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The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKI258 | Experimental | dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI258 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) of TKI258 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Antineoplastic activity based on the RECIST criteria | 22 months |
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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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Takatsuki | Osaka | 569-8686 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CTKI258A1101 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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| Hidaka |
| Saitama |
| 350-1241 |
| Japan |