An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor Vemurafenib in Patients With Metastatic or Unresectable Papillary Thyroid Cancer (PTC) Positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine

Inclusion Criteria:

- Adult patients. >/= 18 years of age

- Histologically confirmed metastatic or unresectable papillary thyroid cancer for
which standard curative or palliative measures do not exist or are no longer
effective; patients whose tumors exhibit areas of "other histology" may be enrolled,
provided the tumor histology remains predominantly papillary

- Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test)

- Radioactive Iodine resistant disease

- Prior therapy excluding (Cohort 1) or including (Cohort 2) tyrosine kinase inhibitor
(TKI)

- Clinically relevant disease progression according to RECIST criteria within the
prior 14 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematological, renal and liver function

Exclusion Criteria:

- Histological diagnosis other than papillary thyroid carcinoma (PTC), including
squamous cell variants of PTC or PTC with areas of squamous metaplasia

- Active or untreated CNS metastases

- History of or known carcinomatous meningitis

- Anticipated or ongoing administration of any anti-cancer therapies other than those
administered in the study

- Active squamous cell skin cancer that has not been excised or adequately healed post
excision

- Previous treatment with any agent that specifically and selectively targets the MEK
or BRAF pathway

- Prior radiotherapy to the only measurable lesion

- Clinically relevant cardio-vascular disease or event within the prior 6 months