clinical trial · NCT01596413
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years
Kyowa Kirin Pharmaceutical Development Ltd·phase1·withdrawn
Chemotherapy Induced Nausea and VomitingSancusoIV granisetron
brief summary
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.
started
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primary completion
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completion
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last updated
Jul 26, 2024
detailed description
This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 6 to 12 years of age 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 granisetron (Sancuso® patch) in a pediatric population (aged 6 to 12 years), using a population PK approach.
official title
An Open-label, Cross-over, Pharmacokinetic Study to Assess the Safety and Pharmacokinetics of Transdermal Granisetron (Sancuso® Patch) and IV Granisetron in a Pediatric Oncology Population (Aged 6 to 12 Years)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol