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Trial of Maintenance SU011248 Versus Placebo Post Chemotherapy Patients With Advanced Urothelial Carcinoma

Urothelial Carcinoma Clinical Trial

Official title:
Randomized Blinded Phase II Trial of Maintenance SU011248 Versus Placebo Post Chemotherapy Patients With Advanced Urothelial Carcinoma

Clinical Trial Summary

This is a randomized Blinded Phase II trial of Maintenance SU011248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma.

Clinical Trial Description

The primary objective of this study is to compare the progression rate associated with SU011248 versus Placebo in patients with advanced urothelial carcinoma who have achieved at least stable disease following combination chemotherapy. Secondary objectives of the trial: We will explore the safety of SU011248, assess the objective response rate associated with SU011248 therapy in patients with stable disease after chemotherapy, and assess the median survival in patients with advanced urothelial carcinoma treated with SU011248 or placebo following chemotherapy. Correlative objectives of trial: To correlate changes in VEGF and sVEGFR-2 levels with clinical response in patients with advanced urothelial carcinoma. Tertiary objective of trial: Determine response and progression rates to SU011248 in patients crossed over to treatment after placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01225848
Study type Interventional
Source Abramson Cancer Center of the University of Pennsylvania
Contact
Status Completed
Phase Phase 2
Start date February 2010
Completion date October 2013
View Details
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