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This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily dosing RAD001 | Experimental |
| |
| Weekly dosing RAD001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1 | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen | within 6 cycles (Day 126) | |
| PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| University of Colorado Health Sciences Center |
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| Label | URL |
|---|---|
| Results for CRAD001C2116 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
|
| During the first 6 cycles |
| Overall tumor response | Every 6-8 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Dana Faber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Cancer Therapy and Research Center at UTHSCSA | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Paris | France |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |