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Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years

Chemotherapy Induced Nausea and Vomiting Clinical Trial

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)

Clinical Trial Summary

The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01596413
Study type Interventional
Source Kyowa Kirin Pharmaceutical Development Ltd
Contact
Status Withdrawn
Phase Phase 1
View Details
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