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

Astellas

Status and phase: Withdrawn; Phase 2

Conditions: Metastatic Castration-Resistant Prostate Cancer

Treatments: Drug: Enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01663415

9785-UC-0001

Details and patient eligibility

About

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.

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Enzalutamide

Experimental group

Treatment:

Drug: Enzalutamide