A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment

Exclusion Criteria

• •Known or suspected neuroendocrine/small cell feature.
• •Use of any antineoplastic treatment post-chemotherapy, including but not limited to aminoglutethimide, ketoconozole, abiraterone acetate, Rad-223, sipuleucel-T, or enzalutamide. Continuing steroids is permitted.
• •Palliative radiation therapy within 2 weeks of Day 1, or within 4 weeks of Day 1 if a radionuclide was utilized.
• •Use of an investigational agent within 4 weeks of Day 1 visit.
• •Major surgery within 4 weeks prior to Day 1 visit.
• •History of seizure or any condition that may predispose to seizures (e.g., prior cortical stroke or significant brain trauma) at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening.
• •History of clinically significant cardiovascular disease including:
• •* Myocardial infarction or uncontrolled angina within 3 months;
• •* History of congestive heart failure New York Heart Association (NYHA) class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;
• •* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
• •* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
• •Clinically significant cardiovascular disease at screening including:
• •* Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mm Hg) at screening;
• •* Bradycardia as indicated by a heart rate of \< 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination;
• •* Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 105 mmHg at the screening visit.
• •Subject has a known or suspected hypersensitivity to enzalutamide or any components of the formulation used.
• •Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
• •Known or suspected brain metastasis or leptomeningeal disease.
• •Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months).
• •Absolute neutrophil count \< 1,500/μL, platelet count \< 75,000/μL, or hemoglobin \< 5.6 mmol/L (9 g/dL) at screening.
• •Total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times upper limit of normal (ULN) at screening.
• •Creatinine \> 177 μmol/L (\> 2 mg/dL) at screening.
• •Albumin \< 30 g/L (3.0 g/dL) at screening.
• •Treatment with abiraterone acetate prior to enzalutamide for metastatic castration - resistant prostate cancer (mCRPC) in the prechemotherapy setting. (Note: Patients who have received concomitant enzalutamide and abiraterone acetate therapies are not excluded).