Status:
TERMINATED
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)
Lead Sponsor:
Ascenta Therapeutics
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Conditions:
Acute Myelogenous Leukemia (AML)
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief 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 d...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01265199
Start Date
February 1 2011
End Date
January 1 2013
Last Update
January 23 2013
Active Locations (6)
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1
Univerity of Chicago
Chicago, Illinois, United States
2
University of Michigan Health System
Ann Arbor, Michigan, United States
3
Washington University at St. Louis Siteman Cancer Center
St Louis, Missouri, United States
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States