A Phase I Study of BYL719 Given with Cetuximab and Radiation Therapy in Patients with Stage III/IVB Head and Neck Cancer

Full Title

A Phase Ib Study of Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

Purpose

Cetuximab is a drug used to treat head and neck cancer. It works by blocking a protein called the epidermal growth factor receptor, preventing cancer cells from receiving the message to grow and multiply. It may be given in combination with radiation therapy. In this study, researchers want to find the highest dose of BYL719 that can be given safely with cetuximab and radiation therapy in patients with locally advanced head and neck cancer.

BYL719 is an investigational drug that inhibits PI3 kinase, an enzyme which fuels the growth of several types of cancer. It is taken orally (by mouth). 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 locally advanced (stage III/IVB) head and neck cancer.
  • Patients should be planning to have radiation therapy, and may not have previously had radiation to the head and neck area.
  • At least 4 weeks must pass between any major surgery and the completion of any other therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to see if you are eligible for this study, please contact Dr. David Pfister at 646-888-4232.

Protocol

14-116

Phase

I

Investigator