AURKA and head and neck squamous cell carcinoma: As single-agent, the safety and activity of alisertib has been evaluated in a Phase II study in advanced refractory or relapsed tumors, including non-small cell lung cancer (NSCLC), small lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), breast cancer, and gastro-esophageal adenocarcinoma, all exhibiting high levels of AURKA.