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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005603-26 | EudraCT Number |
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This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.
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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 |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center SC | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) |
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| Label | URL |
|---|---|
| Results for CLDE225X2101 on Novartis Clinical Trials 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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| every other 28-day cycle |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Novartis Investigative Site | Leicester | LE1 5WW | United Kingdom |
| 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 |