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This study assesses the tolerability, safety, efficacy and pharmacokinetics of everolimus in Japanese patients. Everolimus is administered orally everyday to adult patients with relapsed or refractory non-Hodgkin's lymphoma who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolmus | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma | whole study period | |
| To assess the pharmacokinetics in Japanese patients | 1st sycle |
| Measure | Description | Time Frame |
|---|---|---|
| To seek preliminary evidence of efficacy in this population | Every 2 cycles |
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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 | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CRAD001C1104 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Nagoya |
| Aichi-ken |
| 466-8650 |
| Japan |
| Novartis Investigative Site | Kashiwa | Chiba | Japan |
| Novartis Investigative Site | Isehara | Kanagawa | 259-1193 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-8574 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | Japan |
| Novartis Investigative Site | Fukuoka | 811-1395 | Japan |
| Novartis Investigative Site | Kyoto | 602-8566 | Japan |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |