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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) (KMEC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636947
First Posted: July 10, 2012
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
July 5, 2012
July 10, 2012
July 2, 2015
July 30, 2015
June 5, 2017
December 12, 2012
August 4, 2014   (Final data collection date for primary outcome measure)
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).
The Proportion of Participants with Overall No Vomiting for the Overall Stage [ Time Frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours) ]
Complete list of historical versions of study NCT01636947 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of Participants with a Complete Response - Overall, Acute, and Delayed [ Time Frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours) ]
    For this study, a complete response is defined as no vomiting and no use of a rescue therapy.
  • Time to First Vomiting Event Overall [ Time Frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours) ]
  • Number of Participants with No Vomiting and No Significant Nausea [ Time Frame: Days 1 to Day 5 ]
    Nausea will 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) is 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 is defined as a VAS nausea rating <25 mm.
  • Number of Participants with No Impact on Daily Life - Overall [ Time Frame: Day 1 to Day 5 ]
    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 is defined as an average item score of > 6 on the 7-point scale (total score >108).
  • Number of Participants with No Use of a Rescue Therapy - Overall, Acute, and Delayed [ Time Frame: Day 1 to Day 5 ]
  • Number of Participants with One or More Clinical Adverse Events [ Time Frame: Day 1 through Day 29 ]
  • No Vomiting - Acute and Delayed [ Time Frame: Day 1, Day 2 to Day 5 ]
    Acute is defined as 0 to 24 hours following initiation of chemotherapy and Delayed is 25 to 120 hours following initiation of chemotherapy.
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Nausea
  • Vomiting
  • Drug: Aprepitant
    Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3
    Other Names:
    • MK-0869
    • EMEND® PO
  • Drug: Aprepitant Placebo
    Aprepitant Placebo (PO, QD) on Days 1, 2, and 3
  • Drug: Ondansetron
    Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3
    Other Name: ZOFRAN®
  • Drug: Dexamethasone
    Dexamethasone (20 mg or 12 mg, PO) on Day 1
    Other Names:
    • dexamethasone sodium phosphate
    • dexamethasone acetate
    • Decadron
    • Dexasone
    • Diodex
    • Hexadrol
    • Maxidex
  • Drug: Ondansetron Placebo
    Ondansetron Placebo (PO, BID) on Days 2 and 3
  • 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).
  • Experimental: 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.
    Interventions:
    • Drug: Aprepitant
    • Drug: Ondansetron
    • Drug: Dexamethasone
    • Drug: Ondansetron Placebo
    • Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
  • Active Comparator: 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.
    Interventions:
    • Drug: Aprepitant Placebo
    • Drug: Ondansetron
    • Drug: Dexamethasone
    • Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
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. Erratum in: Support Care Cancer. 2017 Feb 14;:. Support Care Cancer. 2017 May;25(5):1741.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
494
August 4, 2014
August 4, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Korea, Republic of
 
NCT01636947
0869-225
MK-0869-225 ( Other Identifier: Merck protocol number )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP