A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
- Participants will be given a study medication-dosing calendar for each treatment cycle.
Each treatment cycle lasts four weeks during which time participants will take RAD001
and bicalutamide orally, once per day. RAD001 will be provided from the research
pharmacy at the hospital and a prescription will be given for bicalutamide to obtain
from a local pharmacy.
- A history, physical exam, and blood tests will be performed every four weeks. An
assessment of the tumor by Chest CT scan, chest x-ray, bone scan, and abdomen/pelvis CT
or MRI will be performed every 12 weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the best overall response and duration of response, taking into consideration measurable disease, bone metastases and PSA.
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|