NCT01596413

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

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)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chemotherapy Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Sancuso	granisetron transdermal system
DRUG	IV granisetron	IV

Timeline

• First posted: 2012-05-11
• Last updated: 2024-07-26