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
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Lung Extensive Stage Small Cell Lung Cancer Limited Stage Small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Recurrent Small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer||Drug: Ponatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||171 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ponatinib in Cohorts of Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers|
|Actual Study Start Date :||September 24, 2013|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||November 2017|
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.
Ponatinib 45mg taken by mouth each day at the same time with or without food
- Biomarker FGFR1 (ISH/SISH) Score (Part A) [ Time Frame: Baseline ]Biomarker prevalence and its 95% (exact) confidence interval (CI) among the screening patients and for different histologies will be reported. Molecular cohorts for ISH and SISH positivity: FGFR1 ISH+/SISH+, FGFR1 ISH+/SISH-, FGFR1 ISH-/SISH+, and FGFR1 ISH-/SISH-
- Overlapping Frequency of FGFR1 (ISH/SISH) Biomarkers (Part A) [ Time Frame: Baseline ]Overlapping frequency and its 95% CI between biomarkers among the screening patients and for different histologies will also be reported.
- Objective Response Rate (ORR) Per RECIST v1.1 (Part B) [ Time Frame: From date of first dose until date of Disease Progression or death (up to 153 days), whichever occurred first ]Evaluated using Fisher's exact test with a descriptive p-value. Summarized using binomial proportions with 95% exact binomial confidence intervals.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935336
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Ross D Camidge, MD, PhD||University of Colorado, Denver|