A Study of MLN8054 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •Pregnant or lactating
• •Major surgery within the 28 days preceding the first dose of study treatment
• •Serious infection within the 28 days before the first dose of study treatment
• •Life-threatening illness unrelated to cancer
• •Ongoing nausea or vomiting of any severity
• •\> Grade 1 diarrhea
• •Known GI disease that could interfere with the oral absorption or tolerance of MLN8054
• •Difficulty swallowing capsules
• •Inability to fast overnight before the morning dose of MLN8054 and to remain nothing by mouth (\[NPO\] except for water and prescribed medications) for 2 hours after each dose of MLN8054
• •Received more than 4 previous cytotoxic chemotherapeutic regimens, including regimens used as adjuvant or neo-adjuvant therapies. There is no limit on the number of noncytotoxic therapies (eg, hormonal and immunologic) that patients may have received. Tyrosine kinase inhibitors (eg, Tarceva and Iressa) are considered noncytotoxic compounds.
• •Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution
• •Prior treatment with radiation therapy involving \> 25% of the hematopoietically active bone marrow (see Table 15-1 for the distribution of active bone marrow in adults)
• •Clinical and/or radiographic evidence of cerebral metastases. However, patients who have a history of central nervous system (CNS) metastasis but who have no radiographic or clinical evidence of residual tumor (eg, following complete surgical resection) are not excluded from participation in this study.
• •Clinically significant abnormalities or arrhythmias on 12-lead electrocardiogram (ECG) in the opinion of the investigator
• •Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
• •Known or suspected disorder of bilirubin metabolism or excretion, including, but not limited to, Gilbert's syndrome, Crigler-Najjar syndrome, Dubin-Johnson syndrome, and Rotor syndrome
• •Inclusion in a trial of an investigational drug in the previous 4 weeks
• •Admission of alcohol abuse or an inability to restrict consumption of alcohol to no more than 1 standard unit of alcohol per day during the study and for 21 days from the last dose of study treatment.