At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 6 enrolled
Drug / intervention
sunitinib malate dose escalation +1 moredrug
Likely dose
sunitinib malate dose escalation 15mgfrom 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 I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR
In Brief
A Phase 2 clinical trial evaluating sunitinib malate dose escalation and sunitinib malate for Gastrointestinal Stromal Tumors. Completed, enrolled 6 participants across 9 sites in 3 countries.
Detailed Summary
Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumors
CountriesCzechia, France, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartJun 2012
Primary CompletionAug 2017
TodayJul 2026
First PostedJul 18, 2011
Enrollment StartJun 1, 2012
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 15.0 years ago
Interventions
sunitinib malate dose escalationdrug
sunitinib starting dose will be 15mg/m\^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).
sunitinib malatedrug
sunitinib 50mg daily on Schedule 4/2