NCT01405924

Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)

EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of MEC in participants who previously experienced vomiting during the first cycle of MEC.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	Fosaprepitant dimeglumine	Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2
DRUG	5-HT3 RA	5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
DRUG	Dexamethasone	Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
DRUG	Rescue medication	Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.

Timeline

• Start date: 2011-10-25
• Primary completion: 2013-12-06
• Completion: 2013-12-06
• First posted: 2011-07-29
• Last updated: 2018-08-27
• Results posted: 2014-10-29