A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Pediatric Oncology, Pediatric Solid Tumors
NCT ID: NCT01396148 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-106


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.


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Katherine Janeway, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Histological diagnosis of GIST. - Patients with Stem Cell Factor Receptor gene (KIT)-mutant GIST must have demonstrated either disease progression or intolerance to imatinib mesylate. - 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.
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