Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer

Exclusion Criteria

• •Major surgery within 4 weeks before randomization.
• •Prior chemotherapy within the last 4 weeks prior to randomization.
• •RAI131 therapy within 3 months in patients with radioiodine uptake.
• •Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy).
• •Serum bilirubin \>1.5\*the upper limit of reference range (ULRR).
• •Creatinine clearance \< 30 ml/min (calculated by Cockcroft-Gault formula).
• •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5\*ULRR, or greater than 5.0\*ULRR if judged by the investigator to be related to liver metastases.
• •Clinically significant cardiovascular event (eg myocardial infarction), superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart failure \>II within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
• •History of arrhythmia (multifocal premature ventricular contractions \[PVCs\], bigeminy, trigeminy, ventricular tachycardia or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3), , or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted.
• •Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.