Spots Global Cancer Trial Database for Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
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Trial Identification
Brief Title: Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Official Title: A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Study ID: NCT02074839
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic-AZ, Phoenix, Arizona, United States
City of Hope, Duarte, California, United States
University of California-Los Angeles, Los Angeles, California, United States
University of California-San Francisco, San Francisco, California, United States
University of Colorado Denver, Aurora, Colorado, United States
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern University Medical Hospital, Chicago, Illinois, United States
John Hopkins Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cornell Cancer Center, New York, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Hopital La Timone, Marseille, , France
Hopital Haut-Leveque, Pessac, , France
Central Lyon Sud, Pierre-Bénite, , France
Institute Gustave Roussly (IGR), Villejuif, , France
Contact Details
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