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)

NCT ID: NCT01636947

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 494 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-12
• Study Completion Date: 2014-08-04

Brief Summary

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aprepitant Regimen

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.

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3

Ondansetron

Intervention Type: DRUG

Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3

Dexamethasone

Intervention Type: DRUG

Dexamethasone (20 mg or 12 mg, PO) on Day 1

Ondansetron Placebo

Intervention Type: DRUG

Ondansetron Placebo (PO, BID) on Days 2 and 3

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

Intervention Type: DRUG

Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).

Control Regimen

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.

Group Type: ACTIVE_COMPARATOR

Aprepitant Placebo

Intervention Type: DRUG

Aprepitant Placebo (PO, QD) on Days 1, 2, and 3

Ondansetron

Intervention Type: DRUG

Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3

Dexamethasone

Intervention Type: DRUG

Dexamethasone (20 mg or 12 mg, PO) on Day 1

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

Intervention Type: DRUG

Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).

Interventions

Aprepitant

Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3

Intervention Type: DRUG

Aprepitant Placebo

Aprepitant Placebo (PO, QD) on Days 1, 2, and 3

Intervention Type: DRUG

Ondansetron

Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3

Intervention Type: DRUG

Dexamethasone

Dexamethasone (20 mg or 12 mg, PO) on Day 1

Intervention Type: DRUG

Ondansetron Placebo

Ondansetron Placebo (PO, BID) on Days 2 and 3

Intervention Type: DRUG

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

Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).

Intervention Type: DRUG

Other Intervention Names

MK-0869; EMEND® PO; ZOFRAN®; dexamethasone sodium phosphate; dexamethasone acetate; Decadron; Dexasone; Diodex; Hexadrol; Maxidex

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• 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

References

Kim JE, Jang JS, Kim JW, Sung YL, Cho CH, Lee MA, Kim DJ, Ahn MJ, Lee KY, Sym SJ, Lim MC, Jung H, Cho EK, Min KW. Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. Support Care Cancer. 2017 Mar;25(3):801-809. doi: 10.1007/s00520-016-3463-0. Epub 2016 Nov 8.

Reference Type: RESULT

PMID: 27826874 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-0869-225

Identifier Type: OTHER

Identifier Source: secondary_id

0869-225

Identifier Type: -

Identifier Source: org_study_id