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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

Status
Active
Cancer Type
Leukemia
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCT ID
NCT02074839
Protocol IDs
AG120-C-001 (primary)
NCI-2014-00720
Study Sponsor
Agios Pharmaceuticals

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.

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

occurs.

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