Participants
diarrhoea, alopecia, Cancer
ADVERSE EVENT, SOLID TUMOUR, BRAIN METASTASES, DISEASE, MINOR, CENTRAL NERVOUS SYSTEM DISEASE, ADVERSE EVENT, ONCOLOGY, ALOPECIA, CANCER
The study enrolled patients aged ≥18 years, with histological or cytological confirmation of a solid tumour. They could have received ≤3 prior chemotherapy regimens in the metastatic setting. Other key inclusion criteria included Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1, measurable or non-measurable (but evaluable in non-target lesions) disease according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST1.1), adequate organ function, and predicted life expectancy ≥12 weeks.Patients must not have received radiotherapy, immunotherapy, chemotherapy or investigational drugs within 21 days or 5 half-lives (with a minimum of 21 days) of enrolment (screening), and could have no unresolved National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 treatment-related adverse event (TRAE) of grade >1, with the exception of alopecia. Radiotherapy or surgery for brain metastases was allowed if therapy was completed ≥3 weeks previously, neurologic symptoms were mild, and there was no evidence of central nervous system disease progression or requirement for chronic corticosteroid therapy. Other key exclusion criteria included previous treatment with alisertib, grade ≥2 diarrhoea, major surgery ≤21 days or minor surgery ≤7 days from starting study drug, and pregnancy, lactation, or breastfeeding.