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| ID | Type | Description | Link |
|---|---|---|---|
| Chinese HA - 2008L09346 | Registry Identifier | Chinese HA |
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This is an open-label, multi-center study to evaluate the safety of RAD001 in Chinese patients with metastatic renal cell cancer who are intolerant of or have progressed despite treatment with vascular endothelial growth factor (VEGF)-targeted therapies. All patients will be treated with RAD001 10 mg daily until tumor progression (determined according to the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria), unacceptable toxicity, death or discontinuation from the study for any other reason. At least 60 patients will be enrolled in the study. Screening and baseline evaluations will be performed within 28 days of the date when the patient signs the informed consent form. Baseline evaluations will be performed within two weeks of the first dose of RAD001. Screening and baseline evaluations will be performed to determine if patient meets all inclusion and exclusion criteria. All eligible patients should be enrolled in the study and will receive the first dose of RAD001 (10 mg daily) on Day 1, Cycle 1. Subsequently, patients will be asked to come to the clinic every month to complete the protocol-specified evaluations. A treatment Cycle consists of 28 days. After discontinuation of treatment with RAD001, patients will have a safety follow-up performed 28 days after the last dose of RAD001. Patients must continue with survival assessments which will be performed every 3 months from the last dose of RAD001 until up to 2 years after the last patient's first visit date.
An interim analysis focusing on safety data and a final analysis of all data are planned. All patients still receiving the study drug at the time of the final analysis will be given the option to continue treatment with RAD001 until the occurrence of unacceptable toxicity or disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus (RAD001) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability profile of RAD001 (10mg daily dose) in Chinese patients who are intolerant of or have progressed on or after VEGF-targeted therapy. | 4 month + 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR), best overall response rate and progression-free survival (PFS) | 12 month | |
| Overall survival (OS) | 12 month | |
| Systemic pre-dose exposure levels of RAD001 in Chinese patients. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol related inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Wuhan | Hubei | 430030 | China | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24886512 | Derived | Li S, Kong Y, Si L, Chi Z, Cui C, Sheng X, Guo J. Phosphorylation of mTOR and S6RP predicts the efficacy of everolimus in patients with metastatic renal cell carcinoma. BMC Cancer. 2014 May 28;14:376. doi: 10.1186/1471-2407-14-376. | |
| 23514360 | Derived | Guo J, Huang Y, Zhang X, Zhou F, Sun Y, Qin S, Ye Z, Wang H, Jappe A, Straub P, Pirotta N, Gogov S. Safety and efficacy of everolimus in Chinese patients with metastatic renal cell carcinoma resistant to vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy: an open-label phase 1b study. BMC Cancer. 2013 Mar 21;13:136. doi: 10.1186/1471-2407-13-136. |
| Label | URL |
|---|---|
| Results for CRAD001L2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| 12 month |
| Nanjing |
| Jiangsu |
| 210002 |
| China |
| Novartis Investigative Site | Beijing | 100028 | China |
| Novartis Investigative Site | Beijing | 100036 | China |
| Novartis Investigative Site | Guangzhou | 510060 | China |
| Novartis Investigative Site | Shanghai | 200127 | China |
| Novartis Investigative Site | Shanghai | 200433 | China |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |