A Phase 2/3 interventional study of Vinflunine and Gemcitabine in Bladder Cancer, Transitional Cell Carcinoma and Metastasis, sponsored by Bristol-Myers Squibb. Completed at 112 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-07.
Sponsored by Bristol-Myers Squibb · Phase 2/3, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 34 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
Exclusion Criteria:
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Drug: Vinflunine · Drug: Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Drug: Gemcitabine · Other: Placebo
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
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
PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria
Tumor response rate is defined as the number of participants in that arm whose best response is PR or CR, divided by the total number of randomized participants in the arm.
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Overall Survival of Participants With TCC of the Urothelium
Survival duration is defined as the time (in months) from randomization until death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)
Disease control rate is defined as the number of participants in that arm whose best response is PR, CR, or SD, divided by the total number of randomized participants in the treatment arm.
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Duration of Response in Participants With Best Response of CR or PR
Duration of response is computed for participants with best response of CR or PR; the duration is measured from the time measurement criteria are met for CR or PR, whichever is recorded first, until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade
Time frame: Following Day 1 to no longer than 30 days after last dose of study medication
Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade
Time frame: Following Day 1 to no longer than 30 days after last dose of study medication
Time to Response in Participants With Best Response of CR or PR
Time to response is defined as the number of months from the first dose of study therapy until measurement criteria are met for PR or CR, whichever is recorded first.
Time frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Showing the first 100 of 112 sites across 16 countries.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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