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vinflunine+ ketaconazole

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

vinflunine+ ketaconazole · 2 trials · 1 indication

Phase 1 2
NCT00362830A Study of the Alternative Administration of Ixabepilone and VinflunineCancer
COMPLETED60 Analytics
NCT00388557Effect of Ketoconazole on the Pharmacokinetics of VinflunineCancer
COMPLETED35 Analytics
PHASE1COMPLETED
A Study of the Alternative Administration of Ixabepilone and Vinflunine
CancerUnlock trial analytics
PHASE1COMPLETED
Effect of Ketoconazole on the Pharmacokinetics of Vinflunine
CancerUnlock trial analytics

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 to 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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Frequently asked questions about vinflunine+ ketaconazole

What is Vinflunine used for?

Vinflunine is an investigational small molecule being studied for the treatment of several cancers, including breast cancer, bladder cancer, prostate cancer, small cell carcinoma, and transitional cell carcinoma. It is in Phase 2 clinical development and has not been approved by the FDA.

Who makes Vinflunine?

Vinflunine is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.

What phase is Vinflunine in?

Vinflunine is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. All completed trials for Vinflunine are Phase 2 studies, and there are no active trials currently ongoing.

What clinical trials is Vinflunine in?

Vinflunine has been studied in several Phase 2 clinical trials, including NCT00101608 for transitional cell carcinoma of the urothelium, NCT00284154 for relapsed extensive small cell lung cancer, NCT00284180 for HER2-overexpressing metastatic breast cancer, and NCT00389155 for advanced bladder cancer.

How does Vinflunine work?

Vinflunine is a small molecule that works by targeting microtubules, which are essential for cell division. By interfering with microtubule dynamics, it disrupts cancer cell proliferation. This mechanism is typical of vinca alkaloid class drugs used in oncology.