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Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD)
Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: RAD001 plus sorafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug |
| ||
| RAD001, sorafenib |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of combination RAD001+sorafenib | Until maximum tolerated dose is determined | |
| Time to disease progression assessed when 60 events have been observed | Until number of events are reached |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events | Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity | |
| Tumor response |
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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 |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| UCLA Department of Medicine |
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|
| Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity |
| Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis | Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity |
| Overall tumor response (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Progression Free Survivor, Overall Survivor (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2) | Estimate of 1 year for each patient - Until number of events reached and final analysis |
| Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose | Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity |
| Los Angeles |
| California |
| 90005 |
| United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Novartis Investigative Site | Amsterdam | Netherlands |
| Novartis Investigative Site | Seoul | South Korea |
| Novartis Investigative Site | Barcelona | Spain |
| Novartis Invstigative Site | Madrid | Spain |
| Novartis Investigative Site | Tainan | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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