Phase 2
N=9
Ponatinib in Advanced NSCLC w/ RET Translocations
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01813734 ↗Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Dec 2019
Primary outcome: Primary: Overall Response Rate — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ponatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
— | — |
| SECONDARY Disease Control Rate |
5 | — |
| SECONDARY Median Progression-Free Survival |
3.8 | — |
| SECONDARY 1 Year Overall Survival Rate |
5 | — |
| SECONDARY Number of Participants With Adverse Events |
2 | — |
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 has been found that some people with NSCLC have a change (mutation) in a certain gene called the RET gene. This mutated gene may help cancer cells grow. Only participants with a RET mutation will be allowed to participate. In this study, investigators are testing the strategy of using a study drug designed to inhibit or shut off growth signals that results from the mutated RET gene.
Ponatinib is an anti-cancer drug that has been used in research studies for other types of cancer. Ponatinib blocks several growth signals in cancer cells, including RET. In this research study, investigators are looking to see whether ponatinib is effective and safe in treating NSCLC harboring RET rearrangements.
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT01813734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.