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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002760-26 | EudraCT Number |
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This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab
This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step 1 Arm 1 | Experimental | 5mg/day RAD001 + Carboplatin + Paclitaxel |
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| Step 1, Arm 2 | Experimental | 30mg/week RAD001 + Carboplatin + Paclitaxel |
|
| Step 2, Arm 1 | Experimental | 5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab |
|
| Step 2, Arm 2 | Experimental | 30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | 5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate | Ever 3 months or once a critical DLT occurs |
| Measure | Description | Time Frame |
|---|---|---|
| Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1) | End of step 1 | |
| Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2) | End of Step 2 | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114 | Washington D.C. | District of Columbia | 20007-2197 | United States |
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|
| PK parameters derived from PK profiles of treatment drugs alone and in combination |
| End of Step 1 and Step 2 |
| Best overall response - measured by CT/MRI scan every 6-8 week | Every 6-8 week |
| LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center | New Orleans | Louisiana | 70115 | United States |
| U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office | Dallas | Texas | 75390-9151 | United States |
| MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc. | Houston | Texas | 77030-4009 | United States |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | Heidelberg | Victoria | 3084 | Australia |
| Novartis Investigative Site | Essen | 45122 | Germany |
| Novartis Investigative Site | Heidelberg | 69126 | Germany |
| 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 |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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