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Granisetron

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Sancuso

IV granisetron

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.

Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 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 2 to 5 Years)

Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.

Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment

Change in height and weight to calculate BMI and BSA

Change in pulse, systolic and diastolic blood pressure measurements

12 lead ECGs will be conducted to time match PK samples after at least 5 minutes supine rest

Kyowa Kirin Pharmaceutical Development Ltd

Pharmaceutical Solutions

Transdermal Patch 34.3mg graniestron per patch, size 52cm2 Dose: 3.1mg/24 hrs

Aqueous solution for IV administration

1 mg/mL ampoules Dose: 0.01mg/kg (maximum 1 mg)

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

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.

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)

Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment.

Change in pulse, systolic and diastolic blood pressures measurements

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years	NCT01596426	Chemotherapy In...	Sancuso IV granisetron	2 Years - 5 Years	Kyowa Kirin Pharmaceutical Development Ltd
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years	NCT01596426	Chemotherapy In...	Sancuso IV granisetron	2 Years - 5 Years	Kyowa Kirin Pharmaceutical Development Ltd
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years	NCT01596413	Chemotherapy In...	Sancuso IV granisetron	6 Years - 12 Years	Kyowa Kirin Pharmaceutical Development Ltd

Spots Global Cancer Trial Database for sancuso

Every month we try and update this database with for sancuso cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sancuso

Every month we try and update this database with for sancuso cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sancuso cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.