The purpose of the first part of this study is to find the highest dose of three drugs — LGX818, cetuximab, and BYL719 — that can be given safely in patients with metastatic colorectal cancer that contains a mutation in the BRAF gene. The second part of the study will assess the effectiveness of two different drug combination in these patients: LGX818 and cetuximab, or LGX818/cetuximab/BYL719.
LGX818 is an investigational drug that blocks the activity of an abnormal form of the BRAF protein, which promotes the growth of come cancers. BYL719, another investigational drug, is an inhibitor of PI3 kinase, an enzyme which fuels the growth of several types of cancer. Cetuximab is an approved drug already used to treat metastatic colorectal cancer. It works by blocking the epidermal growth factor receptor, a protein which sends signals to cancer cells to tell them to grow and multiply. Laboratory research suggests that combining the drugs in this study may be more effective against advanced colorectal cancer than using them individually.
Patients in this study will be randomly assigned to one of two groups:
- LGX818 and cetuximab, or
- LGX818, cetuximab, and BYL719
LGX818 and BYL719 are taken orally (by mouth), while cetuximab is given intravenously (by vein).