Clinical trial NCT01045421 (phase 1/phase 2, status: completed)
Conditions: advanced nonhematological malignancies, non-small cell lung cancer, small cell lung cancer, metastatic breast cancer, head and neck squamous cell carcinoma, gastroesophageal adenocarcinoma
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: mln8237 (alisertib)
SMILES: COC1=CC(NC2=NC=C3CN=C(C4=C(C=CC(Cl)=C4)C3=N2)C2=C(F)C=CC=C2OC)=CC=C1C(O)=O
Eligibility criteria:

        Inclusion Criteria:

        Each patient 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 tumor
             (Phase 1 only)

          -  Phase 2 requires Non-small cell lung cancer (NSCLC); Small-cell lung cancer; Breast
             adenocarcinoma (female patients only); Squamous cell cancer of the head and neck
             (HNSCC); or Gastroesophageal adenocarcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Female patients who are post menopausal, surgically sterile, or agree to practice 2
             effective methods of contraception or abstain from heterosexual intercourse

          -  Male patients who agree to practice effective barrier contraception or agree to
             abstain from heterosexual intercourse

          -  Voluntary written consent

          -  Wiling to comply with scheduled visits, treatment plan, laboratory tests and other
             trial procedures

          -  Measurable disease (Phase 2 only)

        Exclusion Criteria:

        Patients meeting any of the following exclusion criteria are not to be enrolled in the
        study:

          -  Female patients who are pregnant or lactating

          -  Serious medical or psychiatric illness that could interfere with protocol completion

          -  Receipt of more than 2 previous cytotoxic chemotherapeutic regimens (4 previous
             regimens for breast cancer). There is no limit on the number of prior noncytotoxic
             therapies

          -  Prior treatment with Aurora A-targeted agents, including MLN8237

          -  Prior treatment with high-dose chemotherapy

          -  Prior allogeneic bone marrow or other organ transplant

          -  Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to
             first dose of MLN8237

          -  Symptomatic brain metastasis

          -  Radiotherapy to greater than 25% of bone marrow

          -  Diagnosis or treatment of another malignancy within 2 years preceding first dose of
             study drug except nonmelanoma skin cancer or in situ malignancy completely resected

          -  Myocardial infarction within 6 months of enrollment

          -  Uncontrolled cardiovascular condition

          -  Major surgery within 14 days of first dose of MLN8237

          -  Active infection requiring systemic therapy, or other serious infection

          -  Inability to swallow oral medication

          -  Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
             hepatitis C

          -  Patients requiring full systemic anticoagulation

          -  History of uncontrolled sleep apnea syndrome

          -  Treatment with clinically significant enzyme inducers within 14 days prior to the
             first dose of MLN8237 and during the study