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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

Cancer Type
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase I
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Protocol IDs
AG120-C-001 (primary)
Study Sponsor
Agios Pharmaceuticals


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.

Anticipated time on study treatment is until disease progression or unacceptable toxicity


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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