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NCT00625664 · ClinicalTrials.gov registry record · Phase 3
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
A Phase 3 study of Urinary Bladder Neoplasms, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 337
- Enrollment target
- 20
- Study locations
NCT00625664 is a Phase 3 study of Urinary Bladder Neoplasms that has completed, run by Sanofi. The registered enrollment target is 337 participants, above the 295-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT00625664, a Phase 3 study of Urinary Bladder Neoplasms, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 337 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
Conditions Studied
Interventions
- DRUG cisplatin
- DRUG gemcitabine
- DRUG larotaxel (XRP9881)
Study Locations (20)
California
- Sanofi-Aventis Investigational Site Number 840035 - Berkeley
- Sanofi-Aventis Investigational Site Number 840012 - Burbank
- Sanofi-Aventis Investigational Site Number 840029 - La Jolla
- Sanofi-Aventis Investigational Site Number 840046 - Los Angeles
- Sanofi-Aventis Investigational Site Number 840003 - Sacramento
- Sanofi-Aventis Investigational Site Number 840005 - San Bernardino
- Sanofi-Aventis Investigational Site Number 840033 - San Diego
Florida
- Sanofi-Aventis Investigational Site Number 840001 - Boca Raton
- Sanofi-Aventis Investigational Site Number 840048 - Boynton Beach
- Sanofi-Aventis Investigational Site Number 840049 - Jacksonville
- Sanofi-Aventis Investigational Site Number 840061 - Lakeland
District of Columbia
- Sanofi-Aventis Investigational Site Number 840034 - Washington D.C.
- Sanofi-Aventis Investigational Site Number 840021 - Washington D.C.
Illinois
- Sanofi-Aventis Investigational Site Number 840024 - Maywood
- Sanofi-Aventis Investigational Site Number 840062 - Peoria
Alaska
- Sanofi-Aventis Investigational Site Number 840068 - Anchorage
Colorado
- Sanofi-Aventis Investigational Site Number 840031 - Denver
Connecticut
- Sanofi-Aventis Investigational Site Number 840032 - Stamford
Georgia
- Sanofi-Aventis Investigational Site Number 840060 - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 337 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00625664
The ClinicalTrials.gov registry entry for NCT00625664 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 337 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 295-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (14% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which cisplatin is the first listed.
NCT00625664 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00625664 about?
NCT00625664 is a clinical study titled "Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer". This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondar...
What is the current status of trial NCT00625664?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 337 participants. The study started on 2008-02. Estimated completion is 2011-02.
What conditions does trial NCT00625664 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT00625664?
The interventions under investigation include: cisplatin (DRUG), gemcitabine (DRUG), larotaxel (XRP9881) (DRUG).
Who is sponsoring clinical trial NCT00625664?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00625664 being conducted?
This trial has 20 study locations across Alaska, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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