A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a
straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4
weeks. FLT-PET scans are performed at screening and again at day 28, following initiation
of treatment in the first 10 patients. Patients are assessed for adverse events every two
weeks for the first month and monthly thereafter. Patients are assessed for response by PSA
every 4 weeks and when applicable, for objective response every 2 months. If 4 or more
responses are seen in the first 39 patients then the study will expand to 60 patients.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical Response Rate
Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
Patients were followed for a median of 315 days
No
Daniel J George, MD
Principal Investigator
Duke University Health System
United States: Food and Drug Administration
Pro00009495 (7521)
NCT00629525
August 2005
January 2010
Name | Location |
---|---|
Duke University Medical Center | Durham, North Carolina 27710 |