A Phase Ib/II Study of LGX818 and Cetuximab with or without BYL719 in Patients with BRAF-Mutant Metastatic Colorectal Cancer

Protocol
14-019
Full Title
A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients with BRAF Mutant Metastatic Colorectal Cancer
Phase
I/II
Purpose

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).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic colorectal cancer that contains a mutation in the BRAF gene. The mutated protein produced by this gene is the target of LGX818.
  • Patients’ cancers must have continued to grow despite at least one regimen of chemotherapy.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Rona Yaeger at 646-888-4179.

Disease(s)
Colorectal Cancer
Locations
Related Diseases