A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell
Both
Carcinoma, Renal Cell
Trial Information
A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma
Inclusion Criteria:
- Histologically proven renal cell carcinoma of clear cell histology with metastases
- Evidence of measurable disease
- Radiographic evidence of disease progression during or within 3 months of completion
of bevacizumab-based treatment
- Prior radical or partial nephrectomy
Exclusion Criteria:
- Prior treatment with any other anti-angiogenic therapy other than bevacizumab
- Prior systemic treatment for RCC > 2 regimens
- History of or known brain metastases
- Serious acute or chronic illness or recent history of significant cardiac abnormality
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome Time Frame:
4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181039
NCT ID:
NCT00089648
Start Date:
December 2004
Completion Date:
March 2008
Related Keywords:
- Carcinoma, Renal Cell
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
