PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

August 31, 2017

Primary Completion Date

September 30, 2019

Study Completion Date

September 30, 2019

Conditions
Chemotherapy-induced Nausea and Vomiting (CINV)
Interventions
DRUG

Netupitant

Netupitant 1.33 mg/kg oral suspension up to a maximum of 100 mg

DRUG

Palonosetron

Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg

DRUG

Netupitant

Netupitant 4 mg/kg oral suspension up to a maximum of 300 mg

DRUG

Palonosetron

Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg

Trial Locations (17)

19803

Nemours/A.I. duPont Hospital for Children, Wilmington

29425

Medical University of South Carolina, Charleston

32207

Nemours Children's Clinic, Jacksonville

32827

Nemours Children's Hospital - Orlando, Orlando

49100

Dnipropetrovsk Regional Children's Clinical Hospital, Dnipro

394024

Voronezh Regional Children's Cinical Hospital #1, Voronezh

04074

Maine Medical Center - Cancer Medicine and Blood Disorders - Scarborough, Scarborough

Unknown

Chelyabinsk Regional Children's Clinical Hospital, Chelyabinsk

Children's Territorial Clinical Hospital, Krasnodar

Dmitry Rogachev National Scientific and Practical Center for Pediatric Hematology, Oncology and Immunology, Moscow

City Clinical Hospital #31, Saint Petersburg

First I.P. Pavlov State Medical University of St. Petersburg, Saint Petersburg

Regional Children's Clinical Hospital #1, Yekaterinburg

University Children's Hospital, Center for Pediatrics, Department of Hematology and Oncology, Belgrade

Clinical Center Nis, Clinic of Pediatric Internal Diseases, Niš

National Institute of Cancer, Research Department of Pediatric Oncology, Kyiv

West Ukrainian Specialized Children's Medical Center, Department of Pediatric Surgery, Lviv

Sponsors
All Listed Sponsors
lead

Helsinn Healthcare SA

INDUSTRY