Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men With Prostate Cancer: a Randomized,Double-blind,Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
In phase I the investigators are evaluating the safety of the product and checking blood
levels of the active components. In phase II the investigators are evaluating the effect of
MPX on PSA doubling time
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
(Phase I) Maximum Tolerated Dose
To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy
Approximately 7 months to reach MTD
Yes
Michael A Carducci, MD
Principal Investigator
Johns Hopkins University
United States: Johns Hopkins University Safety Monitoring Committee
J1161
NCT01317199
July 2011
June 2014
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Sibley Memorial Hospital | Washington, District of Columbia 20016 |
Howard University College of Medicine | Washington, District of Columbia 20059 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Johns Hopkins Hospital | Baltimore, Maryland 21287 |