A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/15/2012 |
| Start Date: | August 2012 |
| End Date: | October 2014 |
| Contact: | Astellas Pharma Global Development |
| Email: | clintrials.info@us.astellas.com |
| Phone: | 800-888-7704 |
A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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.
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
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