Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma

Exclusion Criteria

• •Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE version 4) Grade 2 (excluding cases of alopecia)
• •Patients with history of allergic or hypersensitivity reaction to study drug or placebo or their excipients
• •Current participation in another investigational trial
• •Patients with significant cardiovascular disease
• •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin
• •Congenital long corrected QT interval (QTc) syndrome, history of drug induced QTc prolongation, or QTc interval unmeasurable or more than 450 ms
• •Abnormal serum electrolytes such as potassium, magnesium and calcium
• •Uncontrolled hypertension, despite optimal management
• •Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization
• •Non-healing wound, ulcer, or bone fracture
• •Evidence or history of bleeding diathesis or coagulopathy disorder
• •Hemorrhage/bleeding event ≥ Grade 3
• •Thrombotic or embolic events including transient ischemic attacks within the past 6 months
• •Subjects with symptomatic brain metastases or Subjects with brain metastases under corticosteroid treatment
• •Pregnant or breast-feeding patients
• •Patients with uncontrolled infections
• •Known HIV infection or infection with hepatitis B or C
• •Immunosuppression
• •Subjects with seizure disorder requiring medication • Subjects undergoing renal dialysis
• •Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
• •Any malabsorption condition