Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
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ClinicalTrials.gov Identifier: NCT01935336 |
Recruitment Status :
Completed
First Posted : September 5, 2013
Results First Posted : February 11, 2022
Last Update Posted : February 11, 2022
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Sponsor:
University of Colorado, Denver
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
University of Colorado, Denver
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Tracking Information | ||||
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First Submitted Date ICMJE | August 27, 2013 | |||
First Posted Date ICMJE | September 5, 2013 | |||
Results First Submitted Date ICMJE | April 5, 2021 | |||
Results First Posted Date ICMJE | February 11, 2022 | |||
Last Update Posted Date | February 11, 2022 | |||
Actual Study Start Date ICMJE | September 24, 2013 | |||
Actual Primary Completion Date | January 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 [ Time Frame: From date of first dose until date of Disease Progression (up to 153 days). Assessed at Day 1, Day 8, Day 15 of each 28 day cycle) ] Adverse events will be tabulated per participant, per organ, and per visit.
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Original Secondary Outcome Measures ICMJE |
Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 [ Time Frame: Up to 5 years ] The number of adverse events and percentages will be tabulated per organ and per visit.
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers | |||
Official Title ICMJE | A Phase II Study of Ponatinib in Cohorts of Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers | |||
Brief Summary | This phase II trial studies how well ponatinib hydrochloride works in treating patients with stage III-IV lung cancer. Ponatinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. | |||
Detailed Description | This study will look at the safety and effectiveness of the investigational drug ponatinib in lung cancer. The investigators hope that ponatinib will work against tumors that have certain biomarkers. Therefore, the study will pre-screen patients for these certain biomarkers before enrolling them into the main treatment study. Different doses of ponatinib may be tested in this study. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Ponatinib
Ponatinib 45mg taken by mouth each day at the same time with or without food
Other Names:
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Study Arms ICMJE | Experimental: Ponatinib
Patients receive ponatinib hydrochloride taken by mouth once or twice a day. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: Ponatinib
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
171 | |||
Original Estimated Enrollment ICMJE |
110 | |||
Actual Study Completion Date ICMJE | November 2017 | |||
Actual Primary Completion Date | January 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01935336 | |||
Other Study ID Numbers ICMJE | 13-2002.cc NCI-2013-01644 ( Other Identifier: National Cancer Institute ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | University of Colorado, Denver | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University of Colorado, Denver | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Ariad Pharmaceuticals | |||
Investigators ICMJE |
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PRS Account | University of Colorado, Denver | |||
Verification Date | January 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |