Clinical Trial 23160

• Overview

  Study Title:

  A Phase 2 Study of Alisertib in Patients with Extensive Stage Small Cell Lung Cancer

  Objective:

  Primary * Determine whether any biomarker correlates with alisertib response Secondary * Determine investigator-assessed efficacy in the patient population * Determine survival outcomes in the patient population * Determine the safety profile of alisertib * Update the population pharmacokinetic (popPK) profile of alisertib

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  Alisertib (MLN8237); G-CSF ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Provide written, informed consent to participate in the study and follow the study procedures.
  • Aged at least18 years at signing of informed consent.
  • Pathologically confirmed SCLC.
  • Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy.
  • At least one measurable target lesion outside of the central nervous system (CNS) as defined by RECIST v1.1.
  • Must provide most recent formalin fixed paraffin embedded (FFPE) tissue biopsy. Archival tissue is acceptable; if archival tissue is unavailable, patient must be willing to provide fresh tissue biopsy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Negative serum pregnancy test for premenopausal women of childbearing potential (those who are biologically capable of having children) and for women less than 12 months after menopause.
  • Patients requiring full systemic anticoagulation must be on a stable dose and schedule.
  • Female patients of childbearing potential must agree and commit to the use of a highly effective method of contraception from the time of informed consent until 28 days after the last dose of the study treatment. If 1 of the highly effective methods cannot be used, using 2 other effective methods at the same time is required. Male patients must agree and commit to using a highly effective method of contraception while on treatment and for 3 months after last dose of study treatment. Male patients must refrain from donating sperm during the trial and for 3 months after last dose of study treatment.
  • Adequate major organ and hematologic function as defined by the screening parameters in the protocol.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Major surgery within 21 days of C1D1 (major according to the Investigators and/or Medical Monitors assessment).
  • Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
  • Grade 3 or higher dyspnea within 14 days of C1D1.
  • Any active infection requiring systemic treatment (antibacterial, antiviral, or antifungal) within 7 days of C1D1.
  • Immunocompromised patients, including: Known active Human Immunodeficiency Virus (HIV) infection as determined by HIV ribonucleic acid (RNA) viral load and CD4 count. Known active or uncontrolled hepatitis B or C infection as determined by positive hepatitis B tests (HBs and anti-HBc) or hepatitis C test (HCV antibody).
  • Known upcoming need for radiation therapy.
  • Active, uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure, unstable angina, myocardial infarction or ventricular arrhythmia within 12 months of C1D1.
  • Mean resting corrected QTcF interval >470 milliseconds or known history of congenital QT-prolongation or Torsade de Pointes.
  • Left ventricular ejection fraction (LVEF) > History of malignancy other than the one to be studied within the past 2 years with the exception of appropriately treated non-invasive malignancies (e.g., non-melanoma skin cancers, in situ carcinoma of the uterine cervix), unless the patient has been treated with curative intent with no evidence of disease for at least 2 years.
  • Unresolved Grade >1 toxicities from previous systemic anti-cancer therapy, defined as toxicities not yet improved to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v.5.0] Grade 0-1 or baseline, prior to C1D1, except for any Grade alopecia and Grade 2 neuropathy, Grade 2 fatigue, and residual toxicities from prior immunotherapy, including endocrinopathies adequately controlled by replacement therapy.
  • CNS metastases.
  • Currently pregnant or breast-feeding.
  • Significant chronic GI disorder that can impair the absorption of orally administered drugs (e.g., Crohns disease, malabsorption, or Grade 2 or more NCI CTCAE v.5.0 diarrhea of any etiology at baseline).
  • Any use of a proton pump inhibitor (PPI) and H2 receptor antagonists within 5 days prior to C1D1.
  • Treatment with moderate to strong CYP3A4 inducers (e.g., phenytoin, rifampin) and inhibitors (e.g., ketoconazole) within 14 days prior to C1D1 and during study conduct.
  • Known hypersensitivity to any component of the study treatment or compounds of similar chemical composition.
  • Any condition that, in the Investigators and/or Medical Monitors judgment, makes the patient an unreliable trial patient, unlikely to complete the trial, and/or unable to comply with the protocol procedures.
  • Unable or unwilling to swallow tablets.
  • Other exclusion criteria may apply.

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