Non Small Cell Lung Cancer Clinical Trial
Official title:
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
NCT number | NCT01813734 |
Other study ID # | 13-103 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | August 2018 |
Verified date | December 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | August 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland | Baltimore | Maryland |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Ohio State University | Columbus | Ohio |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | University of California, Irvine | Orange | California |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate | The number of participants that achieved either a partial or complete response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
From the start of treatment until disease progression or death, up to approximately 2 years | |
Secondary | Disease Control Rate | The number of participants that achieved either a partial or complete response or stable disease, assessed using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
From the start of treatment until disease progression or death, up to approximately 2 years | |
Secondary | Median Progression-Free Survival | The duration of time from study entry until disease progression (assessed using RECIST 1.1.) or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression. |
From study entry until disease progression or death, median duration of 3.8 months | |
Secondary | 1 Year Overall Survival Rate | The number of participants surviving one year after study entry | 1 year | |
Secondary | Number of Participants With Adverse Events | The number of participants with grade 3 plus adverse events as assessed using Common Toxicology Criteria for Adverse Events (CTCAE 4) that were deemed to be possibly, probably, or definitely related to study treatment. | From the start of treatment until 30 days after the end of treatment (up to approximately 2 years) |
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