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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01265199
Other study ID # AT-406-CS-002
Secondary ID
Status Terminated
Phase Phase 1
First received December 20, 2010
Last updated January 21, 2013
Start date February 2011
Est. completion date January 2013

Study information

Verified date January 2013
Source Ascenta Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 74 Years
Eligibility 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.

Study Design

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


Intervention

Drug:
AT-406 in combination with daunorubicin and cytarabine
Oral AT-406 (capsule) given once daily on days 1-5 of induction therapy with daunorubicin 90 mg/m2 I.v. on days 1-3 and cytarabine 100 mg/m2 i.v. by continuous infusion on days 107 of induction therapy.

Locations

Country Name City State
United States University of Michigan Health System Ann Arbor Michigan
United States Univerity of Chicago Chicago Illinois
United States Memorial Sloan Kettering Cancer Center New York New York
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Temple University at Jeanes Hospital Philadelphia Pennsylvania
United States Washington University at St. Louis Siteman Cancer Center St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Ascenta Therapeutics The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 months Yes
Secondary Determine the pharmacokinetic profile of AT-406 and daunorubicin and cytarabine To determine how the drug is absorbed, distributed, metabolized, and eliminated by the body. 15 months No
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