NDLI: A phase I study of the pharmacokinetic and safety profiles of oral pazopanib with a high-fat or low-fat meal in patients with advanced solid tumors.

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A phase I study of the pharmacokinetic and safety profiles of oral pazopanib with a high-fat or low-fat meal in patients with advanced solid tumors.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Heath, E. I. Chiorean, E. G. Sweeney, C. J. Hodge, J. P. Lager, J. J. Forman, K. Malburg, L. Arumugham, T. Dar, M. M. Suttle, A. B. Gainer, S. D. LoRusso, P.
Description	Country affiliation: United States Author Affiliation: Heath EI ( Karmanos Cancer Institute, Department of Oncology, Wayne State University, Detroit, Michigan, USA. heathe@karmanos.org)
Abstract	Pazopanib is an oral angiogenesis inhibitor of vascular endothelial growth factor (VEGF) receptor, platelet-derived growth factor receptor, and cytokine receptor. This open-label, randomized, crossover, phase I study evaluated the effect of low- and high-fat meals on the pharmacokinetics (PK) of pazopanib in patients with advanced solid tumors. Patients participated in either the lead-in cohort or randomized food-effect cohort. Patients in the lead-in cohort were administered a single dose of pazopanib 400 mg with a high-fat meal. Patients in the food-effect cohort were randomized to receive single doses of pazopanib 800 mg in fed condition (high- or low-fat meal) or fasting condition, in random sequence 14 days apart. After completion of the study, patients were given the opportunity to continue treatment with daily pazopanib 800 mg. Administration of pazopanib with both low- and high-fat meals increased maximum observed plasma concentration (C(max)) and area under the plasma concentration-time curve (AUC) by approximately twofold as compared with the corresponding values when administered to patients in the fasted condition. Therefore, pazopanib should be administered to patients in the fasted state so as to minimize within- and between-day variability in the systemic exposure to pazopanib in patients with cancer.
File Format	HTM / HTML
ISSN	00099236
Issue Number	6
Volume Number	88
e-ISSN	15326535
Journal	Clinical Pharmacology & Therapeutics
Language	English
Publisher	Wiley
Publisher Date	2010-12-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Dietary Fats Metabolism Food-drug Interactions Physiology Neoplasms Pyrimidines Adverse Effects Pharmacokinetics Sulfonamides Administration, Oral Adult Aged Cohort Studies Cross-over Studies Fatigue Chemically Induced Female Humans Hypertension Male Middle Aged Drug Therapy Administration & Dosage Clinical Trial, Phase I Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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