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

NCT00315237 Phase 3 COMPLETED

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.

Details

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 3
Status	COMPLETED
Enrolment	364
Start date	2005-07
Completion	2008-01

Conditions

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

Interventions

• vinflunine and best supportive care

Primary outcomes

• duration of Overall Survival after Randomization — 30-March-07

Countries

Canada