Acute Myeloid Leukemia Clinical Trial
A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
Summary
This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.
Full Description
This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of APTO-253 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory acute myelogenous leukemia (AML) or high-risk MDS patients. This is to be followed by a cohort expansion phase at the MTD or recommended dose.
Eligibility Criteria
Inclusion Criteria:
Patients ≥18 years old
Life expectancy of at least 2 months
Off previous cancer therapy for at least 14 days, or 5 half-lives for noncytotoxic agents prior to first study treatment administration
Patients must have a calculated creatinine clearance >60 mL/min
Acceptable hematologic, renal and liver functions and coagulation status parameters
Exclusion Criteria:
Patients with GVHD requiring systemic immunosuppressive therapy
Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
Clinically significant intravascular coagulation
Treatment with other investigational drugs within 14 days prior to first study treatment administration
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There are 13 Locations for this study
Tucson Arizona, 85724, United States
La Jolla California, 92093, United States
Orange California, 92868, United States
Atlanta Georgia, 30322, United States
New Orleans Louisiana, 70121, United States
Ann Arbor Michigan, 48109, United States
Billings Montana, 59102, United States
Rochester New York, 14643, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97239, United States
Greenville South Carolina, 29605, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
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