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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: Completed Phase 2 study of Bladder Cancer and Metastasis, sponsored by Bristol-Myers Squibb.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.
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 |
What the finished NCT00389155 record still lists
NCT00389155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00389155's enrollment target sits among peer trials
34 131st of 175 higher than 44 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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