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Sponsors and Collaborators: |
University of California, San Francisco Insmed |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00678015 |
This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA administration and assessing the proportion of patients who experience a 50% decline in PSA.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Nordihydroguaiaretic Acid (NDGA) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non-Metastatic Recurrent Prostate Cancer |
Estimated Enrollment: | 28 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Nordihydroguaiaretic Acid (NDGA)
NDGA 2000mg daily
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior definitive therapy for prostate cancer consisting of one of the following:
Prior adjuvant or neoadjuvant androgen deprivation is permitted, provided:
Exclusion Criteria:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Jay Trovato, RN 415-353-9268 jay.trovato@ucsfmedctr.org | |
Contact: Paula Dutton, BS 415-885-7871 walshp@medicine.ucsf.edu | |
Principal Investigator: Charles Ryan, MD |
Responsible Party: | University of California, San Francisco ( Charles Ryan, MD, Principal Investigator ) |
Study ID Numbers: | 075511 |
Study First Received: | May 12, 2008 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00678015 |
Health Authority: | United States: Food and Drug Administration |
NDGA Prostate Cancer |
Nordihydroguaiaretic Acid Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Recurrence |
Anti-Inflammatory Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Protective Agents Lipoxygenase Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |