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vinflunine + ketaconazole

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 19, 2016

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 Trials2
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00362830A Study of the Alternative Administration of Ixabepilone and VinfluninePHASE1 COMPLETED 60Aug 1, 2006Sep 1, 2007Sep 19, 20162 United States
NCT00388557Effect of Ketoconazole on the Pharmacokinetics of VinfluninePHASE1 COMPLETED 35Oct 1, 2005Sep 1, 2007Sep 19, 20161 United States
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Study Endpoints
Primary Endpoints
Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.
upon occurrence
To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected
Days 1 through 5 and Day 8 of Cycles 1 and 2
Secondary Endpoints
Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body.
upon occurrence
Evaluate the safety of vinflunine co-administered with ketoconazole and assess the safety of vinflunine in patients with advanced cancer. Safety laboratory assessments and evaluations will be collected
weekly
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
vinflunine + ixabepiloneDRUGsolution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration
vinflunine + ketaconazoleDRUGvinflunine solution for injection, ketaconazole tablets, vinflunine IV, ketaconazole oral, vinflunine 80 to 320mg/m2 + ketaconazole 400 mg, vinflunine every 3 wks, ketaconazole C1 only, variable duration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * ECOG status of 0-1 Exclusion Criteria: * Inability to tolerate venous access * Brain mets * Severe nerve damage * ANC \<2,000/mm3 * Platelets \<100K * Bilirubin \>= 1.5 times the IULN * ALT/AST \>= 2.5 times the IULN * Creatinine \<50 mL/min * Prior treatment with vinflunine...

Countries:United States
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