A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.

• Conditions: Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib
• Interventions: Procedure: Tumor biopsies

• Registration Number: NCT01227746
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Study Start: 2011-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Histologic diagnosis of advanced stage or metastatic GIST
2. Asian patient (as defined by the investigator)
3. First line treatment with imatinib
4. Availability of tumor samples for kit mutation analysis
5. Availability of tumor response rate and or time to progression data

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumor biopsies	Tumor biopsies	-

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore