Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Inclusion Criteria:

   - Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular
   and Hurthle cell)

   - Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are
   eligible provided that the histology has no medullary differentiation nor anaplastic
   features

   - Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors]
   should be used as a basis for the assessment of disease progression)

   - RAI (radioactive iodine) refractory

Exclusion Criteria:

   - Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic
   and medullary carcinoma, lymphoma or sarcoma)

   - Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies
   (licensed or investigational) that target VEGF (vascular endothelial growth factor) or
   VEGF Receptors or other targeted agents

   - Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose
   chemotherapy for radiosensitization is allowed) or Thalidomide or any of its
   derivatives