Study of the Effect of Esomeprazole or Rifampin on the Pharmacokinetics of Alisertib and Evaluation of the Effect of Alisertib on the QTc Interval in Patients With Advanced Solid Tumors or Lymphomas
Inclusion Criteria:
- Male or female patients 18 years or older
- Histologically or cytologically confirmed metastatic and/or advanced solid tumors or
lymphomas
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival longer than 3 months from enrollment in the study
- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or agree to abstain from heterosexual intercourse
- Male patients who agree to practice effective barrier contraception or agree to
abstain from heterosexual intercourse
Exclusion Criteria:
- Treatment with any anticancer therapy or any investigational agents within 4 weeks
before the first dose of alisertib
- Known hypersensitivity or intolerance to rifampin (for patients considered for
the rifampin DDI group) or to esomeprazole (for patients considered for the
esomeprazole DDI group)
- Recurrent nausea and/or vomiting within 14 days before the first dose of alisertib,
and known GI abnormality or GI procedure that could interfere with or modify the oral
absorption or tolerance of alisertib
- Patients requiring treatment with clinically significant enzyme inducers within 14
days before the first dose of alisertib and/or requiring the use of these medications
during the study
- A medical condition requiring use of pancreatic enzymes; or daily, chronic, or
regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists
- Patients requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose
anticoagulation to maintain patency of venous access devices).
- Any cardiovascular condition
- Female patients who are lactating or have a positive serum pregnancy test
- Major surgery within the 14 days preceding the first dose of alisertib
- Life-threatening or uncontrolled medical illness unrelated to cancer
- Newly diagnosed or uncontrolled cancer-related central nervous system (CNS) disease
- Autologous stem cell transplant within 3 months
- Prior allogeneic bone marrow or other organ transplantation
- Other severe acute or chronic medical or psychiatric condition
- Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface
antigen-positive status, or known or suspected active hepatitis C infection
Please note there are additional inclusion and exclusion criteria. The study center will
determine if you meet all of the criteria.