Pediatric CINV Trial MK-0869 Protocol 208

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

• IRAS ID

  81757

• Contact name

  Julia Chisholm

• Sponsor organisation

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

• Eudract number

  2011-000651-16

• Clinicaltrials.gov Identifier

  NCT01362530

• Research summary

  Nausea and vomiting remains a major problem in a significant number of children undergoing chemotherapy despite the wide use of a 5-hydroxytryptamine (5-HT) type 3 receptor antagonist (5-HT3 antagonist)(i.e., ondansetron) with or without corticosteroids for antiemetic prophylaxis. Oral aprepitant (EMEND), MK-0869 is a potent and selective substance P (neurokinin 1 (NK1) ?? receptor) antagonist that's given in combination with other antiemetic agents for the prevention of chemotherapy induced nausea and vomiting (CINV). Aprepitant has received marketing approval in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy (HEC), including high dose cisplatin; and for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC). For both HEC and MEC, the currently approved 3-day dosing regimen in adults for orally administered aprepitant is 125 mg on Day 1 followed by 80 mg on Days 2 and 3, in combination with a 5-HT3 antagonist and dexamethasone. Aprepitant is not yet approved for use in children.Thus, there is an ongoing need to clarify the role of new anti-emetic agents, such as aprepitant, in alleviating CINV in children receiving emetogenic chemotherapy.The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in paediatric patients, from birth to 17 years of age, receiving emetogenic chemotherapy for a documented malignancy.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/1437

• Date of REC Opinion

  14 Oct 2011

• REC opinion

  Favourable Opinion