Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer

Exclusion Criteria

• •Symptomatic central nervous system (CNS) metastasis, or active CNS metastasis requiring medication.
• •WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period and for 4 months after the last dose of investigational product.
• •Women who are pregnant or breastfeeding.
• •Sexually active fertile men not using effective birth control for the entire study period and for 4 months after the last dose of investigational product if their partners are WOCBP.
• •Subjects who have uncontrolled intercurrent illness including, but not limited to, infection requiring systemic therapy, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled angina pectoris, uncontrolled peptic ulcer, cardiac arrhythmia requiring medication.
• •Subjects who are HIV antibody positive, HBs antigen positive, and/or HCV antibody positive.
• •Subjects with body cavity fluid retention which requires drainage.
• •Subjects with any major surgery within 8 weeks prior to study enrollment.
• •Subjects with major unhealed wounds or fracture.
• •Subjects with a history or concurrent diagnosis of gastrointestinal perforation.
• •Subjects with evidence of bleeding tendency or coagulopathy.
• •Subjects with a history of thromboembolism.
• •Subjects with a history of or concurrent pancreatitis.
• •Exposure to any investigational drug within 30 days of enrollment.
• •Subjects receiving radiation therapy or treatment with radionuclides within 6 to 2 weeks before first dose of XL184.
• •NSCLC expansion cohorts: subjects must not be diagnosed with another malignancy within 2 years before first dose of XL184.