At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
imatinib mesylatedrug
Likely dose
imatinib mesylate 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.
A Phase II, Non-Randomized, Open-Label Multicenter Study of 5 Year Adjuvant Imatinib Mesylate (Gleevec®) in Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST)
In Brief
A Phase 2 clinical trial evaluating imatinib mesylate for Gastrointestinal Stromal Tumor (GIST). Completed, enrolled 91 participants across 21 sites.
Detailed Summary
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumor (GIST)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartJul 2009
Primary CompletionDec 2016
TodayJul 2026
First PostedMar 23, 2009
Enrollment StartJul 22, 2009
Primary CompletionDec 20, 2016
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 17.3 years ago
Interventions
imatinib mesylatedrug
imatinib mesylate was supplied in 100 and 400 mg tablets