Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy

• Status: Completed
• Trial end date: 2017-11-02
• Target enrollment: 0
• Participant gender: Male

Summary

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Progressive prostate cancer

• Medical or surgical castration with testosterone less than 50 ng/dl

• One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Adequate bone marrow, hepatic, and renal function

• Able to swallow the study drug and comply with study requirements

• Informed consent

Exclusion Criteria:

• Metastases in the brain or active epidural disease

• Another malignancy within the previous 5 years

• Clinically significant cardiovascular disease

• Gastrointestinal disorder affecting absorption