Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005806-38 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | 5mg or 10mg po daily |
| |
| RG1507 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of RAD001, in combination with R1507 (Part 1 | First 3 week cycle of treatment | |
| Progression-free survival (Part 2) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall objective response rate; duration of response; overall survival | Event driven; monitored throughout study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York | New York | 10017 | United States | |||
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| C558734 | RG-1507 monoclonal antibody |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
16mg/kg iv every 3 weeks |
|
| San Antonio |
| Texas |
| 98229 |
| United States |
| Milan | Lombardy | 20133 | Italy |