Clinical trial · Interventional
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR
NCT01396148CI-TRIAL-00037828completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib malate | Drug | Sunitinib | ALIAS |
| sunitinib malate dose escalation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Children with GIST
- description
- children ages 6yrs-\<18yrs
- interventionNames
- Drug: sunitinib malate dose escalation
- type
- EXPERIMENTAL
- label
- Young adults with GIST
- description
- young adults ages 18yrs-\<21 yrs
- interventionNames
- Drug: sunitinib malate
Primary outcomes (6)
- measure
- Estimated Steady-State Maximum Plasma Concentration (Cmax,ss) of Sunitinib and Its Metabolite
- timeFrame
- pre-dose on Day 1, Day 12-18 and Day 25-29 of Cycle 1,2, 3 and 2, 4, 6, 8 hours post-dose on Day 1 Cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of GIST. * Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country * Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable disease. Exclusion Criteria: * Current treatment with another investigational agent. * Prior sunitinib treatment. * Prior therapy with known risk for cardiovascular complications.
References
Publications (2)
- DERIVEDWang E, DuBois SG, Wetmore C, Verschuur AC, Khosravan R. Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):343-352. doi: 10.1007/s13318-021-00671-7. Epub 2021 Apr 14. PMID 33852135
- DERIVEDVerschuur AC, Bajciova V, Mascarenhas L, Khosravan R, Lin X, Ingrosso A, Janeway KA. Sunitinib in pediatric patients with advanced gastrointestinal stromal tumor: results from a phase I/II trial. Cancer Chemother Pharmacol. 2019 Jul;84(1):41-50. doi: 10.1007/s00280-019-03814-5. Epub 2019 Apr 20. PMID 31006038