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

NCT00389155 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-12-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Greece
  • Indonesia
  • Italy
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00389155 on ClinicalTrials.gov