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INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INC280 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INC280 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part | Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events, changes in laboratory values | Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment. | 4 months |
| Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2 |
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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 | Kashiwa | Chiba | 277-8577 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CINC280X1101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| C000613976 | capmatinib |
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Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months. |
| 1 month |
| Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM | Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM | 4 months |
| Fukuoka |
| 811-1395 |
| Japan |