Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
NCT ID: NCT00315237
Last Updated: 2010-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
364 participants
INTERVENTIONAL
2005-07-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
vinflunine and best supportive care
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
2
best supportive care for 18 week duration
No interventions assigned to this group
Interventions
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vinflunine and best supportive care
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
Eligibility Criteria
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Inclusion Criteria
* Progressed after 1st line platinum-chemotherapy
* \>= 18 years old
* Adequate hematologic, hepatic \& renal function
Exclusion Criteria
* Moderate neuropathy
* More than 1 previous chemotherapy
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local Institution
Brampton, Ontario, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Kingston, Ontario, Canada
Local Institution
London, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Countries
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References
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Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.
Other Identifiers
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CA183004
Identifier Type: -
Identifier Source: secondary_id
L0070 IN 302 P1
Identifier Type: -
Identifier Source: org_study_id
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