Study #2014-0800
A Phase 1, 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, with a Substud
MD Anderson Study Status
Enrolling
Treatment Agent
AG-120
Description
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.
Information and next steps
Disease:
Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes
Study phase:
I
Physician name:
Courtney DiNardo
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
Help #EndCancer
Give Now
Donate Blood
Our patients depend on blood and platelet donations.