At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 60 enrolled
Drug / intervention
Sunitinib Malate (SU011248)drug
Likely dose
Sunitinib Malate (SU011248) 50 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 Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate
In Brief
A Phase 4 clinical trial evaluating Sunitinib Malate (SU011248) for Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors. Completed, enrolled 60 participants across 4 sites.
Detailed Summary
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionApr 2014
Study CompletionOct 2014
TodayJul 2026
First PostedNov 19, 2008
Enrollment StartNov 1, 2008
Primary CompletionApr 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 17.6 years ago
Interventions
Sunitinib Malate (SU011248)drug
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.