A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to 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 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