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NCT00389155 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Bladder Cancer and Metastasis, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target
20
Study locations

NCT00389155 is a Phase 2 study of Bladder Cancer and Metastasis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 34 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00389155, a Phase 2 study of Bladder Cancer and Metastasis, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target
20
Study locations

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.

Interventions

  • OTHER Placebo
  • DRUG Gemcitabine
  • DRUG Vinflunine

Study Locations (20)

California

  • Tower Hematology Oncology Medical Group - Beverly Hills
  • Local Institution - Concord
  • Glendale Memorial Hospital And Health Center - Glendale
  • Moores Ucsd Cancer Center - La Jolla
  • North Valley Hematology/Oncology Medical Group - Mission Hills
  • Local Institution - Orange
  • Stanford University - Stanford

Florida

  • University Of Florida College Of Medicine At Jacksonville - Jacksonville
  • Local Institution - Jacksonville
  • Lakeland Regional Cancer Center - Lakeland
  • University Of Miami - Miami
  • Advanced Medical Specialties - Miami

Georgia

  • Medical College Of Georgia - Augusta
  • Central Georgia Cancer Care, Pc - Macon

Illinois

  • University Of Chicago - Chicago
  • Springfield Clinic, Llp - Springfield

Alabama

  • University Of Alabama At Birmingham - Birmingham

Arizona

  • Acrc/Arizona Clinical Research Center, Inc. - Tucson

Delaware

  • Local Institution - Newark

Indiana

  • Michiana Hematology Oncology, P.C. - South Bend

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2007-01
Est. Completion 2008-01
Phase Phase 2

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT00389155

The ClinicalTrials.gov registry entry for NCT00389155 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00389155 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00389155 about?

NCT00389155 is a clinical study titled "First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy". 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 t...

What is the current status of trial NCT00389155?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2007-01. Estimated completion is 2008-01.

What conditions does trial NCT00389155 study?

This clinical trial studies the following conditions: Bladder Cancer, Metastasis, Transitional Cell Carcinoma.

What interventions are being tested in trial NCT00389155?

The interventions under investigation include: Placebo (OTHER), Gemcitabine (DRUG), Vinflunine (DRUG).

Who is sponsoring clinical trial NCT00389155?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00389155 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.