Single Dose of MK-0517 for Prevention of CINV in Pediatric Subjects

Update Il y a 4 ans
Reference: EUCTR2014-001783-34

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

Efficacy: To compare the single IV dose of fosaprepitant (in combination with ondansetron) to the ondansetron alone regimen with respect to the efficacy endpoint of Complete Response in the delayed phase (>24 to 120 hours) following the initiation of emetogenic chemotherapy in Cycle 1. Safety: To assess the safety and tolerability of the fosaprepitant regimen in pediatric subjects who are receiving emetogenic chemotherapy.


Inclusion criteria

  • Chemotherapy-induced nausea and vomiting (CINV) associated with emetogenic chemotherapy