Phase 2 Study of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Exclusion Criteria

• •1. Any prior therapy for second-line treatment of SCLC.
• •2. Participants who relapsed ≥ 180 days after their response to first-line treatment.
• •3. Prior treatment with an Aurora A specific-targeted or pan-Aurora-targeted agent, including alisertib, or any other investigational agent.
• •4. Prior treatment with paclitaxel or any other taxane agent.
• •5. Known hypersensitivity to Cremophor® EL, paclitaxel, or its components.
• •6. Any comorbid condition or unresolved toxicity that would preclude administration of alisertib or weekly paclitaxel.
• •7. Prior history of ≥ Grade 2 neurotoxicity that is not resolved to ≤ Grade 1.
• •8. Participants with symptomatic and/or progressive brain metastases or with carcinomatous meningitis.
• •9. Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of alisertib and during study conduct. Major prohibited enzyme inducers include: phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine, and St. John's wort.
• •10. Inability to swallow alisertib or other orally administered medications.
• •11. Requirement for administration of proton pump inhibitor (PPI), H2 antagonist, or pancreatic enzymes.
• •12. Diagnosed with or treated for another malignancy within 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease.
• •13. Other severe acute or chronic medical or psychiatric condition(s) per protocol.
• •14. History of myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, any ongoing cardiac arrhythmias of Grade \> 2, thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug.
• •15. Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C.
• •16. Surgery within 3 weeks (or 2 weeks for a minor surgery) before study enrollment and not fully recovered to baseline or to a stable clinical status.
• •17. Participants who are pregnant, lactating, or do not agree to use effective methods of contraception during the study treatment period through 6 months after the last dose of study drug per protocol.