Phase I Single and Multiple-Dose Safety and Pharmacokinetic Clinical Study of Genistein in Normal Volunteers and in Prostate Neoplasia (Multiple Dose Safety and Pharmacokinetic Clinical Study of Genistein in Prostate Neoplasia)
OBJECTIVES: I. Determine the safety and pharmacokinetics of genistein in patients with stage
II, III, or IV prostate cancer.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
randomized to one of two treatment arms. Arm I: Patients receive oral genistein twice daily.
Arm II: Patients receive oral placebo twice daily. Treatment continues for 3 months in the
absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 6 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Leslie Fischer, PhD, MPH, RD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|