A Phase 1 interventional study of Sancuso and IV granisetron in Chemotherapy Induced Nausea and Vomiting, sponsored by Kyowa Kirin Pharmaceutical Development Ltd. Withdrawn. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Kyowa Kirin Pharmaceutical Development Ltd · Phase 1, Interventional, and Treatment
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
Browse Vomiting studies →Kyowa Kirin Pharmaceutical Development Ltd is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.
Exclusion Criteria:
patch
Drug: Sancuso
IV
Drug: IV granisetron
granisetron transdermal system
IV granisetron
Also known as: IV
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
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Pharmaceutical Development Ltd