A Phase II Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non-Metastatic Recurrent Prostate Cancer
This study is a phase II trial of NDGA in patients with hormone-sensitive non-metastatic
prostate cancer with a pharmacokinetics component. The first six patients enrolled will be
treated with a single 750 mg dose of oral NDGA on day -7 with measurement of pharmacokinetic
parameters over eight hours after the dose, then begin treatment with 2000 mg of oral NDGA
daily. Every four weeks, measurement of pharmacokinetic parameters at steady state will be
done for all patients. All patients will continue dosing with NDGA and will be followed for
PSA response and for safety. Measurement of pharmacokinetics for a 750 mg dose has been
chosen to evaluate levels with the dosage that patients will be taking at one time point
during the day (this is roughly one-third of the daily dose, which is administered in three
divided doses).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA Response
Monthly
No
United States: Food and Drug Administration
075511
NCT00678015
May 2008
June 2011
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |