The Effect of Using Pazopanib With Food vs. Fasted on Pharmacokinetics, Patient Safety, and Preference (DIET Study)

Clin Pharmacol Ther. 2019 Nov;106(5):1076-1082. doi: 10.1002/cpt.1515. Epub 2019 Jul 9.

Abstract

Pazopanib is taken fasted in a fixed oral daily dose of 800 mg. We hypothesized that ingesting pazopanib with food may improve patients' comfort and reduce gastrointestinal (GI) adverse events. Therefore, we investigated the bioequivalent dose of pazopanib when taken with food compared with 800 mg pazopanib taken fasted. In addition, we investigated the differences in GI toxicity, patient satisfaction, and patient's preference for either intake. The intake of 600 mg pazopanib with food resulted in a bioequivalent exposure and was preferred over a standard pazopanib dose without food. No differences were seen in GI toxicities under both intake regimens. Patients seem to be more positive about their feelings about side effects and satisfaction with their therapy when pazopanib was taken with food. Forty-one of the patients (68%) preferred the intake with a continental breakfast.

Trial registration: ClinicalTrials.gov NCT02138526.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / adverse effects
  • Angiogenesis Inhibitors / pharmacokinetics*
  • Area Under Curve
  • Dose-Response Relationship, Drug
  • Fasting
  • Female
  • Food-Drug Interactions / physiology
  • Half-Life
  • Humans
  • Indazoles
  • Male
  • Metabolic Clearance Rate
  • Middle Aged
  • Patient Preference*
  • Patient Safety*
  • Patient Satisfaction*
  • Pyrimidines / adverse effects
  • Pyrimidines / pharmacokinetics*
  • Sulfonamides / adverse effects
  • Sulfonamides / pharmacokinetics*
  • Young Adult

Substances

  • Angiogenesis Inhibitors
  • Indazoles
  • Pyrimidines
  • Sulfonamides
  • pazopanib

Associated data

  • ClinicalTrials.gov/NCT02138526