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

NCT01442376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2014-08-07

Study results available
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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.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

Palonosetron

Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg

DRUG

Palonosetron

Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg

DRUG

Ondansetron

Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg

DRUG

Placebo to Ondansetron

DRUG

Placebo to Ondansetron

DRUG

Placebo to Palonosetron

Sponsors & Collaborators

  • Helsinn Healthcare SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • United States
  • Argentina
  • Austria
  • Bulgaria
  • Chile
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Peru
  • Poland
  • Romania
  • Russia
  • Serbia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01442376 on ClinicalTrials.gov