Overview

Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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 newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Imatinib Mesylate
Criteria
Inclusion Criteria:

- underwent macroscopically curative resection;

- immunohistochemically confirmed KIT (CD117)-positive tumors;

- judged as being high-risk according to the criteria for risk classification

Exclusion Criteria:

- 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.