presence of active serious disease, active infection, or comorbidity that may prevent study enrollment (at the discretion of the clinical investigator)
known or suspected brain metastases or active leptomeningeal dissemination
history of other malignant neoplasm except non‐melanoma skin carcinoma during the previous 5 years
absolute neutrophil count < 1500/µL, platelet < 100,000/µL, or hemoglobin < 5.6 mmol/L (< 9 g/dL) at screening visit (notably: patients must not receive any growth factor during the previous 7 days or any blood transfusion during the 28 days preceding the hematology sampling performed at screening)
total bilirubin, alanine aminotransferase, or aspartate aminotransferase > 2.5 x upper limit of normal at screening visit
creatinine > 177 µmol/L (> 2 mg/dL) at screening visit
albumin ≤ 30 g/L (≤ 3.0 g/dL) at screening visit
history of seizures or any other seizure‐predisposed pathology; history of loss of consciousness or transitory ischemic attack during the 12 months preceding the screening visit
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clinically significant cardiovascular disease including:
myocardial infarction (6 months preceding the screening)
uncontrolled angina (3 months preceding the screening)
congestive heart failure New York Heart Association (NYHA) class 3 or 4, congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition scan performed within 3 months results in a left ventricular ejection fraction ≥ 45%
history of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes)
history of Mobitz II second‐ or third‐degree heart block without a permanent pacemaker in place
hypotension as indicated by systolic blood pressure < 86 mmHg at the screening visit
bradycardia as indicated by a heart rate of < 50 beats per minute on the screening electrocardiogram
uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
gastrointestinal disorder affecting absorption (e.g. gastrectomy, active peptic ulcer disease within last 3 months)
major surgery within 4 weeks of enrollment (Day 1 visit)
radiation therapy for treatment of the primary tumor within 3 weeks of enrollment (Day 1 visit)
use of herbal products that may have hormonal anti‐prostate cancer activity and/or are known to decrease prostate‐specific antigen (PSA) levels (e.g. saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment (Day 1 visit)
any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
