A Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer: a Rational anti-CancerStem Cell Combination.

Objective

This is a research study of an investigational drug called IPI-926 used together with Cetuximab. The main goal of this research study is to test the safety and tolerability of the study drug in combination with cetuximab and to discover what side effects it has, whether good or bad, on you and your cancer. The study will determine the highest dose of the study drug that can be given to subjects without causing severe or life-threatening side effects. IPI-926 is an investigational drug. "Investigational" means that IPI-926 has not been approved by the U.S. Food and Drug Administration (FDA). The FDA is the U.S. government agency that reviews the results of research of potential new drugs and decides if a drug can be sold in the U.S. IPI-926 will be called "the study drug" throughout the rest of this consent form. Cetuximab is an FDA-approved chemotherapy drug for the treatment of head and neck cancer.

IRB Protocol Number

11-0109

Principal Investigator(s)

ANTONIO JIMENO

Cancer Trials

• Head and Neck Cancers

Sponsor(s)

NCI

Contact

SARAH MCFADDEN at 720-848-7272
or SARAH.MCFADDEN@UCDENVER.DU

Eligibility and Other Participant Information

What To Expect : A screening period will determine eligibility. The treatment period will last as long as you are responding to the study drug. The follow-up period will consist of phone calls and clinic visits. // Eligibility criteria include but are not limited to 18 years or older and tumor growth or spread during or following chemotherapy or other treatment. There is no standard therapy for your type of cancer.