Spots Global Cancer Trial Database for PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting
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Trial Identification
Brief Title: PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting
Official Title: A Multicenter Multinational Randomized Double Blind PK/PD Dose-finding Study of Oral Netupitant Given With Oral Palonosetron in Pediatric Cancer Patients for Prevention of Nausea and Vomiting Associated With Emetogenic Chemotherapy
Study ID: NCT03204279
Study Description
Brief Summary: This study is Phase 2 pharmacokinetic (PK) and pharmacodynamic (PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Two different netupitant dosages will be tested in patients aged from 3 months to \< 18 years: 1.33 mg/kg up to a maximum of 100 mg, and 4 mg/kg up to a maximum of 300 mg. All netupitant doses in all age classes will be concomitantly administered with palonosetron 20 μg/kg (up to a maximum dose of 1.5 mg) which is the IV palonosetron dose approved by USA FDA for the pediatric population. The primary objective is to investigate the PK/PD relationship between netupitant exposure (AUC, Cmax) and antiemetic efficacy (CR in delayed phase) after a single oral netupitant administration, concomitantly with oral palonosetron in pediatric cancer patients receiving Moderately Emetogenic Chemotherapy (MEC) or Highly Emetogenic Chemotherapy (HEC) cycles. Efficacy parameter to be used in the correlation is the proportion of patients with Complete Response (CR i.e., no emetic episodes and no rescue medication) during (\> 24-120 h after the start of chemotherapy on Day 1). The secondary objectives are to assess the safety and tolerability after single oral administration of netupitant given concomitantly with a single oral administration of palonosetron; to evaluate the pharmacokinetic (AUC, Cmax, tmax and t1/2) of oral palonosetron at the fixed dose of 20 μg/kg in pediatric patients with the concomitant administration of netupitant. A total of 92 pediatric cancer patients receiving either HEC or MEC will be enrolled in the study.
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Nemours/A.I. duPont Hospital for Children, Wilmington, Delaware, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Nemours Children's Hospital - Orlando, Orlando, Florida, United States
Maine Medical Center - Cancer Medicine and Blood Disorders - Scarborough, Scarborough, Maine, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Chelyabinsk Regional Children's Clinical Hospital, Chelyabinsk, , Russian Federation
Children's Territorial Clinical Hospital, Krasnodar, , Russian Federation
Dmitry Rogachev National Scientific and Practical Center for Pediatric Hematology, Oncology and Immunology, Moscow, , Russian Federation
City Clinical Hospital #31, St. Petersburg, , Russian Federation
First I.P. Pavlov State Medical University of St. Petersburg, St. Petersburg, , Russian Federation
Voronezh Regional Children's Cinical Hospital #1, Voronezh, , Russian Federation
Regional Children's Clinical Hospital #1, Yekaterinburg, , Russian Federation
University Children's Hospital, Center for Pediatrics, Department of Hematology and Oncology, Belgrade, , Serbia
Clinical Center Nis, Clinic of Pediatric Internal Diseases, Nis, , Serbia
Dnipropetrovsk Regional Children's Clinical Hospital, Dnipro, , Ukraine
National Institute of Cancer, Research Department of Pediatric Oncology, Kyiv, , Ukraine
West Ukrainian Specialized Children's Medical Center, Department of Pediatric Surgery, Lviv, , Ukraine
Contact Details
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