The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.
This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 2 to 5 years who are receiving at least 2 cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment of up to 5 days duration. The study is designed to evaluate the safety and PK of transdermal granisteron (Sancuso(R) patch) in a pediatric population (aged 2 to 5 years) using a population PK approach.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
granisetron transdermal system
IV granisetron
Plasma concentration
Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.
Time frame: Up to 7 days
Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy
Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment
Time frame: Through study completion, an average of 8 weeks
Number of participants with change in physical assessment including height, weight, BMI and BSA
Change in height and weight to calculate BMI and BSA
Time frame: Through study completion, an average of 8 weeks
Number of participants with change in vital signs
Change in pulse, systolic and diastolic blood pressure measurements
Time frame: Through study completion, an average of 8 weeks
Number of participants with change in ECG parameters
12 lead ECGs will be conducted to time match PK samples after at least 5 minutes supine rest
Time frame: Through study completion, an average of 8 weeks
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