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Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation


Active: Yes
Cancer Type: Hematopoietic Malignancies
Leukemia
NCT ID: NCT02074839
Trial Phases: Phase I Protocol IDs: AG120-C-001 (primary)
NCI-2014-00720
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Institut de Recherches Internationales Servier
NCI Full Details: http://clinicaltrials.gov/show/NCT02074839

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.
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