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COMPLETED Phase 3

Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

NCT00625664 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 337 participants
Start Date 2008-02
Est. Completion 2011-02
Phase Phase 3

Sponsor

Sanofi

275 total trials

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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. It is categorized as Phase 3, 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 337 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT00625664 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, District of Columbia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00625664?

The interventions under investigation include: cisplatin (DRUG), gemcitabine (DRUG), larotaxel (XRP9881) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00625664?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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