NCT00315237

Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract

Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 364 (estimated)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.

Conditions

• Transitional Cell Carcinoma of the Urothelial Tract
• Bladder Cancer
• Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	vinflunine and best supportive care	solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-04-18
• Last updated: 2010-01-07

Locations

10 sites across 1 country: Canada