Status:
COMPLETED
Ponatinib in Advanced NSCLC w/ RET Translocations
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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" m...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- History of arterial thrombotic events (myocardial infarction, stroke or peripheral vascular disease).
- Uncontrolled hypertension
- Taking medications that are known to be associated with Torsades de Pointes
- Ongoing active infection
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01813734
Start Date
September 1 2013
End Date
August 1 2018
Last Update
December 24 2019
Active Locations (5)
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1
University of California, Irvine
Orange, California, United States, 92868
2
University of Maryland
Baltimore, Maryland, United States
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
4
Karmanos Cancer Institute
Detroit, Michigan, United States