Ponatinib for Squamous Cell Lung and Head and Neck Cancers
Status:
Terminated
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that the drug is being studied. It also means that the FDA has not
yet approved ponatinib for use in patients, including people with your type of cancer.
In order to participate on this study, it must first be determined whether or not a patient's
lung or head and neck squamous cell cancer (SCC) has an alteration in FGFR kinase is made
from an experimental test on your squamous cell cancer tissue sample. This experimental test
is a "genetic test" or "genotyping test", which is a method used to study a tumor's genes.
The results are for research purposes only and are not considered "genetic testing" for the
purpose of diagnosing medical conditions. Cancers develop as a result of changes that occur
in human genetic material (DNA); these changes are called mutations or alterations. This
experimental test gives no information about any of the genes in the normal cells of the
patient's body, but it helps identify abnormal genes (like FGFR kinase mutations or
alterations) usually found only in cancer cells. We will use this experimental test to
determine whether or not a tumor contains a required alteration/mutation and thus may respond
to ponatinib.
Ponatinib is an investigational, oral anti-cancer drug designed to inhibit abnormal proteins
found in cancer cells and may cause those cancer cells to die. In laboratory testing,
ponatinib has been shown to inhibit a family of proteins called FGFR kinases, and this
genetic alteration/mutation has been found in some squamous cell lung cancers. There is
laboratory evidence that alterations/mutations in FGFR kinases in squamous cell lung cancers
may be driving the growth of these tumors and that inhibiting these FGFR kinases with
ponatinib may decrease or stop the growth of lung SCC.
In this research study, we are looking to see if the study drug, ponatinib, can keep cancer
from growing.