Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer
The purpose of this study is to find out if dovitinib is an effective treatment for patients with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on anti-vascular endothelial growth factor (VEGF) treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall Response [ Time Frame: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ] [ Designated as safety issue: No ]Measured by an X-Ray and/or a CT and/or an MRI (RECIST criteria)
- Disease Control Rate [ Time Frame: Measured at 8 weeks ] [ Designated as safety issue: No ]The total proportion of patients who demonstrate a response to treatment. Measured by RECIST criteria.
- Progression Free Survival [ Time Frame: From start of treatment until the date of death from any cause, assessed up to 100 months ] [ Designated as safety issue: No ]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.
- Toxicity [ Time Frame: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment. ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
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
The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory initial observations of the relationship between FGF signaling alterations and the clinical activity of dovitinib. This trial is expected to provide key biologic information that will inform the clinical development of dovitinib and provide initial evaluation of the analytic characteristics of these potential predictive biomarkers of its efficacy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676714
|United States, California|
|University of California Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Thomas Semrad, MD||University of California, Davis|