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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00315237
Other study ID # L0070 IN 302 P1
Secondary ID CA183004
Status Completed
Phase Phase 3
First received April 14, 2006
Last updated January 6, 2010
Start date July 2005
Est. completion date January 2008

Study information

Verified date January 2010
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.


Recruitment information / eligibility

Status Completed
Enrollment 364
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
vinflunine and best supportive care
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration

Locations

Country Name City State
Canada Local Institution Brampton Ontario
Canada Local Institution Calgary Alberta
Canada Local Institution Edmonton Alberta
Canada Local Institution Hamilton Ontario
Canada Local Institution Kingston Ontario
Canada Local Institution London Ontario
Canada Local Institution Montreal Quebec
Canada Local Institution Toronto Ontario
Canada Local Institution Vancouver British Columbia
Canada Local Institution Victoria British Columbia

Sponsors (2)

Lead Sponsor Collaborator
Pierre Fabre Medicament Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary duration of Overall Survival after Randomization 30-March-07 No
Secondary patient benefit 30-Mar-07 No
Secondary safety 30-Mar-2007 Yes
Secondary response rate throughout the study No
Secondary time to response upon occurrence No
Secondary response duration throughout the study No
Secondary progression free survival throughout the study No
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