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)

Condition(s) targeted: Nausea; Vomiting

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

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Official title: A Korean Multicenter, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies (MEC, Non-AC Regimes) With Broad Range of Tumor Types (KMEC Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The Percentage of Participants With No Vomiting - Overall Stage

Secondary outcome:

Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages

Number of Emetic Events - Overall Stage

Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage

Percentage of Participants With No Impact on Daily Life - Overall Stage

Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages

Percentage of Participants With One or More Clinical Adverse Event

Percentage of Participants With No Vomiting - Acute and Delayed Stages

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: December 2012
Last updated: July 2, 2015