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This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKI258 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI258 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites | Day 15 | |
| Cohort 2: Safety and Tolerability of TKI258 | Time to patient withdrawal due to disease progression or tolerability issues |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Safety and tolerability of TKI258 | Time to patient withdrawal due to disease progression or tolerability issues | |
| Cohort 1: Preliminary anti-tumor activity of TKI258 | Time to tumor progression |
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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 Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23010851 | Derived | Dubbelman AC, Upthagrove A, Beijnen JH, Marchetti S, Tan E, Krone K, Anand S, Schellens JH. Disposition and metabolism of 14C-dovitinib (TKI258), an inhibitor of FGFR and VEGFR, after oral administration in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Nov;70(5):653-63. doi: 10.1007/s00280-012-1947-2. Epub 2012 Aug 22. |
| Label | URL |
|---|---|
| Results for CTKI258A2106 can be found on the Novartis Clinical Trial Results Website | View source |
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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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| Preliminary Anti-tumor activity of TKI258 | Time to tumor progression |