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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 study has been terminated.
(Study was terminated before a MTD was determined for administrative reasons)
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Ascenta Therapeutics
ClinicalTrials.gov Identifier:
NCT01265199
First received: December 20, 2010
Last updated: January 21, 2013
Last verified: January 2013
History of Changes

December 20, 2010
January 21, 2013
February 2011
January 2013   (final data collection date for primary 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. [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of AT-101.
Same as current
Complete list of historical versions of study NCT01265199 on ClinicalTrials.gov Archive Site
Determine the pharmacokinetic profile of AT-406 and daunorubicin and cytarabine [ Time Frame: 15 months ] [ Designated as safety issue: No ]
To determine how the drug is absorbed, distributed, metabolized, and eliminated by the body.
Same as current
Not Provided
Not Provided
 
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 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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myelogenous Leukemia (AML)
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01265199
AT-406-CS-002
No
Ascenta Therapeutics
Ascenta Therapeutics
The Leukemia and Lymphoma Society
Study Director: J. Mel Sorensen, MD Ascenta Therapeutics, Inc.
Ascenta Therapeutics
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP