A Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma (KOSMIC)
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|ClinicalTrials.gov Identifier: NCT02623127|
Recruitment Status : Completed
First Posted : December 7, 2015
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thymic Carcinoma||Drug: Sunitinib||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Non-comparative, Open Label, Multi-center Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||October 2018|
Sunitinib will be administered orally at a dose of 50 mg once daily in 3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment.
- Objective response rate [ Time Frame: Up to 6 months ]CR or PR by RECIST criteria version 1.1
- Disease control rate [ Time Frame: Up to 6 months ]CR or PR or SD by RECIST criteria version 1.1
- 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] [ Time Frame: Up to 6 months ]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.
- Biomarker endpoint [ Time Frame: Day 1 ]When available, banked tumor tissue for genomic analysis for predictive biomarker of sunitinib.
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): NCT02623127
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Korea, Republic of, 463-707|
|Principal Investigator:||Jong Seok Lee, MD, PhD||Seoul National University Bundang Hospital|