Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas
Condition: Advanced Solid Tumors; Lymphoma
MeSH terms: Lymphoma
Intervention: Alisertib
Intervention description: Alisertib ECT
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MLN8237; Alisertib; Food effects

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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