Clinical Trial DRUG AG221-C-001
- 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
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG AG221-C-001
- 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.
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
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last updated: 05-Oct-15 04:33 PM
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