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The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | 10 mg/day (2 tablets of 5 mg each) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by RECIST criteria | 18 months | |
| To assess progression free survival (PFS) and overall survival (OS) | 18 months | |
| To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0 |
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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 | Aichi | Japan | ||||
| Novartis investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20231677 | Result | Doi T, Muro K, Boku N, Yamada Y, Nishina T, Takiuchi H, Komatsu Y, Hamamoto Y, Ohno N, Fujita Y, Robson M, Ohtsu A. Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancer. J Clin Oncol. 2010 Apr 10;28(11):1904-10. doi: 10.1200/JCO.2009.26.2923. Epub 2010 Mar 15. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| 18 months |
| Chiba |
| Japan |
| Novartis investigative Site | Ehime | Japan |
| Novartis Investigative Site | Hokkaido | Japan |
| Novartis investigative Site | Osaka | Japan |
| Novartis investigative Site | Shizuoka | Japan |
| Novartis Investigative Site | Tochigi | Japan |
| Novartis investigative Site | Tokyo | Japan |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |