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Pharmacokinetics of phenoxodiol, a novel isoflavone, following intravenous administration to patients with advanced cancer.

AbstractBACKGROUND:
Phenoxodiol is a novel isoflavone currently being studied in clinical trials for the treatment of cancer. This study reports the pharmacokinetics of phenoxodiol in patients with cancer.
METHODS:
The pharmacokinetics of phenoxodiol was studied following a single intravenous (iv) bolus dose and during a continuous intravenous infusion. Three men with prostate cancer and 3 women with breast cancer received IV bolus phenoxodiol (5 mg/kg) and plasma was sampled for free and total phenoxodiol levels. On a separate occasion 5 of the same patients received a continuous intravenous infusion of phenoxodiol (2 mg/kg/h) and plasma was again sampled for free and total phenoxodiol levels. Phenoxodiol was measured using gradient HPLC with ultraviolet detection.
RESULTS:
Following bolus injection, free and total phenoxodiol appeared to follow first order pharmacokinetics. The elimination half-lives for free and total phenoxodiol were 0.67 ± 0.53 h and 3.19 ± 1.93 h, respectively, while the total plasma clearance rates were 2.48 ± 2.33 L/h and 0.15 ± 0.08 L/h, respectively. The respective apparent volumes of distribution were 1.55 ± 0.69 L/kg and 0.64 ± 0.51 L/kg. During continuous intravenous infusion, free phenoxodiol accumulated rapidly to reach a mean concentration at steady state of 0.79 ± 0.14 μg/ml after 0.87 ± 0.18 h. The apparent accumulation half-life of free phenoxodiol was 0.17 ± 0.04 h while the plasma clearance during continuous infusion was 1.29 ± 0.23 L/h.
CONCLUSIONS:
Phenoxodiol has a short plasma half-life, particularly in the free form, leading to a rapid attainment of steady state levels during continuous intravenous infusion.
TRIAL REGISTRATION:
Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000334000.
AuthorsJan B Howes, Paul L de Souza, Leanne West, Li Jiu Huang, Laurence G Howes
JournalBMC clinical pharmacology (BMC Clin Pharmacol) Vol. 11 Pg. 1 (Feb 03 2011) ISSN: 1472-6904 [Electronic] England
PMID21291562 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Isoflavones
  • phenoxodiol
Topics
  • Adolescent
  • Adult
  • Aged
  • Australia
  • Breast Neoplasms (drug therapy, metabolism)
  • Female
  • Half-Life
  • Humans
  • Infusions, Intravenous
  • Isoflavones (administration & dosage, adverse effects, pharmacokinetics)
  • Male
  • Middle Aged
  • New Zealand
  • Prostatic Neoplasms (drug therapy, metabolism)
  • Young Adult

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