A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Vomiting; Nausea

Treatments: Drug: Aprepitant Placebo; Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).; Drug: Ondansetron Placebo; Drug: Aprepitant; Drug: Ondansetron; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636947

MK-0869-225 (Other Identifier)

0869-225

Details and patient eligibility

About

This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens.

The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.

Enrollment: 494 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed malignant disease
• Scheduled to receive a single dose of one or more of moderately emetogenic chemotherapeutic agents during Cycle 1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or Karnofsky score ≥60
• Predicted life span ≥4 months
• Laboratory values demonstrating adequate hematologic status
• Premenopausal females must not be pregnant or lactating and must agree to use effective birth control

Exclusion criteria

• Received chemotherapy within 6 months prior to starting on study drugs
• Scheduled to receive subsequent treatment due to a refractory response to first or second line chemotherapy
• Received an investigational drug within 30 days prior to starting on study drugs
• Radiation therapy to the abdomen or pelvis in the week prior to starting on study drugs
• Vomiting in the 24 hours prior to starting on study drugs
• Active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy
• Known hypersensitivity to Aprepitant (EMEND®), Dexamethasone or 5-HT3 receptor antagonists
• Presentation with gastrointestinal obstruction symptoms
• Symptomatic primary or metastatic central nervous system malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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494 participants in 2 patient groups

Aprepitant Regimen

Experimental group

Description:

Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.

Treatment:

Drug: Dexamethasone

Drug: Ondansetron

Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).

Drug: Aprepitant

Drug: Ondansetron Placebo

Control Regimen

Active Comparator group

Description:

Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.

Treatment:

Drug: Dexamethasone

Drug: Aprepitant Placebo

Drug: Ondansetron

Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).