Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
|ClinicalTrials.gov Identifier: NCT01935336|
Recruitment Status : Active, not recruiting
First Posted : September 5, 2013
Last Update Posted : November 6, 2018
|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)|
|Estimated Enrollment :||110 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 :||May 21, 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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
- Prevalence of each biomarker (Part A) [ Time Frame: Up to 5 years ]Biomarker prevalence and its 95% (exact) confidence interval (CI) among the screening patients and for different histologies will be reported.
- Overlapping frequency of biomarkers (Part A) [ Time Frame: Up to 5 years ]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: Up to 5 years ]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: Up to 5 years ]The number of adverse events and percentages will be tabulated per organ and per visit.
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|