Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib

• Status: Completed
• Trial end date: 2016-09-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Esomeprazole; Rifampin

Criteria

Inclusion Criteria:

• Male or female participants 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 participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse

• Male participants 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 participants considered for the rifampin drug-drug interaction [DDI] group) or to esomeprazole (for participants considered for the esomeprazole DDI group)

• Recurrent nausea and/or vomiting within 14 days before the first dose of alisertib, and known gastrointestinal (GI) abnormality or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib

• Participants 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

• Participants requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices).

• Any cardiovascular condition

• Female participants 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.