A Study of Alisertib (MLN8237) in Adult East Asian Participants With Advanced Solid Tumors or Lymphomas

Exclusion Criteria

• •Female participants who are lactating or pregnant
• •Treatment with any investigational products, systemic antineoplastic treatment, or antineoplastic treatment with glucocorticoids within 21 days preceding the first dose of alisertib
• •Treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment within 42 days (21 days if clear evidence of progressive disease)
• •Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors or H2-receptor antagonists
• •Treatment with radioimmunoconjugates such as ibritumomab tiuxetan or tositumomab within 56 days preceding first alisertib dose
• •Major surgery within the 14 days preceding the first dose of alisertib
• •Life-threatening or uncontrolled medical illness unrelated to cancer
• •Known gastrointestinal (GI) disease or procedures that could interfere with the oral absorption or tolerance of alisertib
• •Inability to swallow capsules
• •Inadequate bone marrow or other organ function
• •Diagnosed or treated for another malignancy within 2 years of first dose of alisertib, or previously diagnosed with another malignancy and have any radiographic or biochemical marker evidence of active disease. In the case of prior prostate cancer treated with radiotherapy, the prostate specific antigen (PSA) may be detectable, but must be \< 1 ng/mL. Participants with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy of any type are not excluded
• •Other severe acute or chronic medical or psychiatric conditions, including uncontrolled diabetes, or laboratory abnormality
• •Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection