Fosaprepitant PK/PD CINV in Pediatric Cancer Patients

• Research type

  Research Study

• Full title

  A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Emetogenic Chemotherapy

• IRAS ID

  113172

• Contact name

  Barry Pizer

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2012-002340-24

• Research summary

  Nausea and vomiting remains a major problem for children undergoing chemotherapy despite the wide use of 5-HT3 antagonists (such as ondansetron) for the prevention of chemotherapy induced nausea a vomiting (CINV). MK0517 also known as fosaprepitant is an intravenous (IV) version of an approved oral drug known as aprepitant which is given over three days for the prevention of CINV in adults. In adults a single IV dose of fosaprepitant 150 mg plus a 5-HT3 antagonist plus corticosteroid, has shown non-inferiority to the 3-day oral aprepitant regimen. Fosaprepitant 150 mg has been approved in many countries worldwide (including the UK) as a convenient single-dose alternative to 3-day oral aprepitant for the prevention of CINV. However, fosaprepitant is not yet approved for use in children. The purpose of this study is to determine the appropriate dosing regimen of fosaprepitant for the prevention of CINV in children. 256 participants aged from birth to 17 years who are scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of causing nausea and vomiting will be randomly assigned to one of four treatment groups. Prior to receiving their scheduled cycle 1 chemotherapy three of the treatment groups will receive a single IV infusion of MK0517 (each group will receive a different dose of MK0517) in combination with IV ondansetron and one group will receive placebo in combination with IV ondansetron. IV dexamethasone may also be given at the discretion of the investigator. Continuation in the study for Cycles 2 to 6 will be optional. In cycles 2 to 6 all participants will receive a single IV dose of MK0517 plus a 5-HT3 antagonist with or without dexamethosone. The company that makes MK0517 is the study sponsor. It is anticipated that 3 UK NHS hospital sites will participate in the study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0717

• Date of REC Opinion

  22 Nov 2012

• REC opinion

  Further Information Favourable Opinion