Bladder Cancer Clinical Trial
Official title:
A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
The study objectives include the determination of the antitumor effect of SU011248 in
patients with urothelial transitional cell carcinoma and to also determine the toxicities and
tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have
failed or are intolerant to cisplatin-based chemotherapy.
The primary endpoint of the study is to compare progression free survival at 4 months in
patients who received SU011248 plus BSC versus patients who received placebo plus BSC
The secondary endpoint is to compare the objective response rate and duration of response in
patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to
describe the QOL and safety profile of SU011248 when compared to placebo and to describe the
overall survival in patients who received SU011248 plus BSC versus patients who received
placebo plus BSC
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