Status:
COMPLETED
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01483014
Start Date
June 1 2008
End Date
January 1 2012
Last Update
November 18 2016
Active Locations (11)
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1
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30380-490
2
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130
3
Novartis Investigative Site
Florianópolis, Santa Catarina, Brazil, 88034-000
4
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01401-901