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)
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 |
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.
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Ascenta Therapeutics | The Leukemia and Lymphoma Society |
United States,
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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