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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| imatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib mesylate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response using the RECIST criteria | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 16 weeks | |
| Time and duration of response | 16 weeks | |
| Time to treatment failure |
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Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | 30380-490 | Brazil | ||
| Novartis Investigative Site |
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| 16 weeks |
| Overall survival | 16 weeks |
| Rio de Janeiro |
| Rio de Janeiro |
| 20230-130 |
| Brazil |
| Novartis Investigative Site | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01401-901 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01509-900 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05403-000 | Brazil |
| Novartis Investivative site | Belo Horizonte | Brazil |
| Novartis Investivative site | Florianópolis | Brazil |
| Novartis Investivative site | Porto Alegre | Brazil |
| Novartis Investivative site | Rio de Janeiro | Brazil |
| Novartis Investivative site | São Paulo | Brazil |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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