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

• Status: Completed
• Trial end date: 2018-02-26
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.; Pfizer
• Collaborators: Astellas Pharma Inc; Medivation is now a wholly owned subsidiary of Pfizer Inc.; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Treatments: Docetaxel

Criteria

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