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Study was terminated before a MTD was determined for administrative reasons
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| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-406 in combination with daunorubicin and cytarabine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Eligibility Criteria:
Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| J. Mel Sorensen, MD | Ascenta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerity of Chicago | Chicago | Illinois | United States | |||
| University of Michigan Health System |
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| Ann Arbor |
| Michigan |
| United States |
| Washington University at St. Louis Siteman Cancer Center | St Louis | Missouri | 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 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C559144 | N-benzhydryl-5-(2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo(1,2-a)(1,5)diazocine-8-carboxamide |
| D003630 | Daunorubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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