CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 248 enrolled
Drug / intervention
Nilotinib +1 moredrug
Likely dose
Nilotinib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00471328
NCT00471328Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted May 9, 2007·Updated Jun 12, 2012

In Brief

A Phase 3 clinical trial evaluating Nilotinib and Best Supportive Care (BSC) +/- imatinib or sunitinib for Gastrointestinal Stromal Tumors. Completed, enrolled 248 participants across 35 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumors
CountriesAustralia, Austria, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2008
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.1 years ago

Interventions

Nilotinibdrug

Nilotinib 400 mg twice daily (bid)

Best Supportive Care (BSC) +/- imatinib or sunitinibother

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.