A Multi-center, Single Arm, Phase II Study of Adjuvant Imatinib (Glivec®) in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor ( GIST)
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumors
Both
Gastrointestinal Stromal Tumors
Trial Information
A Multi-center, Single Arm, Phase II Study of Adjuvant Imatinib (Glivec®) in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor ( GIST)
Inclusion Criteria:
- 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 Criteria:
- Patient has received prior therapy with imatinib, or any other molecular targeted or
biological therapy.
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Recurrence Free Survival Rate
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSTI571BIC08
NCT ID:
NCT01172548
Start Date:
August 2008
Completion Date:
January 2014
Related Keywords:
- Gastrointestinal Stromal Tumors
- Resected GIST
- primary GIST
- tumor recurrence
- KIT receptor
- KIT positive
- advanced GIST
- minimal toxicity
- GIST
- Gastrointestinal Stromal Tumors
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