A Phase II, Open-Label Study of Ponatinib, A Multi-Targeted Oral Tyrosine Kinase Inhibitor, in Advanced Non-Small Cell Lung Cancer Harboring RET Translocations
Participants in this research study will be asked to undergo some screening tests or
procedures to confirm that eligibility. 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 participants do not
take part in the research study. These tests and procedures include the following: medical
history, vital signs, physical exam, performance status, electrocardiogram, echocardiogram,
routine blood tests, pregnancy test and an assessment of tumor by CT or MRI. If these tests
show that a participant is eligible to participate in the research study, he/she will begin
the study treatment. If a patient does not meet the eligibility criteria, he/she will not be
able to participate in this research study.
Participants will take the study drug once a day, every day of the cycle. Each treatment
cycle lasts 28 days (4 weeks). Participants will be given a drug diary to record the drug
they take each day. The diary will also include special instructions for taking the study
drug.
For cycles 1-20, participants will visit the clinic to have tests and procedures done at the
time points listed here: On Day 1-physical exam, vital signs, performance status,
electrocardiogram, routine blood tests, pharmacokinetic test, clinical exam and assessment
of tumor. On day 15 of cycle 1-vital signs, routine blood tests and clinical exam.
For cycles 11 and on, participants will visit the clinic every 6 weeks. Some of these visits
will happen on Day 1 of the cycle and some of these visits will happen on Day 15 of the
cycle. At each visit, the following tests and procedures will be done: physical exam, vital
signs, performance status, electrocardiogram, routine blood tests, clinical exam, and an
assessment of your tumor.
Participants will visit the clinic when their study doctor takes them off study drug
permanently. They will also visit the clinic 30 days after stop taking the study drug. The
following tests and procedures will be done: physical exam, vital signs, performance status,
electrocardiogram, routine blood tests, pregnancy test, clinical exam and a tumor
assessment.
Investigators would also like to keep track of participant's medical condition for two years
after their first study dose. Investigators will contact participants by telephone every 3
months. If participants still come to the clinic, visits might be used as contact.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
To evaluate the overall response rate (ORR) of ponatinib in RET-positive NSCLC as assessed by RECIST criteria
2 years
No
United States: Food and Drug Administration
13-103
NCT01813734
June 2013
Name | Location |
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Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |