drugset
drugset / Trial / NCT00471328

Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

NCT00471328 ↗

Phase 3 Completed 248 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.

Timeline

Start
2007-03
Primary completion
2008-08
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule 400 mg —
Background Imatinib Small molecule — —
Background Sunitinib Small molecule — —

Indications

gastrointestinal stromal tumor