drugset / Trial / NCT00171977

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

NCT00171977

Phase 4 Completed 64 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2004-07
Primary completion
2009-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg