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The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis | every 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria | 6 weeks | |
| Date and reason of death, or discontinuation from the study. | 12 weeks |
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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 |
| Novartis Pharmaceuticals | Novartis Investigative Site | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Beijing | Beijing Municipality | 100730 | China | ||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Guangzhou |
| Guangdong |
| 510030 |
| China |
| Novartis Investigative Site | Changchun | Jilin | China |
| Novartis Investigative Site | Shenyang | Liaoning | China |