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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017969-30 | EudraCT Number |
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This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEQ506 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEQ506 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506 | 21 day cycles |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety and tolerability of LEQ506 treatment | 21 day cycles | |
| To characterize the pharmacokinetics of LEQ506 | 21 day cycles | |
| To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles UCLA LeConte Location | Los Angeles | California | 90095 | United States | ||
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| Label | URL |
|---|---|
| Results for CLEQ506X2101 on the Novartis Clinical Trials website | View source |
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| 21 day cycles |
| Tumor response | every 6 weeks |
| Memorial Sloan Kettering Cancer Center |
| New York |
| New York |
| 10021 |
| United States |
| Novartis Investigative Site | Utrecht | 3584CX | Netherlands |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Novartis Investigative Site | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008527 | Medulloblastoma |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| 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 |
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| ID | Term |
|---|---|
| C586455 | NVP-LEQ506 |
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