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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002759-34 |
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This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| everolimus + Pemetrexed - daily | Experimental | Daily treatment |
|
| everolimus + Pemetrexed - weekly | Experimental | Weekly treatment |
|
| 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. All proposed dose levels in this study can be given as a combination of these dose strengths. Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed. |
| Measure | Description | Time Frame |
|---|---|---|
| Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate. | Over 18 weeks of combination treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST) | Over 18 weeks of combination treatment |
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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 |
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Camperdown | New South Wales | 2050 | Australia | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CRAD001C2112 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D006147 |
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|
|
| Pemetrexed | Drug | Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline |
|
| Melbourne |
| Victoria |
| 3002 |
| Australia |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |