Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
A Phase 2 Study of AZD2171 in Patients With Advanced Renal Cell Carcinoma
This phase II trial is studying how well AZD2171 works in treating patients with refractory metastatic kidney cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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