Clinical Trials Logo
  1. Home
  2. Chemotherapy
  3. NCT01596426

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

Clinical Trial Summary

The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01596426
Study type Interventional
Source Kyowa Kirin Pharmaceutical Development Ltd
Contact
Status Withdrawn
Phase Phase 1
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06065722 - Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy Phase 2
Completed NCT01362530 - A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208) Phase 3
Recruiting NCT02205164 - Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients Phase 2
Completed NCT01596400 - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years Phase 1
Not yet recruiting NCT04873284 - Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients N/A
Completed NCT00642512 - Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Phase 3
Recruiting NCT02097823 - Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy Phase 2
Completed NCT01402024 - Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy Phase 3
Completed NCT00211601 - Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041) N/A
Completed NCT05792228 - A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting N/A
Withdrawn NCT01596413 - Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years Phase 1