Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Phase 2
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Gastrointestinal Stromal Tumors
Both
Gastrointestinal Stromal Tumors
Trial Information
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Inclusion Criteria:
- patients with age between 18 and 80 years
- diagnosis of GIST not previously treated
- Patients will be included in the protocol regardless of operability; in the case of
an operable tumor, patients are eligible if, in the opinion of the surgeon, resection
would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection
or other which cold compromise severely the quality of life or other GI function)
Exclusion criteria:
- presence of metastatic disease
- use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)
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: Treatment
Outcome Measure:
Objective response using the RECIST criteria
Outcome Time Frame:
16 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSTI571BBR10
NCT ID:
NCT01483014
Start Date:
June 2008
Completion Date:
January 2012
Related Keywords:
- Gastrointestinal Stromal Tumors
- Gastrointestinal,
- stromal,
- neoadjuvant,
- imatinib,
- mesylate,
- pre-operatory
- Gastrointestinal Stromal Tumors
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