At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 644 enrolled
Drug / intervention
Nilotinib (AMN107) +1 moredrug
Likely dose
Not stated in 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.
A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
In Brief
A Phase 3 clinical trial evaluating Nilotinib (AMN107) and imatinib (STI571) for Gastrointestinal Stromal Tumor (GIST). Completed, enrolled 644 participants across 165 sites in 35 countries.
Detailed Summary
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumor (GIST)
CountriesArgentina, Austria, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Egypt, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartMar 2009
Primary CompletionOct 2014
TodayJul 2026
First PostedNov 5, 2008
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 17.7 years ago
Interventions
Nilotinib (AMN107)drug
imatinib (STI571)drug