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

• Status: Terminated
• Trial end date: 2013-12-06
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant

Criteria

Inclusion Criteria:

• Diagnosed with either breast or gynecological cancer

• Receiving either AC-like or CT MEC

• Experienced at least 1 episode of vomiting or retching during the first 5 days following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant

• No change in chemotherapy at Cycle 2

• No change in Cycle 1 antiemetic regimen at Cycle 2

• Eastern Cooperative Oncology Group (ECOG) status 0-1

Exclusion Criteria:

• Requires increase in systemic corticosteroid therapy

• Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy

• Received or will receive radiation therapy to the abdomen or pelvis in the week prior to Visit 1 or in Days 1-6 following chemotherapy

• Vomited in the 24 hours prior to Treatment Day 1

• Pregnant or breast-feeding

• Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks

• Symptomatic central nervous system metastasis

• History of other malignancies in the last 2 years