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

Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo.
Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option
to unblind study treatment after progression and to receive open label sorafenib regardless
of initial treatment assignment. Following discontinuation of study treatment, subjects were
followed for survival every 3 months in long-term follow-up. Subjects who terminated study
treatment (either double only or double blind and open label) for reasons other than death,
lost to follow-up or consent withdrawn entered long-term follow up

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