A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Collaborator: Medivation, Inc.

Criteria

Inclusion Criteria:

• Progressive prostate cancer while on androgen deprivation therapy

• Castrate testosterone level

• Maintenance of surgical or medical castration for duration of study

• Radiographically visible metastatic disease

• Symptomatic from prostate cancer

• Eastern Cooperative Oncology Group (ECOG) 0-2

• Life expectancy >=6 months

Exclusion Criteria:

• Brain metastases or leptomeningeal disease

• Prior cytotoxic chemotherapy for prostate cancer

• Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor

• History of seizure or condition that may predispose to seizure

• History of loss of consciousness or transient ischemic attack within 12 months

• Clinically significant cardiovascular disease