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Study was stopped due to time dependent drug accumulation
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The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKI258 - dose escalation | Experimental | Dose-Escalation |
|
| TKI258 - dose expansion | Experimental | Dose-Expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI258 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | 28 days - dose-escalation; 4 months - dose-expansion | |
| Dose limiting toxicity | 28 days - dose-escalation; 4 months - dose-expansion | |
| Safety profile | 28 days - dose-escalation; 4 months - dose-expansion |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of plasma pharmacokinetics and pharmacodynamics | 28 days - dose-escalation; 4 months - dose-expansion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas, M.D. Anderson Cancer Center | Houston | Texas | 77020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23400739 | Derived | Wang X, Kay A, Anak O, Angevin E, Escudier B, Zhou W, Feng Y, Dugan M, Schran H. Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013 Jan;53(1):14-20. doi: 10.1177/0091270011433330. Epub 2013 Jan 24. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C500007 | 4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one |
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| D006425 |
| Hemic and Lymphatic Diseases |