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Phase II Study of Ponatinib in Advanced Squamous Cell Lung Cancers With FGFR Kinase Alterations

Phase 2/Phase 3
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

Phase II Study of Ponatinib in Advanced Squamous Cell Lung Cancers With FGFR Kinase Alterations

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

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate of patients with lung SCC treated with ponatinib

Outcome Description:

Investigate the response rate of patients with previously treated lung SCC to ponatinib as defined by the proportion of subjects with investigator-assessed confirmed complete response (CR) or partial response (PR)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Peter Hammerman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617