Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Urinary Bladder Neoplasms, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00625664 record still lists
NCT00625664 is an interventional study that assigns participants to a tested intervention. The registered 337 participants enrollment target is mid-sized for trials with a published cap, above the 295-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (14% higher).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Urinary Bladder Neoplasms
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 NCT00625664's enrollment target sits among peer trials
337 8th of 19 higher than 12 of 19 other Urinary Bladder Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Bladder Neoplasms 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
RECRUITING · Phase 3
-
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
ACTIVE NOT RECRUITING · Phase 3
-
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
ACTIVE NOT RECRUITING · Phase 3
-
FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
RECRUITING · Phase 1
-
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03253263 · 338 participants · Phase 2
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
- NCT05658731 · 338 participants · NA
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
- NCT06022939 · 338 participants · Phase 3
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
- NCT03947385 · 336 participants · Phase 1
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia