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This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-675,206 | Drug | CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug | 6 weeks after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported | 18 months | |
| To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination | up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | 85258 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| SU011248 | Drug | SU011248 administered at a dose of 37.5mg/day every day. |
|
| CP-675,206 | Drug | CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested. |
|
| SU011248 | Drug | SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks. |
|
| To monitor for an antibody response to CP-675,206 | up to 18 months |
| To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled | 6-18 months after last subject enrolled |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Greenville | South Carolina | 29605 | United States |
| Research Site | Memphis | Tennessee | 38120 | United States |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |