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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Vomiting; Nausea

Treatments: Drug: 5-HT3 RA; Drug: Dexamethasone; Drug: Fosaprepitant dimeglumine; Drug: Rescue medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405924

0517-030

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

Fosaprepitant 150 mg

Experimental group

Description:

Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy

Treatment:

Drug: Dexamethasone

Drug: 5-HT3 RA

Drug: Fosaprepitant dimeglumine

Drug: Rescue medication