A Phase 1 Dose Escalation and Pharmacokinetic Study of Alisertib (MLN8237), an Aurora A Kinase Inhibitor, in Adult East Asian Patients With Advanced Solid Tumors or Lymphomas
Inclusion Criteria:
- Male or female East Asian patients 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 patients 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 patients 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 patients 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. Patients 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