Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk, Acute Myelogenous Leukemia (AML)
This is an open label, multi-center, dose escalation study to determine the MTD of oral
AT-406 combined with daunorubicin and cytarabine in patients with poor-risk AML. Treatment
with AT-406 will be administered to up to 60 patients at approximately 7 investigational
sites in the US. Patients will be enrolled in open label sequential cohorts of up to 12
patients to determine the MTD of AT-406 in combination with daunorubicin and cytarabine.
Dose finding will occur during the induction cycle of the regimen. AT-406 will not be
administered in consolidation cycles. Patients who require re-induction during initial
treatment will be removed from the study and replaced (if needed) in order to assess at
least 3 evaluable patients at each dose level.
Clinical and laboratory parameters will be assessed to evaluate the toxicity of AT-406. In
addition, pharmacokinetic (PK) and pharmacodynamic (PDy) blood samples will be analyzed for
plasma concentrations and PDy effect of AT-406, respectively.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of oral AT-406 in combination with daunorubicin and cytarabine.
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of AT-101.
J. Mel Sorensen, MD
Ascenta Therapeutics, Inc.
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Hospital of the University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|University of Michigan Health System||Ann Arbor, Michigan|
|Univerity of Chicago||Chicago, Illinois|
|Washington University at St. Louis Siteman Cancer Center||St. Louis, Missouri|
|Temple University at Jeanes Hospital||Philadelphia, Pennsylvania|