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

NCT ID: NCT01405924

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-25
• Study Completion Date: 2013-12-06

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fosaprepitant 150 mg

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

Group Type: EXPERIMENTAL

Fosaprepitant dimeglumine

Intervention Type: DRUG

Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2

5-HT3 RA

Intervention Type: DRUG

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.

Dexamethasone

Intervention Type: DRUG

Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.

Rescue medication

Intervention Type: DRUG

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.

Interventions

Fosaprepitant dimeglumine

Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MK-0517, EMEND® IV

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0517-030

Identifier Type: -

Identifier Source: org_study_id