Participants and study design
tumours
TUMOURS, METASTATIC COLORECTAL CANCER, DISEASE PROGRESSION, METASTATIC DISEASE
Eligible patients with histologically confirmed non-resectable metastatic RAS wild-type metastatic colorectal cancer, and WHO performance status 0–1 were recruited onto this study. Patients were chemotherapy naive for metastatic disease and had RECIST measurable tumours. Prior adjuvant chemotherapy was allowed provided it was completed at least 6 months before trial entry. Patients received oral AZD8931 on days 1–4 in a 2-weekly schedule plus FOLFIRI starting on day 1, given every 2 weeks. Patients remained on treatment until disease progression, unless there were intolerable side-effects, treatment delays longer than 3 weeks or withdrawal of consent. If AZD8931 was stopped patients were permitted to continue to receive FOLFIRI alone.PANTHER adopted a seamless Phase I/II trial design. Phase I design was done using a dose-escalation continual reassessment method (CRM) [