Clinical Trials Logo
  1. Home
  2. Chemotherapy
  3. NCT01442376

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC

Clinical Trial Summary

The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.

Clinical Trial Description

For neonates (<28 days, full term) an open-label sub-study will be conducted to assess exposure and tolerability in this age group with escalating doses of palonosetron, starting with 3 mcg/kg to the first three or more neonates included in the study. If this dose is shown to be safe and well tolerated then the following three neonates will be treated with a dose of 10 mcg/kg. If also this dose is safe and well tolerated, then the following three neonates will be treated with a dose of 20 mcg/kg. If this last dose is also shown to be safe and well tolerated, then all the following neonates will be randomized to the main study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01442376
Study type Interventional
Source Helsinn Healthcare SA
Contact
Status Completed
Phase Phase 3
Start date September 2011
Completion date November 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT04054193 - Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045) Phase 4
Recruiting NCT04430361 - the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy Phase 2
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Completed NCT02285647 - An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant Phase 1
Terminated NCT01874119 - Fosaprepitant for N/V With High-dose Interleukin-2 for Metastatic Melanoma and Renal Cell Carcinoma Phase 2
Completed NCT01757210 - A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients N/A
Withdrawn NCT00891761 - A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy Phase 3
Completed NCT01031498 - Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting Phase 2
Terminated NCT02519842 - Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044) Phase 3
Recruiting NCT03232541 - The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting N/A
Completed NCT02909478 - Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer Phase 3
Terminated NCT03237611 - Low Dose Aprepitant for Patients Receiving Carboplatin Phase 2
Completed NCT03649230 - Observational Study on the Use of Akynzeo® in Patients Receiving HEC
Not yet recruiting NCT02933099 - Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting Phase 3
Completed NCT02557035 - An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting Phase 3
Completed NCT00787566 - Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting Phase 2
Completed NCT06121414 - Effectiveness of Laserpuncture and Standard Antiemetic on RINVR Scores in Adolescent Patients Undergoing Chemotherapy N/A
Completed NCT04918069 - Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN) Phase 2
Recruiting NCT05851625 - Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients N/A
Recruiting NCT05325190 - Granisetron Transdermal Patch System for Prevention of CINV by CapeOX Phase 2