Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Recruiting now · Phase 1
Conditions studied: Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT02074839
- Run by
- Institut de Recherches Internationales Servier
- People needed
- 291
- Starts
- 2014-03-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Hopital Haut-Leveque — Pessac, France (enrolling)
- Central Lyon Sud — Pierre-Bénite, France (enrolling)
- Institute Gustave Roussly (IGR) — Villejuif, France (enrolling)
- Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
- University of Miami — Miami, Florida, United States
- Moffit Cancer Center — Tampa, 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
- University of Alabama at Birmingham — Birmingham, Alabama, 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
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Hopital La Timone — Marseille, France
- Washington University — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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