Status:
COMPLETED
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
20-74 years
Phase:
PHASE4
Brief Summary
This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newl...
Eligibility Criteria
Inclusion
- underwent macroscopically curative resection;
- immunohistochemically confirmed KIT (CD117)-positive tumors;
- judged as being high-risk according to the criteria for risk classification
Exclusion
- synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
- received therapy with Imatinib Mesylate prior to study entry;
- cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)
- Other protocol-defined inclusion / exclusion criteria may apply.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00171977
Start Date
July 1 2004
Last Update
August 7 2012
Active Locations (1)
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1
Novartis Investigative Site
Tokyo, Japan