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vinflunine

Phase 2

Transitional Cell Carcinoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 2, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00101608Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the UrotheliumPHASE2 COMPLETED 150Jan 1, 2005Apr 1, 2007Mar 2, 201075 United States, Australia +13
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Study Endpoints
Primary Endpoints
To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.
10-Apr-2007
Secondary Endpoints
To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine
10-April-2007
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
vinflunineDRUGsolution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites75

Inclusion Criteria: * Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease). * Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemo...

Countries:United StatesAustraliaAustriaCanadaFranceGreeceIndonesiaItalyPhilippinesSingaporeSouth KoreaSpainSwedenSwitzerlandThailand
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