NCT00471328

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

A Randomized, Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib Versus Best Supportive Care With or Without a Tyrosine Kinase Inhibitor (Investigator's Choice) in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Nilotinib	Nilotinib 400 mg twice daily (bid)
OTHER	Best Supportive Care (BSC) +/- imatinib or sunitinib	Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-08-01
• Completion: 2011-06-01
• First posted: 2007-05-09
• Last updated: 2012-06-12
• Results posted: 2011-05-17

Locations

35 sites across 13 countries: United States, Australia, Austria, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, Switzerland