A Pharmacokinetic Study of Genistein, a Tyrosine Kinase Inhibitor
Genistein is a natural product found in soy beans; its consumption has been associated with
a low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase
inhibitor, and in preclinical studies it has been shown to increase cell adhesion.
Increases in cell adhesion in vivo would phenotypically reverse the first step in the
metastatic cascade, potentially preventing metastasis formation, and is consistent with
epidemiologic findings. This study seeks to determine the pharmacokinetics of genistein in
humans by administering a single dose of genistein and performing a pharmacokinetic
analysis. Patients will be treated with two formulations of genistein (a 43% genistein
preparation or a 90% preparation). This is a phase I study, and patients will be treated on
one of three dosing levels. Patients will be randomly assigned to receive one formulation
first, followed by a washout period, and will then receive the second preparation (i.e., a
randomized cross over design). Information from this study will be used to optimally design
a multiple dose study wherein patients will be treated for longer periods of time. The
duration of this study is estimated to be about 4 weeks long for each patient.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Federal Government
980099
NCT00001696
April 1998
March 2001
Name | Location |
---|---|
National Cancer Institute (NCI) | Bethesda, Maryland 20892 |