A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.
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ClinicalTrials.gov Identifier: NCT01227746
Verified January 2014 by National University Hospital, Singapore. Recruitment status was: Recruiting
Imatinib is the current standard treatment for advanced GIST. Previous studies have shown that GIST genotype was associated with treatment outcomes with exon 11 having superior outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response rate was higher at when imatinib was given at 800mg daily compared with the standard dose of 400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response in metastatic GISTs is intriguing, more information is needed before mutation testing is adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate, overall survival does not appear to be better with high-dose therapy. The investigators propose to conduct a retrospective analysis of mutational analysis on patients with GIST and determine the relationship between patient response and imatinib dose.
Condition or disease
Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Asian patients with advanced gastro-intestinal stromal tumors (GIST) treated with imatinib.
Histologic diagnosis of advanced stage or metastatic GIST
Asian patient (as defined by the investigator)
First line treatment with imatinib
Availability of tumor samples for kit mutation analysis
Availability of tumor response rate and or time to progression data