Acute Myelogenous Leukemia (AML) Clinical Trial
Official title:
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)
The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.
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
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