Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
NCT00389155 · View on ClinicalTrials.gov ↗
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00389155
The ClinicalTrials.gov registry entry for NCT00389155 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00389155 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00389155?
The interventions under investigation include: Placebo (OTHER), Gemcitabine (DRUG), Vinflunine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00389155?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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