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Clinical Trial DRUG AG221-C-001

Title
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects with Advanced Hematologic Malignancies with an IDH2 Mutation
Principal Investigator
Jessica Altman
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG AG221-C-001
Purpose
The purpose of this study is to find the highest dose of AG-221 that can be given safely. Another purpose of this study is to find out what effects, good and/or bad, study drug AG-221 has on advanced hematological malignancies.
Overview
Certain hematological malignancies (disease affecting the blood or bone marrow) such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) may an abnormal type of protein in their cells. AG-221 is an investigational drug not approved by the U.S. Food and Drug Administration (FDA) that targets this abnormal protein. In cases where disease is advanced and does not respond to standard (FDA approved) treatment or has returned options for treatment are limited. The medical and research communities are always looking for promising new treatments which are experimental.
Eligibility
Some of the eligibility criteria include:
  • Participants must be 18 years or older.
  • Participants must have relapsed (cancer returned) or refractory (cancer did not respond to treatment) AML.
  • Participants with other advanced hematologic malignancies may be eligible. Contact the study doctor for more details.
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 will take AG-221 twice a day orally (by mouth) for 28 days (1 cycle). Participants will continue to receive AG-221 in cycles until disease worsens or the study doctor feels it is in their best interest to stop.
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: 21-Oct-14 10:04 AM

 

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