Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction

Exclusion Criteria

• •Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate inhibitors of CYP3A, or clinically significant CYP3A inducers or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study drug
• •Use of any nicotine-containing products within 14 days before the first dose of study drug
• •Central Nervous System Involvement or Symptomatic brain metastasis. Patients with brain metastases: must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy; and must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs
• •Female patients who are lactating or breastfeeding or have a positive serum pregnancy test
• •Serious medical or psychiatric illness that could interfere with participation in the study
• •Treatment with any investigational products or radiotherapy within 21 days before the first dose of study drug
• •Systemic anticancer therapy within 14 days before the first dose of study drug
• •Exposure to nitrosoureas or mitomycin C within 6 weeks before the first dose of study drug
• •Treatment with therapeutic monoclonal antibodies or antibody-drug conjugates within 60 days before the first dose of study drug
• •Radiotherapy or major surgery within the 14 days preceding the first dose of study drug
• •Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug
• •Life-threatening illness unrelated to cancer
• •Severe CNS, pulmonary, or renal disease not related to the patient's cancer
• •Known human immunodeficiency virus (HIV) positive
• •Evidence of uncontrolled cardiovascular conditions
• •QTc \> 500 milliseconds (msec) on a 12-lead ECG obtained during the Screening period
• •Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of IXAZOMIB
• •Known allergy to the study medication, its analogues, or excipients in the formulation