Description:
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.
A Study of <span class="go-doc-concept go-doc-intervention">Sunitinib</span> In Young Patients With Advanced Gastrointestinal Stromal Tumor
Title
Brief Title: A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Official Title: A Phase I/ii Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Clinical Trial IDs
NCT ID: NCT01396148
ORG ID: A6181196
NCI ID: 2011-002008-33
Trial Conditions
Gastrointestinal Stromal Tumors
Trial Interventions
Drug |
Synonyms |
Arms |
sunitinib malate dose escalation |
|
Children with GIST |
sunitinib malate |
|
Young adults with GIST |
Trial Purpose
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.
Detailed Description
Trial Arms
Name |
Type |
Description |
Interventions |
Children with GIST |
Experimental |
children ages 6yrs-<18yrs |
sunitinib malate dose escalation |
Young adults with GIST |
Experimental |
young adults ages 18yrs-<21 yrs |
sunitinib malate |
Eligibility Criteria
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.
Minimum Eligible Age: 6 Years
Maximum Eligible Age: 20 Years
Eligible Gender: Both
Primary Outcome Measures
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
Secondary Outcome Measures
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 tumors) is observed
Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected safety endpoint (eg, absolute neutrophil count) is observed
Trial Keywords
Children and young adults with GIST
sunitinib malate
pharmacokinetics
tumor response
overall survival
tumor KIT mutation status