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First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

Primary Purpose

Bladder Cancer, Transitional Cell Carcinoma, Metastasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vinflunine
Gemcitabine
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Advanced or metastatic transitional cell carcinoma of the urothelium

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic

  • Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:

    • Calculated creatinine clearance ≤60 mL/min: OR
    • New York Heart Association Classification Stage III-IV Congestive Heart Failure
  • Measurable disease documented by imaging with at least one uni-dimensional lesion
  • Adequate performance status (ECOG 0, 1, or 2)
  • Men and women ≥18 years of age

Exclusion Criteria:

  • Patients in whom radiation or surgery is indicated
  • Current neuropathy ≥ CTCAE grade 3
  • Prior radiation to ≥ 30% of bone marrow
  • Inadequate renal function: serum creatinine clearance ≤ 20 mL/min
  • Prior allergy to any vinca alkaloid

Sites / Locations

  • University Of Alabama At Birmingham
  • Acrc/Arizona Clinical Research Center, Inc.
  • Tower Hematology Oncology Medical Group
  • Local Institution
  • Glendale Memorial Hospital And Health Center
  • Moores Ucsd Cancer Center
  • North Valley Hematology/Oncology Medical Group
  • Local Institution
  • Stanford University
  • Local Institution
  • University Of Florida College Of Medicine At Jacksonville
  • Local Institution
  • Lakeland Regional Cancer Center
  • University Of Miami
  • Advanced Medical Specialties
  • Medical College Of Georgia
  • Central Georgia Cancer Care, Pc
  • University Of Chicago
  • Springfield Clinic, Llp
  • Michiana Hematology Oncology, P.C.
  • James Graham Brown Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • Henry Ford Hospital
  • Mitchell Folbe, Md, Pc
  • Local Institution
  • Local Institution
  • Missouri Cancer Associates
  • University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
  • Capital Comprehensive Cancer Care Center
  • Kansas City Veterans Affairs Medical Center
  • Washington University School Of Medicine
  • Billings Clinic
  • Hematology Oncology Centers Of The Northern Rockies, Pc
  • Nevada Cancer Institute
  • Nevada Cancer Centers
  • The Cancer Center At Hackensack University Medical Center
  • Albert Einstein Cancer Center
  • The Mary Imogene Bassett Hospital
  • Columbia University Medical Center
  • New York Presbyterian Hospital
  • University Of Rochester
  • Carolinas Hematology Oncology Associates
  • Mid Dakota Clinic, Pc
  • Cleveland Clinic
  • Mid-Ohio Oncology/Hematology, Inc. Dba
  • Abramson Cancer Center Of The
  • Guthrie Foundation For Education And Research
  • Charleston Cancer Center
  • Medical University Of South Carolina
  • The Jones Clinic, Pc
  • The West Clinic
  • The Sarah Cannon Research Institute
  • Lone Star Oncology Consulants, Pa
  • Cancer Specialists Of South Texas, Pa
  • The Center For Cancer And Blood Disorders
  • University Of Texas Medical Branch Of Galveston
  • South Texas Oncology And Hematology, P.A.
  • Northern Utah Associates
  • Cancer Outreach Associates, Pc
  • Virginia Oncology Associates
  • Virginia Mason Medical Center
  • Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
  • West Virginia University
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vinflunine and gemcitabine

placebo and gemcitabine

Arm Description

solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration

solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

Outcomes

Primary Outcome Measures

Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium
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.

Secondary Outcome Measures

Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria
Tumor response rate is defined as the number of participants in that arm whose best response is PR or CR, divided by the total number of randomized participants in the arm.
Overall Survival of Participants With TCC of the Urothelium
Survival duration is defined as the time (in months) from randomization until death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)
Disease control rate is defined as the number of participants in that arm whose best response is PR, CR, or SD, divided by the total number of randomized participants in the treatment arm.
Duration of Response in Participants With Best Response of CR or PR
Duration of response is computed for participants with best response of CR or PR; the duration is measured from the time measurement criteria are met for CR or PR, whichever is recorded first, until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.
Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade
Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade
Time to Response in Participants With Best Response of CR or PR
Time to response is defined as the number of months from the first dose of study therapy until measurement criteria are met for PR or CR, whichever is recorded first.

Full Information

First Posted
October 17, 2006
Last Updated
November 6, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00389155
Brief Title
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Official Title
A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Carcinoma, Metastasis
Keywords
Advanced or metastatic transitional cell carcinoma of the urothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vinflunine and gemcitabine
Arm Type
Experimental
Arm Description
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Arm Title
placebo and gemcitabine
Arm Type
Placebo Comparator
Arm Description
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Intervention Type
Drug
Intervention Name(s)
Vinflunine
Intervention Description
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium
Description
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.
Time Frame
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Secondary Outcome Measure Information:
Title
Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria
Description
Tumor response rate is defined as the number of participants in that arm whose best response is PR or CR, divided by the total number of randomized participants in the arm.
Time Frame
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Title
Overall Survival of Participants With TCC of the Urothelium
Description
Survival duration is defined as the time (in months) from randomization until death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
Time Frame
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Title
Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)
Description
Disease control rate is defined as the number of participants in that arm whose best response is PR, CR, or SD, divided by the total number of randomized participants in the treatment arm.
Time Frame
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Title
Duration of Response in Participants With Best Response of CR or PR
Description
Duration of response is computed for participants with best response of CR or PR; the duration is measured from the time measurement criteria are met for CR or PR, whichever is recorded first, until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.
Time Frame
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Title
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
Description
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.
Time Frame
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Title
Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade
Time Frame
Following Day 1 to no longer than 30 days after last dose of study medication
Title
Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade
Time Frame
Following Day 1 to no longer than 30 days after last dose of study medication
Title
Time to Response in Participants With Best Response of CR or PR
Description
Time to response is defined as the number of months from the first dose of study therapy until measurement criteria are met for PR or CR, whichever is recorded first.
Time Frame
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions: Calculated creatinine clearance ≤60 mL/min: OR New York Heart Association Classification Stage III-IV Congestive Heart Failure Measurable disease documented by imaging with at least one uni-dimensional lesion Adequate performance status (ECOG 0, 1, or 2) Men and women ≥18 years of age Exclusion Criteria: Patients in whom radiation or surgery is indicated Current neuropathy ≥ CTCAE grade 3 Prior radiation to ≥ 30% of bone marrow Inadequate renal function: serum creatinine clearance ≤ 20 mL/min Prior allergy to any vinca alkaloid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Acrc/Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Local Institution
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Glendale Memorial Hospital And Health Center
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Moores Ucsd Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
North Valley Hematology/Oncology Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Local Institution
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Local Institution
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
University Of Florida College Of Medicine At Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
University Of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Advanced Medical Specialties
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Medical College Of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Central Georgia Cancer Care, Pc
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Springfield Clinic, Llp
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Michiana Hematology Oncology, P.C.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mitchell Folbe, Md, Pc
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Local Institution
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Local Institution
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Capital Comprehensive Cancer Care Center
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Kansas City Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Washington University School Of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology Oncology Centers Of The Northern Rockies, Pc
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Nevada Cancer Centers
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
The Cancer Center At Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
The Mary Imogene Bassett Hospital
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Carolinas Hematology Oncology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Mid Dakota Clinic, Pc
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Mid-Ohio Oncology/Hematology, Inc. Dba
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Abramson Cancer Center Of The
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Guthrie Foundation For Education And Research
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Medical University Of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The Jones Clinic, Pc
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Lone Star Oncology Consulants, Pa
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Cancer Specialists Of South Texas, Pa
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
The Center For Cancer And Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University Of Texas Medical Branch Of Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
South Texas Oncology And Hematology, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Cancer Outreach Associates, Pc
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Local Institution
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Local Institution
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Local Institution
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4MI
Country
Canada
Facility Name
Local Institution
City
Arhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution
City
Kobenhavn O
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Caen Cedex 05
ZIP/Postal Code
14076
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Local Institution
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Facility Name
Local Institution
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
Local Institution
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Local Institution
City
Seongnam
State/Province
Gyeonggi-Do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Local Institution
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Local Institution
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Local Institution
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Local Institution
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Local Institution
City
Cracow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Local Institution
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
61-878-
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Obninsk
State/Province
Kaluga Region
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Local Institution
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Local Institution
City
Palma De Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Local Institution
City
Sabadell (Barcelona)
ZIP/Postal Code
08208
Country
Spain
Facility Name
Local Institution
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Local Institution
City
Cardiff
State/Province
Glamorgan
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Local Institution
City
Grimsby
State/Province
Lincolnshire
ZIP/Postal Code
DN332BA
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG51PB
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

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