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

Official Title

A Phase I/ii Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumour

Summary:

Children and young adults with gastrointestinal stromal tumours (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumour responses and overall survival will be assessed.

Trial Description

Primary Outcome:

• Pharmacokinetics- Estimated steady-state maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662
• Pharmacokinetics- estimated area under the plasma concentration versus time curve from time zero to 24 hours post dose (AUC24) for sunitinib and its active metabolite SU012662
• Pharmacokinetics- estimated oral clearance (CL/F) for sunitinib
• Pharmacokinetics- Observed single-dose maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662
• Pharmacokinetics- Observed time to Cmax (tmax) for sunitinib and its active metabolite SU012662
• Pharmacokinetics- Observed area under the plasma concentration versus time curve from time zero to 8 hours post dose (AUC8) for sunitinib and its active metabolite SU012662

• Objective response rate
• Duration of response
• Progression-free survival
• Overall survival at 2 years after study enrollment
• Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected efficacy parameter (eg, sum of largest diameters for target tumours) is observed
• Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected safety endpoint (eg, absolute neutrophil count) is observed

View this trial on ClinicalTrials.gov