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Clinical Trial DRUG AG120-C-001

Title
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation
Principal Investigator
Jessica Altman
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG AG120-C-001
Purpose
The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. We want to find out what effects, good or bad, it has on patients and their disease.
Overview
The use of AG-120 (hereafter, the study drug) in this research study is experimental, which means that it is not approved by the U.S. Food and Drug Administration (FDA) or other regulatory authorities around the world for use alone or in combination with any drug. Isocitrate dehydrogenase 1 (IDH1) is a type of protein involved in metabolism or the process of providing the body’s cells with energy. In certain types of diseases such as AML and MDS, an abnormal form of the IDH1 protein is present in the diseased cells. When IDH1 is present in this form, it produces an excess amount of 2-hydroxyglutarate (2-HG), which is a substance that is normally present in cells in low levels. When 2-HG is present in excessive amounts, it may prevent cells from maturing into normal functioning cells and may cause them to become diseased. AG-120 may stop the abnormal IDH1 protein and may reduce 2-HG levels in diseased cells to normal levels.
Eligibility
Some of the eligibility criteria include:
  • Participants must have advanced acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
  • Participants must be 18 or older.
  • Lab tests must show that the participants have IDH1 gene-mutated disease.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants in this study will take the study drug by mouth in the form of a tablet(s) every day as indicated by the study doctor. The study drug may be continued until the participant's disease gets worse or unacceptable side effects develop.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 22-Dec-14 08:57 PM

 

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