Study Design
This was a 2-part, open-label, multicenter study (NCT01927341) comprising a phase Ib dose escalation followed by a phase II clinical efficacy evaluation and safety assessment of the combination treatment binimetinib + panitumumab. For phase II, 4 patient populations were enrolled based on previous anti-EGFR monoclonal antibody (mAb) therapy and The study was conducted at 8 sites in the US, Belgium, Canada, France, Germany, Italy, Netherlands, and Spain. The study protocol was approved by the independent ethics committee or institutional review board at each site, and the study was conducted according to International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines concerning Good Clinical Practice. Written informed consent was obtained from all patients before screening.