A phase I/II study of sunitinib in young patients with advanced gastrointestinal stromal tumor
Abstract
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: Gastrointestinal Stromal Tumors.
Primary outcome: Estimated Steady-State Maximum Plasma Concentration (Cmax,ss) of Sunitinib and Its Metabolite; Estimated Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose AUC(0-24) of Sunitinib and Its Metabolite; Estimated Oral Clearance (CL/F) of Sunitinib and Its Metabolite; Maximum Observed Plasma Concentration (Cmax) of Sunitinib and Its Metabolite; Time to Reach Maximum Observed Plasma Concentration (Tmax) for Sunitinib and Its Metabolite; Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose AUC(0-8) for Sunitinib and Its Metabolite.
Enrollment: 6 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 6 participants or records.
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