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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)


Phase 1
18 Years
74 Years
Not Enrolling
Both
Acute Myelogenous Leukemia (AML)

Thank you

Trial Information

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.

Inclusion Criteria


Eligibility Criteria:

Inclusion:

- Male or females patients ages 18 to 74

- Morphological diagnosis of untreated or relapsed non-M3 AML according to WHO
diagnostic criteria who exhibit at least one poor-risk feature and are not be known
to exhibit any favorable cytogenetic features or variants.

- Patients with relapsed AML and patients with prior autologous or allogeneic
hematopoietic stem cell transplantations are eligible if relapse occurred following a
remission of ≥ 6 months.

- Patients must have an ECOG score of ≤ 2,

- Adequate cardiac, liver and renal function.

Exclusion:

- Must not have any evidence of CNS leukemia.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of oral AT-406 in combination with daunorubicin and cytarabine.

Outcome Description:

Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of AT-101.

Outcome Time Frame:

15 months

Safety Issue:

Yes

Principal Investigator

J. Mel Sorensen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ascenta Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AT-406-CS-002

NCT ID:

NCT01265199

Start Date:

February 2011

Completion Date:

January 2013

Related Keywords:

  • Acute Myelogenous Leukemia (AML)
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of Michigan Health SystemAnn Arbor, Michigan  
Univerity of ChicagoChicago, Illinois  
Washington University at St. Louis Siteman Cancer CenterSt. Louis, Missouri  
Temple University at Jeanes HospitalPhiladelphia, Pennsylvania