Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy

Exclusion Criteria

• •1. Any anti-cancer treatment (except BSC) within 21 days prior to the first dose of study drug
• •2. Major surgery (any surgical procedure that involves anesthesia or respiratory assistance) within 21 days prior to the first dose of study drug or scheduled surgery during the study (except for bile duct drainage)
• •3. Ascites of moderate, severe, or requiring drainage
• •4. Proteinuria of ≥ 2+ on dipstick testing (Grade ≤ 1 confirmed by quantitative assessment is eligible)
• •5. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug
• •6. New York Heart Association congestive heart failure of class II or above, unstable angina, myocardial infarction, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months from the first dose of study drug
• •7. A prolonged QT/QTc interval (QTcF \> 480 ms)
• •8. Known to be human immunodeficiency virus (HIV) positive
• •9. Active infection requiring systemic treatment
• •10. Bleeding or thrombotic disorders or chronic systemic use of anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents (treatment with low molecular weight heparin is permitted)
• •11. Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 21 days prior to the first dose of study drug
• •12. Active malignancy (except for BTC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the cervix, or early stage gastric/colorectal cancer) within the past 24 months prior to the first dose of study drug
• •13. Diagnosed with meningeal carcinomatosis
• •15. Known intolerance to the study drug or any of the excipients
• •16. History of drug or alcohol dependency or abuse within the last 24 months prior to the first dose of study drug
• •17. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study
• •18. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive human chorionic gonadotropin \[hCG or B-hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 3 days before the first dose of study drug.
• •19. For either males unless undergoing a successful vasectomy (confirmed azoospermia) or females of childbearing potential, the participant and his/her partner do not agree to use a medically appropriate method of contraception throughout the entire study period
• •* the use of condom, contraceptive sponge, contraceptive foam, contraceptive jelly, diaphragm, or intrauterine device, otherwise using oral contraceptive (percutaneous or transvaginal also allowed) for at least 28 days before the first dose of study drug