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Brief Title: A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
Official Title: A Phase 2 Dose-Escalation Study of AEB1102 (Co-ArgI-PEG) in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Refractory to Hypomethylating Agents
Study ID: NCT02732184
Brief Summary: This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Comprehensive Cancer Center at University of Michigan, Ann Arbor, Michigan, United States
Washington University Medical School, Saint Louis, Missouri, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
The Cleveland Clinic, Cleveland, Ohio, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Baylor Scott & White, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Alberta, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Name: Jim Joffrion
Affiliation: Aeglea BioTherapeutics, Inc.
Role: STUDY_DIRECTOR