Status:
COMPLETED
Safety and Efficacy Evaluation of Two Year Imatinib Treatment in Adjuvant Gastrointestinal Stromal Tumor (GIST)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
GISTs are the most common mesenchymal tumors of the gastrointestinal tract. Approximately 95% of GISTs are positive for KIT (CD117)-the receptor for stem cell factor (SCF). GISTs are not responsive to...
Eligibility Criteria
Inclusion
- Histologically proven diagnosis of primary GIST (without peritoneal or distant metastasis) with positive immunostaining for KIT (CD117);
- Undergone complete gross resection of a primary GIST within 70 days prior to enrollment (includes R0 \[negative microscopic margins\] and R1 \[positive microscopic margins\]);
- Intermediate or high risk of recurrence based on Corless criteria (Section 5.1):
Exclusion
- Patient has received prior therapy with imatinib, or any other molecular targeted or biological therapy.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01172548
Start Date
August 1 2008
End Date
March 1 2014
Last Update
May 31 2017
Active Locations (29)
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1
Novartis Investigative Site
Algiers, Algeria, 016000
2
Novartis Investigative Site
Al Mansurah, Egypt
3
Novartis Investigative Site
Cairo, Egypt
4
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380009