Palonosetron in CINV prevention paediatric patients PALO-10-20 v3.0

• Research type

  Research Study

• Full title

  A multicentre, randomised, 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 paediatric patients undergoing single and repeated cycles of MEC or HEC.

• IRAS ID

  70327

• Contact name

  Martin Hewitt

• Sponsor organisation

  Helsinn Healthcare SA

• Eudract number

  2010-022872-30

• Research summary

  This is a study to look at how well two different doses of the anti-sickness drug called palonosetron prevent sickness in children receiving chemotherapy, how well they are tolerated and to check on for any side effects they might have, comparing these with the usual anti-sickness drug called ondansetron.Palonosetron is approved in several countries for use in adults, but not in children. Ondansetron is approved for adults and children in many countries. Patients suitable to enter the study will be randomly assigned to one of three treatment groups to receive either one dose of palonosetron (10 mcg/kg), one dose of palonosetron (20mcg/kg) or three doses of ondansetron (0.15 mg/kg).Palonosetron, ondansetron and placebo will be given through an intravenous (IV) line (a small tube used to give medicines into a vein), that will be used for the chemotherapy administration, on Day 1 of each cycle, with a maximum of 4 chemotherapy cycles per patient. Patients may also receive dexamethasone (a standard steroid drug widely used to control nausea and vomiting), except if this is contraindicated or if corticosteroids are already included in their chemotherapy treatment.The planned duration of the study is a maximum of 32 days for the first cycle. For patients performing multiple chemotherapy cycles the total study duration will be up to 16.5 weeks. For neonates an open-label sub-study will be carried out starting with palonosetron doses of 3 mcg/kg and only palonosetron active treatment will be given.All tests performed will be normal clinical procedures (assessment of blood chemistry and haematology, urinalysis, electrocardiography) Pregnancy tests will be performed as appropriate and all patients will complete a diary. A Pharmacokinetic (PK) sub-study will be conducted (additional consent required).This will look at how the drug is processed,broken down and removed by the body

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  11/YH/0216

• Date of REC Opinion

  4 Aug 2011

• REC opinion

  Further Information Favourable Opinion