Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma

Exclusion Criteria

• •Diagnosis of primary CNS malignancy or carcinomatous meningitis.
• •Patient has symptomatic brain metastasis.
• •Prior bone allogeneic bone marrow or stem cell transplant.
• •Prior radiotherapy involving \> or equal to 30% of the hematopoietically active bone marrow, within 21 days before the start of the study drug.
• •Systemic antineoplastic therapy within 28 days before the start of the study drug, except for luteinizing hormone-releasing-hormone (LHRH) agonist therapy.
• •Exposure to nitrosureas or mitomycin C within 42 days before the start of the study drug.
• •Treatment with monoclonal antibodies within 28 days before the start of the study drug.
• •Known allergy or hypersensitivity to compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
• •Female patients who are lactating or who have a positive serum pregnancy test during the screening period or a positive serum pregnancy test during the screening period.
• •Myocardial infarction within 6 months before enrollment.
• •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• •Abnormalities on 12-lead electrocardiogram (ECG) as specified in the protocol.
• •Infection requiring systemic anti-infective therapy within 14 days before the start of study drug.
• •Known human immunodeficiency virus (HIV)positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
• •Diagnosed or treated for another malignancy within 2 years before the start of study drug or previously diagnosed with another malignancy and have any evidence of residual disease.
• •Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
• •Treatment with any investigational products within 28 days before the first dose of study drug.
• •Systemic use of strong CYP3A inhibitors or inducers (as specified in the protocol) within 14 days before the first dose of study drug.