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The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDE225 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDE225 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| determine maximum tolerated dose of single agent LDE225 | 28 day cycles |
| Measure | Description | Time Frame |
|---|---|---|
| characterize safety and tolerability | 28 day cycles | |
| characterize pharmacokinetics (PK) of single and repeated doses of LDE225 | 28 day cycles | |
| assess preliminary anti-tumor activity |
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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 | Hong Kong | Hong Kong | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27467121 | Derived | Minami H, Ando Y, Ma BB, Hsiang Lee J, Momota H, Fujiwara Y, Li L, Fukino K, Ito K, Tajima T, Mori A, Lin CC. Phase I, multicenter, open-label, dose-escalation study of sonidegib in Asian patients with advanced solid tumors. Cancer Sci. 2016 Oct;107(10):1477-1483. doi: 10.1111/cas.13022. Epub 2016 Sep 24. |
| Label | URL |
|---|---|
| Results for CLDE225X1101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D008527 | Medulloblastoma |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C561435 | sonidegib |
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| 28 day cycles |
| Nagoya |
| Aichi-ken |
| 466-8560 |
| Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0017 | Japan |
| Novartis Investigative Site | Taipei | 10048 | Taiwan |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002277 | Carcinoma |
| D018295 | Neoplasms, Basal Cell |