Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2

Exclusion Criteria

• •Be pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test result within 7 days of enrollment into the study. Male and female subjects of childbearing potential (including women who have been amenorrheic for less than 1 year) must use appropriate birth control during the entire duration of the study, or the subject must be surgically sterile.
• •Have symptomatic brain metastasis
• •Have received any other anti-cancer treatment or investigational drug/treatment within 28 days prior to study Day 1.
• •Have a history of another malignancy within the last 5 years.
• •Have inadequate organ function.
• •Have heart failure defined by an ejection fraction of less than or equal to 50% as measured by MUGA.
• •Have Class II, III or IV symptoms of heart failure as defined by the New York Heart Association, or uncontrolled arrhythmias, or recent history of myocardial infarction or angina pectoris.
• •Have a medical condition that may interfere with intake and/or absorption of the study drug (e.g., gastrectomy or resection of major portion of small intestine).
• •Have any other serious disease or condition present at screening or at study Day 1 that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.