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Completed

NCT Number: NCT01636947

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)

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.

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Key information

Conditions

Nausea Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

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

Other names: MK-0869, EMEND® PO

Aprepitant Placebo

Drug

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

ondansetron

Drug

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

Other names: ZOFRAN®

Dexamethasone

Drug

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

Other names: dexamethasone sodium phosphate, dexamethasone acetate, Decadron, Dexasone, Diodex, Hexadrol, Maxidex

Ondansetron Placebo

Drug

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

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

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).

Primary outcomes

  1. The Percentage of Participants With No Vomiting - Overall Stage

    Time frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

    A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).

Secondary outcomes

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

    Time frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

    A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.

  2. Number of Emetic Events - Overall Stage

    Time frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)

    The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented.

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

    Time frame: Days 1 to Day 5

    Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: "How much nausea have you had over the last 24 hours?" The left end of the scale (0 mm) was labeled "no nausea," and the right end of the scale (100 mm) is labeled "nausea as bad as it could be." In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm.

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

    Time frame: Day 6

    The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, "No Impact" on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC.

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

    Time frame: Day 1 to Day 5

    The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.

  6. Percentage of Participants With One or More Clinical Adverse Event

    Time frame: Day 1 through Day 29 (Up to 28 days after first dose of study drug)

    An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event.

  7. Percentage of Participants With No Vomiting - Acute and Delayed Stages

    Time frame: Day 1, Day 2 to Day 5

    A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Acronym: KMEC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2012
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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