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Trial intelligence / Profile preview
Neoadjuvant Imatinib in Locally Advanced GIST
NCT00112632Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2005
- Countries
- 2
- Sponsor
- Technical University of Munich
- Modality
- Small Molecules
- Drugs
- imatinib
- Conditions
- gastrointestinal stromal tumor (GIST)
01
Overview
Phase 2, open-label, single-arm trial of imatinib in gastrointestinal stromal tumor (GIST), sponsored by Technical University of Munich. Primary endpoints: Radiographic objective response rates, Histological response and 1 more. Started Feb 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Neoadjuvant Imatinib
Patients receive oral imatinib mesylate followed by surgery
03
Who it enrols
Adult patients with locally advanced, potentially resectable (but not R0) GIST expressing c-Kit or PDGFRA, with adequate organ function and no severe comorbidities.
04
Endpoints
Primary
Radiographic objective response rates
Histological response
Overall tumor response
Secondary
R0-resectability rate
Organ-preserving resectability rate
Time to progression of disease
Overall survival
Safety and tolerability
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