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Anti-metabolites
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Phase 2 & 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
Eligible Conditions
- Cancer
- Bladder Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)
Duration of Response in Participants With Best Response of CR or PR
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
+3 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: vinflunine and gemcitabineExperimental Treatment2 Interventions
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Group II: placebo and gemcitabinePlacebo Group2 Interventions
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinflunine
FDA approved
Gemcitabine
FDA approved
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,099,037 Total Patients Enrolled