NCT00315237

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 7, 2010

Status Verified

January 1, 2010

Enrollment Period

2.5 years

First QC Date

April 14, 2006

Last Update Submit

January 6, 2010

Conditions

Transitional Cell Carcinoma of the Urothelial TractBladder CancerBladder Neoplasms

Outcome Measures

Primary Outcomes (1)

  • duration of Overall Survival after Randomization

    30-March-07

Secondary Outcomes (6)

  • patient benefit

    30-Mar-07

  • safety

    30-Mar-2007

  • response rate

    throughout the study

  • time to response

    upon occurrence

  • response duration

    throughout the study

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: vinflunine and best supportive care

2

NO INTERVENTION

best supportive care for 18 week duration

Interventions

vinflunine and best supportive careDRUG

solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bladder cancer
  • Progressed after 1st line platinum-chemotherapy
  • \>= 18 years old
  • Adequate hematologic, hepatic \& renal function

You may not qualify if:

  • CNS disease
  • Moderate neuropathy
  • More than 1 previous chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Local Institution

Calgary, Alberta, Canada

Location

Local Institution

Edmonton, Alberta, Canada

Location

Local Institution

Vancouver, British Columbia, Canada

Location

Local Institution

Victoria, British Columbia, Canada

Location

Local Institution

Brampton, Ontario, Canada

Location

Local Institution

Hamilton, Ontario, Canada

Location

Local Institution

Kingston, Ontario, Canada

Location

Local Institution

London, Ontario, Canada

Location

Local Institution

Toronto, Ontario, Canada

Location

Local Institution

Montreal, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29562804DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional CellUrinary Bladder Neoplasms

Interventions

vinflunine

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

July 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 7, 2010

Record last verified: 2010-01

Locations

CA(10)