Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib
Condition: Advanced Solid Tumors; Lymphoma
MeSH terms: Lymphoma
Intervention: [^14C]-alisertib; alisertib
Intervention description: [^14C]-alisertib oral solution; Alisertib enteric coated tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total
      radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in
      plasma and urine, and of TRA in plasma and whole blood.
    

Eligibility criteria:

        Inclusion Criteria:

        Each participants must meet all of the following inclusion criteria to be enrolled in the
        study:

          -  18 years or older.

          -  Histologically or cytologically confirmed metastatic and/or advanced solid 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.

          -  Expected survival longer than 3 months from enrollment in the study.

          -  Radiographically or clinically evaluable tumor.

          -  Suitable venous access for the conduct of blood sampling.

          -  Recovered from the reversible effects of prior antineoplastic treatment (with the
             exception of alopecia and Grade 1 neuropathy).

          -  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.

          -  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
             abstain from heterosexual intercourse.

        Exclusion Criteria:

        Participants meeting any of the following exclusion criteria are not to be enrolled in the
        study:

          -  Female participants who are lactating or have a positive serum pregnancy test.

          -  Treatment with any investigational products or systemic antineoplastic treatment
             within 21 days before the first dose of alisertib.

          -  Medical conditions requiring daily, chronic, or regular use of proton pump
             inhibitors(PPIs) within 7 days preceding the first dose of alisertib, or H2-receptor
             antagonists within 24 hours preceding the first dose of alisertib.

          -  Participants requiring systemic anticoagulation (excluding low-dose aspirin, or
             low-dose anticoagulation to maintain patency of venous access devices). Low molecular
             weight heparin, administered as preventive treatment, is allowed if the participant
             has tolerated treatment with a stable dose and schedule without bleeding complications
             for more than 1 month.

          -  Major surgery within the 14 days preceding the first dose of alisertib.

          -  Infection requiring systemic intravenous (IV) antibiotic therapy within 14 days
             preceding the first dose of study drug, or other severe infection.

          -  Life-threatening or uncontrolled medical illness unrelated to cancer.

          -  Ongoing nausea or vomiting that is Grade 2 or worse in intensity.

          -  Diarrhea that is Grade 2 or worse in intensity or use of an antimotility agent to
             control diarrhea to an intensity of Grade 1 or lower level.

          -  Known GI disease or GI procedures that could interfere with the oral absorption,
             excretion, or tolerance of alisertib.

          -  History of urinary and/or fecal incontinence.

          -  History of uncontrolled sleep apnea syndrome and other conditions that could result in
             excessive daytime sleepiness such as severe chronic obstructive pulmonary disease.

          -  Inability to swallow tablets, or inability or unwillingness to avoid taking anything
             by mouth except for water and prescribed medications for 2 hours before and 1 hour
             after the first dose of alisertib.

          -  Inadequate bone marrow or other organ function as specified in study protocol.

          -  Any cardiovascular condition specified in the study protocol.

          -  Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface
             antigen-positive status, or known or suspected active hepatitis C infection.

          -  Inability to comply with study visits and procedures including required inpatient
             confinement (approximately 11-17 days).

        Please note that there are additional exclusion criteria. The study center will determine
        if you meet all of the criteria.