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This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - TKI258 - bioavailability | Experimental |
| |
| TKI258 - food effect | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI258 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules) | relative bioavailability (9 days) | |
| Determine the effect of food on the bioavailability of TKI258 | food effect (22 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety and tolerability of TKI258, including acute and chronic toxicities. | Up to 28 days after the last dose of study drug | |
| Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors. | Every 8 weeks until progression of disease |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service | Scottsdale | Arizona | 85258 | United States | ||
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| Label | URL |
|---|---|
| Results for CTKI258A2116 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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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| Duke University Medical Center |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Sarah Cannon Research Institute Sarah Cannon Research Instit | Nashville | Tennessee | 37203 | United States |
| University of Utah / Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |