drugset / Trial / NCT00237185

A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

NCT00237185 ↗

Phase 2 Completed 148 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.

Timeline

Start
2000-06
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg —
Subject Imatinib Small molecule 600 mg —