A Phase 1b, Open-label, Safety and Tolerability Study of Oral MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and tolerability of MDV3100 in combination with Docetaxel
The primary criteria for the evaluation of safety and tolerability are: The percentage of patients who require dose reduction of docetaxel and/or MDV3100 following Treatment Periods 1 and 2; The percentage of patients who discontinue docetaxel or MDV3100 due to an adverse event.
United States: Food and Drug Administration
|Albany, New York 12208|
|McLean, Virginia 22101|