Non-Small Cell Lung Cancer, Head and Neck Cancer Clinical Trial
Official title:
Phase II Study of Ponatinib in Advanced Lung and Head and Neck Cancers With FGFR Kinase Alterations
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.
Patients will be asked to undergo some screening tests or procedures to find out if they can
be in the research study. Many of these tests and procedures are likely to be part of
regular cancer care and may be done even if it turns out that an individual does not take
part in the research study. If a patient has had some of these tests or procedures recently,
they may or may not have to be repeated. These screening tests include: medical history,
physical examination, vital signs, performance status, assessment of tumor(s), CT scan or
MRI scan of brain, routine blood tests, urine pregnancy test for women of childbearing
potential and electrocardiogram. Additionally at the time of screening patients will undergo
collection of an archival tumor tissue sample for tumor mutation testing.
If a patient takes part in this research study, he or she will be given a study drug-dosing
calendar for each treatment cycle. Each treatment cycle lasts 4 weeks during which time the
patient will be taking the study drug by mouth daily. The number of cycles the patient will
receive will depend on how the patient is tolerating the ponatinib and if your cancer has
worsened.
There is a possibility that the following tests or procedures may need to be done at times
other than those listed below. These may be done if the research doctors determine they are
medically necessary to monitor illness or any side effects a patient may be experiencing. It
is important that patients call their research doctor if at any time they are experiencing
side effects they cannot tolerate.
During all cycles patients will have a physical exam and be asked questions about their
general health and specific questions about any problems that they might be having and any
medications they might be taking.
If the patient's disease progresses while you are on this study, they will be given the
option of consenting to a new biopsy for research purposes at no financial cost to the
patient.
The investigators would like to keep track of your medical condition for the rest of each
patient's life. The investigators would like to do this by calling every six months to see
how the patients are doing. Keeping in touch with checking their condition helps the
investigators look at the long-term effects of the research study.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment