columbus, Ohio 43210
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Hopital La Timone
Marseille,
France
Hopital Haut-Leveque
Pessac, 33600
France
Central Lyon Sud
Pierre-Bénite, 69310
France
Institute Gustave Roussly (IGR)
Villejuif, 94800
France