Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

Inclusion Criteria

Inclusion criteria:

1. Patients must have histologically or cytologically confirmed diagnosis of Medullary
Thyroid Cancer (MTC) or Differentiated Thyroid Cancer (DTC).

2. Measurable disease meeting the following criterion:

1. At least one lesion (≥ 1.5 cm in longest diameter for non-lymph nodes and ≥2.0
cm in longest diameter for lymph nodes) which is serially and accurately
measurable according to Modified Response Evaluation Criteria in Solid Tumors
(RECIST) using either computed tomography (CT) or magnetic resonance imaging
(MRI)

2. Lesions that have had electron beam radiotherapy must show evidence of
progressive disease based on Modified Response Evaluation Criteria in Solid
Tumors (RECIST) to be deemed a target lesion

3. Patients must show evidence of disease progression by Response Evaluation Criteria in
Solid Tumors (RECIST) using site assessment of computed tomography/magnetic resonance
imaging (CT/MRI) scans within 12 months (+1 month to allow for variances in patient
scanning intervals) prior to study entry.

4. Patients with Differentiated Thyroid Cancer (DTC) must be 131-I refractory/resistant:
never demonstrated 131-I uptake, progression despite 131-I uptake, or cumulative dose
of 131-I of > 600 mCi (last dose given at least 6 months prior to study entry).

5. Well controlled blood pressure prior to study entry.

6. Signed informed consent.

Exclusion criteria:

1. Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid,
metastases to the thyroid.

2. Brain or leptomeningeal metastases.

3. Significant cardiovascular impairment (history of congestive heart failure > New York
Heart Association [NYHA] Class II, unstable angina or myocardial infarction within 6
months of study start, or serious cardiac arrhythmia).

4. Marked baseline prolongation of QT/QTc interval.

5. Proteinuria > 1+ or > 30 mg in dipstick testing.

6. Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to
study entry.