Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas
Completed · Phase 1
Conditions studied: Advanced Solid Tumors, Lymphoma
In brief
The purpose of this study is to evaluate the effect of food on the single-dose pharmacokinetics (PK) of alisertib administered as an enteric-coated tablet (ECT) formulation in participants with advanced solid tumors or lymphomas.
Key facts
- Study ID
- NCT01898078
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 26
- Starts
- 2013-07-16
- Expected to finish
- 2017-01-24
- Last updated by the study team
- 2019-06-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older
- Histologically or cytologically confirmed advanced tumors or lymphomas for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participant must meet protocol-specified laboratory values
- Suitable venous access
- Female participants who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time or agree to practice true abstinence
- Male participants who agree to practice effective barrier contraception during the entire study and through 4 months after the last dose of study drug OR agree to practice true abstinence
You may not qualify if…
- Prior or current investigational therapies within 4 weeks before the first dose of alisertib
- Female participants who are lactating or pregnant
- Participant requiring treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days before the first dose of alisertib and during the study
- Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors (PPIs) within 7 days preceding the first dose of alisertib, or histamine (H2)-receptor antagonists
- Participant requiring systemic anticoagulation
- Ongoing nausea or vomiting that is Grade 2 or worse in intensity
- Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib
- History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease
- Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- Participant who are lactose-intolerant or are unwilling/unable to consume the protocol specified standardized high-fat breakfast
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Study site — The Bronx, New York, United States
- Study site — Nashville, Tennessee, United States
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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