Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

A PHASE 1B, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF ORAL MDV3100 IN COMBINATION WITH DOCETAXEL IN MEN WITH ADVANCED PROSTATE CANCER

The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.

Inclusion Criteria:

• Willing and able to provide informed consent;
• Men, 18 years of age or older;
• Histologically or cytologically confirmed adenocarcinoma of the prostate;
• Ongoing androgen deprivation therapy

Exclusion Criteria:

• Severe concurrent disease;
• Known or suspected brain metastasis;
• History of another malignancy within the previous 5 years;
• Prior treatment with docetaxel-based chemotherapy