Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer

Inclusion criteria

• Histologically confirmed as anaplastic thyroid cancer
• Unresectable disease
• Have measurable lesion defined by the RECIST version 1.1
• Have adequate organ function and meet following laboratory value:

• Bone marrow function test within 14 days prior to enrollment:

neutrophil count>=1.5 x 103/microL blood platelet count>=10.0 x 104/microL hemoglobin amount>=9.0 g/dL

• Liver function test within 14 days prior to enrollment:

AST,ALT<=3.0 x ULN(without liver metastatic) AST,ALT<=5.0 x ULN(with liver metastatic) bilirubin<=2.0 mg/dL

• Kidney function test within 14 days prior to enrollment:

GFR estimation>=50 ml/min/1.73 m2 GFR estimation calculated by following formula. Male:194 x(serum creatinine concentration)-1.094 x(Age)-0.287 Female:Male GFR estimation x 0.739

• Cardiac function test within 28 days prior to enrollment: 12-lead electrocardiogram: no clinically important abnormality as shown below: heart disease, severe arrhythmia etc.
• Regardless of usage of antihypertensive drug, systolic blood pressure <=140 mm Hg and diastolic blood pressure <=90 mm Hg (If already taking antihypertensive drug, must have capacity of further antihypertensive therapy.)
• ECOG performance status 0-2
• Ability to swallow oral medications
• Life expectancy greater than 8 weeks
• Have signed written informed consent to participate in this study

Exclusion criteria

• Have complications or medical history of

• Complication of brain metastasis (Exclude if cured and in clinically stable condition for more than 1 month prior to screening.)
• Treatment required complication of systemic infectious disease
• Complication of pulmonary fibrosis or interstitial pneumonitis
• Medical history of clinically significant cardiovascular disease within 6 months of initial dose as: NYHA class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment e) Uncontrollable complication of diabetes mellitus f) hemoptysis within 3 weeks of enrollment (blood volume of more than half of teaspoon) g) Medical history of hemorrhagic or thrombotic disease within 6 months of enrollment h) If proteinuria values above 2+ by urinary protein qualitative test, conduct 24-hour urine collection and the urine protein determined as 1g/24 hours or more. (can substitute to the ratio of proteinuria in morning urine/creatinine) i) Malabsorption at gastrointestinal tract and any of the complication diseases that investigator considers that will be affected to lenvatinib absorption j) Recent major surgery within 2 weeks (if needle biopsy within 1 week) of enrollment k) Drainage required celomic fluid stagnation
• Have history of lenvatinib administration
• Confirmed tumor invasion to the carotid arteries
• Have history of high dose external radiation therapy to cervical region, and irradiated tumor location close to the carotid arteries.
• Have any unresolved toxicity greater than 1 by CTCAE v4.0.
• Have active double cancer
• Female patients who are pregnant, lactating, breast feeding or have childbearing potential
• Psychiatric disorder and regarded by the investigator as inadequate for this study enrollment
• Confirmed as no resistance to any component of this drug
• Currently receiving other interventional clinical study treatment