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
… of this phase I study were to investigate the pharmacokinetics and … This study aimed at
exploring PK and tolerability of iv vinflunine in cancer patients with varying degrees of chronic liver

Phase I and pharmacokinetic (PK) dose-adjusted study of IV vinflunine (VFL) in cancer patients with liver dysfunction (LD): Pharmacokinetic results

B Paule, F Saliba, M Gil-Delgado, C Puozzo… - … of Clinical Oncology, 2007 - ascopubs.org
… groups and a control group of 49 patients without LD enrolled in phase I trials). Results: …
Conclusions: The results showed that vinflunine and DVFL pharmacokinetic parameters do …

How to manage intravenous vinflunine in cancer patients with renal impairment: results of a pharmacokinetic and tolerability phase I study

N Isambert, JP Delord, JM Tourani… - British Journal of …, 2014 - Wiley Online Library
… Group (ECOG) performance status (PS) ≤ 2, no severe or uncontrolled medical conditions,
adequate haematologic count, no severe liver impairment according to international …

Phase I/II and Pharmacokinetic Study of Intravenous Vinflunine in Combination With Cisplatin for the Treatment of Chemonaive Patients With Advanced Non–Small …

PJ Souquet, M Krzakowski, R Ramlau, XS Sun… - Clinical lung cancer, 2010 - Elsevier
… This study was a noncomparative phase I/II trial. The primary objective of the phase I study
was to establish the recommended dose of the combination of vinflunine with cisplatin 80 mg/…

[HTML][HTML] Phase I and pharmacokinetic study of the new vinca alkaloid vinflunine administered as a 10-min infusion every 3 weeks in patients with advanced solid …

J Bennouna, P Fumoleau, JP Armand, E Raymond… - Annals of oncology, 2003 - Elsevier
Patients and methods In this phase I study, vinflunine was administered to 31 patients with
advanced malignancies as a 10-min iv infusion every 3 weeks according to an escalating …

Influence of age on the pharmacokinetics of iv vinflunine: results of a phase I trial in elderly cancer patients

JM Tourani, L Mourey, V Servent, T Nguyen… - … of Geriatric Oncology, 2012 - Elsevier
… In a phase I study 21 in renal impaired patients, VFL Cl tot was shown to be reduced in patients
… The original design used in the present study, enabled maximizing the antitumor effects …

[HTML][HTML] … I and pharmacokinetic study of IV vinflunine in combination with gemcitabine for treatment of advanced non-small cell lung cancer in chemonaive patients

C Tournoux-Facon, H Senellart, E Lemarie… - … of Thoracic Oncology, 2011 - Elsevier
… The primary objective of the study was to establish the recommended dose (RD) of … In this
study, 19 patients received a total of 80 cycles of the combination of vinflunine and gemcitabine…

[HTML][HTML] Vinflunine: a new active drug for second-line treatment of advanced breast cancer. Results of a phase II and pharmacokinetic study in patients progressing …

M Campone, H Cortes-Funes, D Vorobiof… - … journal of cancer, 2006 - nature.com
… Moreover, in the first Phase I study, two out of three patients with heavily pretreated MBC …
candidate for further investigation in patients with MBC. Vinflunine treatment every 3 weeks was …

A phase I clinical and pharmacokinetic study evaluating vinflunine in combination with epirubicin as first-line treatment in metastatic breast cancer

S Chan, M Campone, A Santoro, PF Conte… - Cancer chemotherapy …, 2014 - Springer
… in advanced stage breast cancer. We conducted a phase I study combining VFL with epirubicin
(… profiles and to investigate potential pharmacokinetic (PK) drug–drug interaction (DDI). …

Better characterization of vinflunine pharmacokinetics variability and exposure/toxicity relationship to improve its use: Analyses from 18 trials

A Schmitt, L Nguyen, G Zorza, P Ferré… - British journal of …, 2018 - Wiley Online Library
… For the special population Phase I studies, a rich-sampling blood collection … patient on
Cycle 1 for the liver dysfunction study and on Cycle 1 and Cycle 2 for the renal impairment study. …