A Study of Alisertib (MLN8237) in Adult East Asian Participants With Advanced Solid Tumors or Lymphomas
Condition: Advanced Solid Tumors; Lymphomas
MeSH terms: Lymphoma
Intervention: Alisertib
Intervention description: Alisertib enteric-coated tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: East Asian Patients; Advanced solid tumors; Lymphomas; MLN8237; Alisertib; Aurora A Kinase Inhibitor; Drug therapy

Summary:

      The purpose of this study was to determine the safety profile, maximum tolerated dose (MTD),
      recommended Phase 2 dose (RP2D), and to characterize the pharmacokinetic (PK) profile of
      alisertib twice daily (BID) dosing for 7 days in East Asian participants with advanced solid
      tumors or lymphomas. The secondary objective was to describe any antitumor activity that may
      have been observed with alisertib treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female East Asian participants 18 years or older

          -  Histologically or cytologically confirmed metastatic and/or advanced solid tumors or
             lymphomas for which no effective standard treatment is available

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Expected survival longer than 3 months from study enrollment

          -  Radiographically or clinically evaluable tumor

          -  Female participants who are post menopausal for at least 1 year, surgically sterile,
             or agree to practice 2 effective methods of contraception through 30 days after the
             last dose of study drug or agree to abstain from heterosexual intercourse

          -  Male participants who agree to practice effective barrier contraception through 6
             months after the last dose of alisertib or agree to abstain from heterosexual
             intercourse

          -  Voluntary written consent

        Exclusion Criteria:

          -  Female participants who are lactating or pregnant

          -  Treatment with any investigational products, systemic antineoplastic treatment, or
             antineoplastic treatment with glucocorticoids within 21 days preceding the first dose
             of alisertib

          -  Treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other
             unconjugated antibody treatment within 42 days (21 days if clear evidence of
             progressive disease)

          -  Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors
             or H2-receptor antagonists

          -  Treatment with radioimmunoconjugates such as ibritumomab tiuxetan or tositumomab
             within 56 days preceding first alisertib dose

          -  Major surgery within the 14 days preceding the first dose of alisertib

          -  Life-threatening or uncontrolled medical illness unrelated to cancer

          -  Known gastrointestinal (GI) disease or procedures that could interfere with the oral
             absorption or tolerance of alisertib

          -  Inability to swallow capsules

          -  Inadequate bone marrow or other organ function

          -  Diagnosed or treated for another malignancy within 2 years of first dose of alisertib,
             or previously diagnosed with another malignancy and have any radiographic or
             biochemical marker evidence of active disease. In the case of prior prostate cancer
             treated with radiotherapy, the prostate specific antigen (PSA) may be detectable, but
             must be < 1 ng/mL. Participants with completely resected basal cell carcinoma,
             squamous cell carcinoma of the skin, or in situ malignancy of any type are not
             excluded

          -  Other severe acute or chronic medical or psychiatric conditions, including
             uncontrolled diabetes, or laboratory abnormality

          -  Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface
             antigen-positive status, or known or suspected active hepatitis C infection