Phase I and pharmacokinetic study of IV vinflunine in cancer patients with liver dysfunction

JP Delord, A Ravaud, J Bennouna, P Fumoleau… - Investigational new …, 2013 - Springer
Vinflunine is a novel tubulin-targeted agent that is currently indicated as a monotherapy in
bladder cancer patients. The recommended dose of 320 mg/m 2 is given as an intravenous
infusion once every 3 weeks. Vinflunine is metabolized through CYP3A4 and mainly
eliminated via the feces. A phase I trial was designed to explore the tolerability and
pharmacokinetics of vinflunine in cancer patients with ranging degrees of liver dysfunction
(LD). A sequential design was used for patient accrual, with the objective of determining the …
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