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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-003017-16 | EudraCT Number |
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This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD 5mg/day + erlotinib | Experimental |
| |
| erlotinib 150mg/day | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug |
| ||
| erlotinib |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose. | first 28 days of combined treatment | |
| Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1 | at baseline and after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression | at baseline, monthly until month 4 then q2months until progression | |
| Phase 2: Safety and steady state drug levels evaluated monthly |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharmaceuticals | Novartis Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Atlanta | Georgia | 30322 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CRAD001C2111 can be found on the Novartis Clinical Trial Results Website | View source |
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| Drug |
|
| Monthly |
| Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue | Dec 2009 |
| Chicago |
| Illinois |
| 60637-1470 |
| United States |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | United States |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Houston | Texas | 77030-4009 | United States |
| Novartis Investigative Site | Madison | Wisconsin | 53792 | United States |
| Novartis Investigative Site | Richmond | British Columbia | V7C 5L9 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Novartis Investigative Site | Herlev | DK-2730 | Denmark |
| Novartis Investigative Site | Saint-Herblain Cédex | 44805 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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