Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
- Registration Number
- NCT01483014
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description imatinib imatinib mesylate -
- Primary Outcome Measures
Name Time Method Objective response using the RECIST criteria 16 weeks
- Secondary Outcome Measures
Name Time Method Time and duration of response 16 weeks Overall survival 16 weeks Time to treatment failure 16 weeks Progression free survival 16 weeks
Trial Locations
- Locations (2)
Novartis Investigative Site
🇧🇷São Paulo, SP, Brazil
Novartis Investivative site
🇧🇷Sao Paulo, Brazil