A Phase 2 Study of AZD2171 in Patients With Advanced Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with refractory metastatic renal cell
carcinoma treated with AZD2171.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of AZD2171 in these patients. II. Determine the
feasibility of performing standardized delayed contrast-enhancement-MRI correlative studies
across different institutions and platforms with data-sharing capability in patients with
metastatic renal cell cancer.
III. Generate preliminary data regarding potential utility of pharmacogenomic and
plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future
investigations of AZD2171 and renal cell carcinoma.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 6 weeks.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective radiologic response as measured by RECIST criteria
Up to 6 weeks
No
Walter Stadler
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-02686
NCT00303862
March 2006
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |