|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00315237 |
|
Date of registration:
|
14/04/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
|
|
Scientific title:
|
Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract |
|
Date of first enrolment:
|
July 2005 |
|
Target sample size:
|
364 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00315237 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Bristol-Myers Squibb |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bristol-Myers Squibb |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Bladder cancer
- Progressed after 1st line platinum-chemotherapy
- >= 18 years old
- Adequate hematologic, hepatic & renal function
Exclusion Criteria:
- CNS disease
- Moderate neuropathy
- More than 1 previous chemotherapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Bladder Cancer
|
|
Bladder Neoplasms
|
|
Transitional Cell Carcinoma of the Urothelial Tract
|
|
Intervention(s)
|
|
Drug: vinflunine and best supportive care
|
|
Primary Outcome(s)
|
|
duration of Overall Survival after Randomization
[Time Frame: 30-March-07]
|
|
Secondary Outcome(s)
|
|
patient benefit
[Time Frame: 30-Mar-07]
|
|
progression free survival
[Time Frame: throughout the study]
|
|
response duration
[Time Frame: throughout the study]
|
|
response rate
[Time Frame: throughout the study]
|
|
safety
[Time Frame: 30-Mar-2007]
|
|
time to response
[Time Frame: upon occurrence]
|
|
Secondary ID(s)
|
|
CA183004
|
|
L0070 IN 302 P1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|