Condition: Relapsed or Refractory Acute Myeloid Leukemia (AML) · Untreated AML · Other IDH1-mutated Positive Hematologic Malignancies · Sponsor: Institut de Recherches Internationales Servier
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.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier Clinical Studies Department · +33 1 55 72 43 66 · scientificinformation@servier.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Active Not Recruiting |
| Mayo Clinic-AZ | Phoenix, Arizona, United States | Terminated |
| City of Hope | Duarte, California, United States | Active Not Recruiting |
| University of California-Los Angeles | Los Angeles, California, United States | Terminated |
| University of California-San Francisco | San Francisco, California, United States | Terminated |
| University of Colorado Denver | Aurora, Colorado, United States | Terminated |
| Mayo Clinic-Jacksonville | Jacksonville, Florida, United States | Terminated |
| University of Miami | Miami, Florida, United States | Terminated |
| Moffit Cancer Center | Tampa, Florida, United States | Active Not Recruiting |
| Emory University | Atlanta, Georgia, United States | Active Not Recruiting |
| Northwestern University Medical Hospital | Chicago, Illinois, United States | Terminated |
| John Hopkins Cancer Center | Baltimore, Maryland, United States | Active Not Recruiting |
+ 18 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02074839