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A Pharmacokinetic Study of Genistein, a Tyrosine Kinase Inhibitor

Phase 1
Not Enrolling

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Trial Information

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.

Inclusion Criteria

Must be 18 years old or greater.

ECOG performance status of 0-1.

Individuals without a history of cancer are eligible, as are those with a history of
cancer. Individuals with a history of cancer (excluding non-melanomatous skin cancer )
will need to submit their pathology slides for review in the Laboratory of Pathology, NCI.

Must be able to understand and give informed consent.

Life expectancy greater than 6 months.

Hgb greater than or equal to 8.0gm/dl, platelets greater than or equal to
100,000/microliters, ANC greater than or equal to 1000/microliters, creatinine less than
or equal to 2.0/mg/dl, SGPT and SGOT less than or equal to 147 and 168 U/L, total
bilirubin less than or equal to 2 mg/dl (patients with a higher level of bilirubin due to
a familial defect in bilirubin metabolism will be considered on an individual basis).

No history of breast cancer.

No pregnant or breast feeding subjects.

Must not be HIV positive.

No history of venous thrombosis within the past year.

No medical conditions, which, in the opinion of the investigators would jeopardize either
the patient or the integrity of the data obtained.

No patients who are currently receiving active therapy for neoplastic disorders. However,
patients with prostate cancer who are on an LHRH agonist (e.g., Lupron or Zoladex), or who
have undergone surgical castration, are eligible for study.

No patients who are on estrogen therapy.

No patients taking hormonal forms of contraception.

No patients with a known soy intolerance.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

March 2001

Related Keywords:

  • Cancer
  • Anti-metastatic
  • Chemoprevention
  • Isoflavinoid
  • Prostate Cancer
  • Signal Transduction



National Cancer Institute (NCI) Bethesda, Maryland  20892