Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01676714|
Recruitment Status : Completed
First Posted : August 31, 2012
Results First Posted : May 15, 2017
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer Colorectal Cancer||Drug: Dovitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy|
|Study Start Date :||February 2013|
|Primary Completion Date :||January 2016|
|Study Completion Date :||June 2016|
500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
Other Name: TK1258
- Overall Response Rate [ Time Frame: Up to 100 months ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Disease Control Rate [ Time Frame: From start of treatment, up to 8 weeks ]The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.
- Progression Free Survival [ Time Frame: From start of treatment until the date of death from any cause, assessed up to 100 months ]The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Patients Who Experienced Treatment Related Toxicities [ Time Frame: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment. ]Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676714
|United States, California|
|University of California Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Thomas Semrad, MD||University of California, Davis|