Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Solid Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 multip...
Detailed Description
The drug tested in this study is called alisertib. Alisertib is being tested to assess the effect of a proton pump inhibitor and strong metabolic inducer on the PK of a single 50 mg dose of alisertib ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2016
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01844583
Start Date
June 25 2013
End Date
September 6 2016
Last Update
March 25 2019
Active Locations (7)
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1
Sarasota, Florida, United States
2
St Louis, Missouri, United States
3
Oklahoma City, Oklahoma, United States
4
Nashville, Tennessee, United States