Ponatinib for Squamous Cell Lung and Head and Neck Cancers

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Treatments: Ponatinib

Criteria

Inclusion Criteria:

• Measurable disease

• Documented evidence of disease progression following most recent therapy

• Estimated life expectancy greater than 12 weeks

Exclusion Criteria:

• Pregnant or breastfeeding

• Prior chemotherapy or brain radiotherapy within 4 weeks of entering study

• Receiving other investigational agents

• Untreated or progressive brain metastases

• Prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to ponatinib

• Known HIV positive on combination antiretroviral therapy

• Clinically uncontrolled hypertension

• Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence for at least 5 years

• Active or uncontrolled clinically significant infection

• Chronic GI disease that may affect bioavailability of ponatinib

• History of significant bleeding disorder unrelated to cancer

• Uncontrolled intercurrent illness

• Clinically significant ventricular arrythmia

• History of chronic pancreatitis, alcohol abuse or uncontrolled hypertriglyceridemia