This study aims to investigate the clinical activity of sunitinib in patients with advanced thymic carcinoma who have failed chemotherapy.
Sunitinib (Sutent®; Pfizer, New York, NY, USA) is a multitargeted tyrosine-kinase inhibitor (TKI) with activity against the stem cell-factor receptor (KIT) and platelet-derived growth-factor receptor (PDGFR), vascular endothelial growth-factor receptor (VEGFR), glial cell line-derived neurotrophic factor receptor (rearranged during transfection \[RET\]), colony-stimulating factor-1 receptor (CSF1R), and Fms-like tyrosine kinase-3 receptor (FLT3). Sunitinib is a potent inhibitor of mutant KIT with additional inhibitory effects on VEGF receptors that potentially might make it more effective than imatinib against TCs. In the current version of NCCN guideline, sunitinib is suggested as one of the potential targeted therapeutics for advanced TCs. We planned this study to investigate the clinical efficacy and tolerability of sunitinib in patients with advanced or recurrent TCs in Korean population. In addition, we will collect tumor samples and blood samples from patients for the further exploration of predictive biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Seoul National University Bundang Hospital
Seongnam, South Korea
Objective response rate
CR or PR by RECIST criteria version 1.1
Time frame: Up to 6 months
Disease control rate
CR or PR or SD by RECIST criteria version 1.1
Time frame: Up to 6 months
Progression-Free Survival
Time frame: Up to 6 months
Overall survival
Time frame: From first day of study treatment to day of any kind of death, assessed up to 24 months
Incidence of treatment related adverse events [Safety and Tolerability]
Number of patients with adverse events during cycle 1 (each cycle is 21 days). Subjects will be evaluated for toxicity according to NCI-CTCAE(Common Terminology Criteria for Adverse Events) of version 4.0.
Time frame: Up to 6 months
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