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In this study, BYL719 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 investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BYL719 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BYL719 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by type, frequency and severity of adverse events | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. | 4 Months |
| Efficacy assessed by RECIST |
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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 | 460-0001 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CBYL719X1101 can be found on the Novartis Clinical Trials Results Website | View source |
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| ID | Term |
|---|---|
| C585539 | Alpelisib |
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Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. RECIST - Response Evaluation Criteria In Solid Tumors |
| 4 months |
| To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2) | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. | 4 months |
| Levels of biomarkers in tumor and skin | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. | 4 months |
| Nagoya |
| Aichi-ken |
| 466 8560 |
| Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 104-0045 | Japan |
| Novartis Investigative Site | Koto-ku | Tokyo | 135 8550 | Japan |