NCT01227746|Unknown
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Sponsor study identifier
observational
N/A
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2010
Actual (reported)October 25, 2010
Actual (reported)September 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Asian patients with advanced gastro-intestinal stromal tumors (GIST) treated with imatinib.
National University Hospital
Singapore, Singapore, Singapore
Tornillo L, Terracciano LM. An update on molecular genetics of gastrointestinal stromal tumours. J Clin Pathol. 2006 Jun;59(6):557-63. doi: 10.1136/jcp.2005.031112.
Heinrich MC, Corless CL, Duensing A, McGreevey L, Chen CJ, Joseph N, Singer S, Griffith DJ, Haley A, Town A, Demetri GD, Fletcher CD, Fletcher JA. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003 Jan 31;299(5607):708-10. doi: 10.1126/science.1079666. Epub 2003 Jan 9.
First Submitted
October 21, 2010
First Posted
October 25, 2010
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 22, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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