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

Primary Purpose

Urinary Bladder Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
larotaxel (XRP9881)
gemcitabine
cisplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring Cancer, Neoplasms, Bladder, Urothelial Tract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
  • ECOG Performance Status 0 or 1
  • No prior palliative chemotherapy

Exclusion Criteria:

  • (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse
  • Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
  • Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m²

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sanofi-Aventis Investigational Site Number 840068
  • Sanofi-Aventis Investigational Site Number 840035
  • Sanofi-Aventis Investigational Site Number 840012
  • Sanofi-Aventis Investigational Site Number 840029
  • Sanofi-Aventis Investigational Site Number 840046
  • Sanofi-Aventis Investigational Site Number 840003
  • Sanofi-Aventis Investigational Site Number 840005
  • Sanofi-Aventis Investigational Site Number 840033
  • Sanofi-Aventis Investigational Site Number 840031
  • Sanofi-Aventis Investigational Site Number 840032
  • Sanofi-Aventis Investigational Site Number 840034
  • Sanofi-Aventis Investigational Site Number 840021
  • Sanofi-Aventis Investigational Site Number 840001
  • Sanofi-Aventis Investigational Site Number 840048
  • Sanofi-Aventis Investigational Site Number 840049
  • Sanofi-Aventis Investigational Site Number 840061
  • Sanofi-Aventis Investigational Site Number 840060
  • Sanofi-Aventis Investigational Site Number 840030
  • Sanofi-Aventis Investigational Site Number 840024
  • Sanofi-Aventis Investigational Site Number 840062
  • Sanofi-Aventis Investigational Site Number 840039
  • Sanofi-Aventis Investigational Site Number 840054
  • Sanofi-Aventis Investigational Site Number 840057
  • Sanofi-Aventis Investigational Site Number 840004
  • Sanofi-Aventis Investigational Site Number 840045
  • Sanofi-Aventis Investigational Site Number 840006
  • Sanofi-Aventis Investigational Site Number 840026
  • Sanofi-Aventis Investigational Site Number 840047
  • Sanofi-Aventis Investigational Site Number 840009
  • Sanofi-Aventis Investigational Site Number 840044
  • Sanofi-Aventis Investigational Site Number 840013
  • Sanofi-Aventis Investigational Site Number 840050
  • Sanofi-Aventis Investigational Site Number 840056
  • Sanofi-Aventis Investigational Site Number 840015
  • Sanofi-Aventis Investigational Site Number 840041
  • Sanofi-Aventis Investigational Site Number 840007
  • Sanofi-Aventis Investigational Site Number 840019
  • Sanofi-Aventis Investigational Site Number 840020
  • Sanofi-Aventis Investigational Site Number 840065
  • Sanofi-Aventis Investigational Site Number 840058
  • Sanofi-Aventis Investigational Site Number 840052
  • Sanofi-Aventis Investigational Site Number 840002
  • Sanofi-Aventis Investigational Site Number 840008
  • Sanofi-Aventis Investigational Site Number 840018
  • Sanofi-Aventis Investigational Site Number 840017
  • Sanofi-Aventis Investigational Site Number 840016
  • Sanofi-Aventis Investigational Site Number 840064
  • Sanofi-Aventis Investigational Site Number 840010
  • Sanofi-Aventis Investigational Site Number 840036
  • Sanofi-Aventis Investigational Site Number 840011
  • Sanofi-Aventis Investigational Site Number 840025
  • Sanofi-Aventis Investigational Site Number 840038
  • Sanofi-Aventis Investigational Site Number 032002
  • Sanofi-Aventis Investigational Site Number 032003
  • Sanofi-Aventis Investigational Site Number 032004
  • Sanofi-Aventis Investigational Site Number 032005
  • Sanofi-Aventis Investigational Site Number 032001
  • Sanofi-Aventis Investigational Site Number 036002
  • Sanofi-Aventis Investigational Site Number 036003
  • Sanofi-Aventis Investigational Site Number 036004
  • Sanofi-Aventis Investigational Site Number 056005
  • Sanofi-Aventis Investigational Site Number 056001
  • Sanofi-Aventis Investigational Site Number 056002
  • Sanofi-Aventis Investigational Site Number 056004
  • Sanofi-Aventis Investigational Site Number 056003
  • Sanofi-Aventis Investigational Site Number 056006
  • Sanofi-Aventis Investigational Site Number 076006
  • Sanofi-Aventis Investigational Site Number 076004
  • Sanofi-Aventis Investigational Site Number 076001
  • Sanofi-Aventis Investigational Site Number 076003
  • Sanofi-Aventis Investigational Site Number 076002
  • Sanofi-Aventis Investigational Site Number 076007
  • Sanofi-Aventis Investigational Site Number 076005
  • Sanofi-Aventis Investigational Site Number 124007
  • Sanofi-Aventis Investigational Site Number 124001
  • Sanofi-Aventis Investigational Site Number 124006
  • Sanofi-Aventis Investigational Site Number 124003
  • Sanofi-Aventis Investigational Site Number 124002
  • Sanofi-Aventis Investigational Site Number 152001
  • Sanofi-Aventis Investigational Site Number 250006
  • Sanofi-Aventis Investigational Site Number 250003
  • Sanofi-Aventis Investigational Site Number 250005
  • Sanofi-Aventis Investigational Site Number 250011
  • Sanofi-Aventis Investigational Site Number 250004
  • Sanofi-Aventis Investigational Site Number 250012
  • Sanofi-Aventis Investigational Site Number 250007
  • Sanofi-Aventis Investigational Site Number 250008
  • Sanofi-Aventis Investigational Site Number 250009
  • Sanofi-Aventis Investigational Site Number 250001
  • Sanofi-Aventis Investigational Site Number 356003
  • Sanofi-Aventis Investigational Site Number 356007
  • Sanofi-Aventis Investigational Site Number 356004
  • Sanofi-Aventis Investigational Site Number 356001
  • Sanofi-Aventis Investigational Site Number 356002
  • Sanofi-Aventis Investigational Site Number 356005
  • Sanofi-Aventis Investigational Site Number 376005
  • Sanofi-Aventis Investigational Site Number 376004
  • Sanofi-Aventis Investigational Site Number 376003
  • Sanofi-Aventis Investigational Site Number 376002
  • Sanofi-Aventis Investigational Site Number 376007
  • Sanofi-Aventis Investigational Site Number 376001
  • Sanofi-Aventis Investigational Site Number 380004
  • Sanofi-Aventis Investigational Site Number 380003
  • Sanofi-Aventis Investigational Site Number 380005
  • Sanofi-Aventis Investigational Site Number 380006
  • Sanofi-Aventis Investigational Site Number 380002
  • Sanofi-Aventis Investigational Site Number 380001
  • Sanofi-Aventis Investigational Site Number 380008
  • Sanofi-Aventis Investigational Site Number 484003
  • Sanofi-Aventis Investigational Site Number 484007
  • Sanofi-Aventis Investigational Site Number 484005
  • Sanofi-Aventis Investigational Site Number 484004
  • Sanofi-Aventis Investigational Site Number 528005
  • Sanofi-Aventis Investigational Site Number 528002
  • Sanofi-Aventis Investigational Site Number 528006
  • Sanofi-Aventis Investigational Site Number 528003
  • Sanofi-Aventis Investigational Site Number 528004
  • Sanofi-Aventis Investigational Site Number 528001
  • Sanofi-Aventis Investigational Site Number 528007
  • Sanofi-Aventis Investigational Site Number 616002
  • Sanofi-Aventis Investigational Site Number 616004
  • Sanofi-Aventis Investigational Site Number 616001
  • Sanofi-Aventis Investigational Site Number 616005
  • Sanofi-Aventis Investigational Site Number 643009
  • Sanofi-Aventis Investigational Site Number 643010
  • Sanofi-Aventis Investigational Site Number 643006
  • Sanofi-Aventis Investigational Site Number 643008
  • Sanofi-Aventis Investigational Site Number 643004
  • Sanofi-Aventis Investigational Site Number 643005
  • Sanofi-Aventis Investigational Site Number 643001
  • Sanofi-Aventis Investigational Site Number 643003
  • Sanofi-Aventis Investigational Site Number 643007
  • Sanofi-Aventis Investigational Site Number 643002
  • Sanofi-Aventis Investigational Site Number 643011
  • Sanofi-Aventis Investigational Site Number 710008
  • Sanofi-Aventis Investigational Site Number 710003
  • Sanofi-Aventis Investigational Site Number 710001
  • Sanofi-Aventis Investigational Site Number 710007
  • Sanofi-Aventis Investigational Site Number 710009
  • Sanofi-Aventis Investigational Site Number 710006
  • Sanofi-Aventis Investigational Site Number 710005
  • Sanofi-Aventis Investigational Site Number 724006
  • Sanofi-Aventis Investigational Site Number 724001
  • Sanofi-Aventis Investigational Site Number 724004
  • Sanofi-Aventis Investigational Site Number 724008
  • Sanofi-Aventis Investigational Site Number 724002
  • Sanofi-Aventis Investigational Site Number 724003
  • Sanofi-Aventis Investigational Site Number 724010
  • Sanofi-Aventis Investigational Site Number 724013
  • Sanofi-Aventis Investigational Site Number 724007
  • Sanofi-Aventis Investigational Site Number 724009
  • Sanofi-Aventis Investigational Site Number 724011
  • Sanofi-Aventis Investigational Site Number 724012
  • Sanofi-Aventis Investigational Site Number 752001
  • Sanofi-Aventis Investigational Site Number 752002
  • Sanofi-Aventis Investigational Site Number 792002
  • Sanofi-Aventis Investigational Site Number 792003
  • Sanofi-Aventis Investigational Site Number 792004
  • Sanofi-Aventis Investigational Site Number 792006
  • Sanofi-Aventis Investigational Site Number 792001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Overall survival defined as the time interval from the date of randomization to the date of death due to any cause

Secondary Outcome Measures

Radiological tumor assessments (CT/MRI)
Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status

Full Information

First Posted
February 19, 2008
Last Updated
April 6, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00625664
Brief Title
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Acronym
CILAB
Official Title
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms
Keywords
Cancer, Neoplasms, Bladder, Urothelial Tract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
larotaxel (XRP9881)
Intervention Description
administered on day 1 as a 1-hour infusion
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
administered on day 1, 8 and 15 as a 30-minute infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
1 hour infusion administered on day 1, 30 minutes after the other treatment
Primary Outcome Measure Information:
Title
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Time Frame
study period
Secondary Outcome Measure Information:
Title
Radiological tumor assessments (CT/MRI)
Time Frame
at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
Title
Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status
Time Frame
at screening and every cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer ECOG Performance Status 0 or 1 No prior palliative chemotherapy Exclusion Criteria: (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m² The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Investigational Site Number 840068
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840035
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840012
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840029
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840046
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840003
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840005
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840033
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840031
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840032
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840034
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840021
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840001
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840048
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840049
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840061
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840060
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840030
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840024
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840062
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840039
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840054
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7321
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840057
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42002
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840004
City
Metarie
State/Province
Louisiana
ZIP/Postal Code
70006-290
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840045
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840006
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840026
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48510
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840047
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49805
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840009
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840044
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840013
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840050
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840056
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840015
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840041
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840007
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840019
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840020
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840065
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840058
City
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840052
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840002
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840008
City
Houston
State/Province
Texas
ZIP/Postal Code
77014
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840018
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840017
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840016
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840064
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840010
City
Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840036
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840011
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840025
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840038
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 032002
City
Buenos Aires
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Sanofi-Aventis Investigational Site Number 032003
City
Ciudad De Buenos Aires
ZIP/Postal Code
C1426BOR
Country
Argentina
Facility Name
Sanofi-Aventis Investigational Site Number 032004
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Sanofi-Aventis Investigational Site Number 032005
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanofi-Aventis Investigational Site Number 032001
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Sanofi-Aventis Investigational Site Number 036002
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Sanofi-Aventis Investigational Site Number 036003
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Sanofi-Aventis Investigational Site Number 036004
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sanofi-Aventis Investigational Site Number 056005
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056001
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056002
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056004
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056003
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056006
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 076006
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076004
City
Florianopolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076001
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076003
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076002
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076007
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076005
City
Sao Paulo
ZIP/Postal Code
04122 000
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 124007
City
Edmonton
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124001
City
London
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124006
City
Montreal
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124003
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124002
City
Weston
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 152001
City
Santiago
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 250006
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250003
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250005
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250011
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250004
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250012
City
Perpignan
ZIP/Postal Code
66012
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250007
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250008
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250009
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250001
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 356003
City
Bangalore
ZIP/Postal Code
560029
Country
India
Facility Name
Sanofi-Aventis Investigational Site Number 356007
City
Kolkata
ZIP/Postal Code
700026
Country
India
Facility Name
Sanofi-Aventis Investigational Site Number 356004
City
New Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Sanofi-Aventis Investigational Site Number 356001
City
New Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Sanofi-Aventis Investigational Site Number 356002
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Sanofi-Aventis Investigational Site Number 356005
City
Vishakhapatnam
ZIP/Postal Code
530002
Country
India
Facility Name
Sanofi-Aventis Investigational Site Number 376005
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Sanofi-Aventis Investigational Site Number 376004
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Sanofi-Aventis Investigational Site Number 376003
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sanofi-Aventis Investigational Site Number 376002
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sanofi-Aventis Investigational Site Number 376007
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sanofi-Aventis Investigational Site Number 376001
City
Tzrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Sanofi-Aventis Investigational Site Number 380004
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380003
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380005
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380006
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380002
City
Perugia
ZIP/Postal Code
06128
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380001
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 380008
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Sanofi-Aventis Investigational Site Number 484003
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Sanofi-Aventis Investigational Site Number 484007
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Sanofi-Aventis Investigational Site Number 484005
City
Chihuahua
ZIP/Postal Code
31205
Country
Mexico
Facility Name
Sanofi-Aventis Investigational Site Number 484004
City
Monterrey
ZIP/Postal Code
64988
Country
Mexico
Facility Name
Sanofi-Aventis Investigational Site Number 528005
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528002
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528006
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528003
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528004
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528001
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 528007
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 616002
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Sanofi-Aventis Investigational Site Number 616004
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Sanofi-Aventis Investigational Site Number 616001
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Sanofi-Aventis Investigational Site Number 616005
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Sanofi-Aventis Investigational Site Number 643009
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643010
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643006
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643008
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643004
City
Moscow
ZIP/Postal Code
117837
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643005
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643001
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643003
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643007
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643002
City
St-Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643011
City
St-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 710008
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710003
City
Cape Town
ZIP/Postal Code
7506
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710001
City
Cape Town
ZIP/Postal Code
7956
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710007
City
Durban
ZIP/Postal Code
4062
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710009
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710006
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710005
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 724006
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724001
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724004
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724008
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724002
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724003
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724010
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724013
City
Palma De Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724007
City
Palma De Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724009
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724011
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 724012
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Sanofi-Aventis Investigational Site Number 752001
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Sanofi-Aventis Investigational Site Number 752002
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Sanofi-Aventis Investigational Site Number 792002
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Sanofi-Aventis Investigational Site Number 792003
City
Ankara
ZIP/Postal Code
065090
Country
Turkey
Facility Name
Sanofi-Aventis Investigational Site Number 792004
City
Ankara
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Sanofi-Aventis Investigational Site Number 792006
City
Istanbul
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Sanofi-Aventis Investigational Site Number 792001
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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