drugset / Trial / NCT00135005

Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

NCT00135005

Phase 1 Completed 59 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

Timeline

Start
2005-08
Primary completion
2006-11
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule
Subject Nilotinib Small molecule