NCT00389155

First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

Conditions

• Bladder Cancer
• Transitional Cell Carcinoma
• Metastasis

Interventions

Type	Name	Description
DRUG	Vinflunine	solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
DRUG	Gemcitabine	solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
OTHER	Placebo

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-10-18
• Last updated: 2015-12-07

Locations

112 sites across 16 countries: United States, Australia, Belgium, Canada, Denmark, France, Greece, Indonesia, Italy, Philippines, Poland, Russia, South Korea, Spain, Thailand, United Kingdom