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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

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.


Inclusion Criteria:



- Histologically or cytologically confirmed advanced NSCLC

- Molecular confirmation of a RET translocation

- At least one measurable lesion as defined by RECIST

- No restriction on number of prior therapies

- Estimated life expectancy of at least 12 weeks

- Able to swallow and retain orally administered medication

- Must agree to use an effective form of contraception from enrollment through 30 days
after the end of study treatment

- Willingness and ability to comply with scheduled visits and study procedures

Exclusion Criteria:

- Clinically significant gastrointestinal abnormalities

- Pregnant or breastfeeding

- Major surgery within 28 days of initiating therapy

- History of CNS disease (Note: Participants with brain metastases will be eligible if
treated appropriately and if they remain clinically stable).

- Anti-cancer therapy within 3 weeks

- History of significant bleeding disorder unrelated to cancer

- History of acute pancreatitis within 1 year of study entry or history of chronic
pancreatitis

- History of alcohol abuse

- Uncontrolled hypertriglyceridemia

- Significant uncontrolled or active cardiovascular disease

- Uncontrolled hypertension

- Taking medications that are known to be associated with Torsades de Pointes

- Ongoing active infection

- Known history of HIV

- Diagnosed with or received anti-cancer therapy for another primary malignancy within
3 years prior to entry (except for non-melanoma skin cancer or in situ cancers)

- Any condition or illness tha could compromise patient safety or interfere with the
evaluation of the drug

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate

Outcome Description:

To evaluate the overall response rate (ORR) of ponatinib in RET-positive NSCLC as assessed by RECIST criteria

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

13-103

NCT ID:

NCT01813734

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • RET gene mutation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617