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In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BKM120 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKM120 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| establish Maximum tolerate dose (MTD) | every day up to first 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by type, frequency and severity of adverse events | Every week | |
| Efficacy assessed by RECIST | Every 2 months | |
| Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples |
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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 | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CBKM120X1101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| C571178 | NVP-BKM120 |
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| Every 2 weeks up to first 4 weeks, then every odd cycle |
| Measurement of biomarkers for PI3K pathway in blood and tissue | First 4 weeks |
| Kashiwa |
| Chiba |
| 277-8577 |
| Japan |