A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell
Both
Carcinoma, Renal Cell
Trial Information
A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma
Inclusion Criteria:
- Histologically proven renal cell carcinoma with metastases
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Exclusion Criteria:
- Prior treatment with more than one systemic therapy for metastatic renal cell
carcinoma
- History of or known brain metastases, spinal cord compression or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease on screening Computed
Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
6 weeks after first dose
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
A3671025
NCT ID:
NCT00372853
Start Date:
November 2006
Completion Date:
May 2010
Related Keywords:
- Carcinoma, Renal Cell
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|---|
| Research Site | Mesa, Arizona |
| Research Site | Belleville, New Jersey |
| Research Site | Akron, Ohio |
| Research Site | Charleston, South Carolina |
| Research Site | Chattanooga, Tennessee |
