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 AM1) (KMEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01636947
First received: July 5, 2012
Last updated: July 9, 2014
Last verified: July 2014

July 5, 2012
July 9, 2014
December 2012
October 2014   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01636947 on ClinicalTrials.gov Archive Site
  • Number of Participants with a Complete Response - Overall, Acute, and Delayed [ Time Frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Number of Participants with No Vomiting and No Significant Nausea [ Time Frame: Days 1 to Day 5 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Participants with One or More Clinical Adverse Events [ Time Frame: Day 1 through Day 29 ] [ Designated as safety issue: Yes ]
  • No Vomiting - Acute and Delayed [ Time Frame: Day 1, Day 2 to Day 5 ] [ Designated as safety issue: No ]
    Acute is defined as 0 to 24 hours following initiation of chemotherapy and Delayed is 25 to 120 hours following initiation of chemotherapy.
Same as current
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 AM1) (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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Nausea
  • Vomiting
  • Drug: Aprepitant

    Aprepitant (125 mg, per os [by mouth, PO], once daily [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, intravenous [IV], qd) on Day 1
    Other Name: ZOFRAN®
  • Drug: Dexamethasone
    Dexamethasone (12 mg, PO) on Day 1
    Other Names:
    • dexamethasone sodium phosphate
    • dexamethasone acetate
    • Decadron
    • Dexasone
    • Diodex
    • Hexadrol
    • Maxidex
  • Drug: Dexamethasone
    Dexamethasone (20 mg, PO) on Day 1
    Other Names:
    • dexamethasone sodium phosphate
    • dexamethasone acetate
    • Decadron
    • Dexasone
    • Diodex
    • Hexadrol
    • Maxidex
  • Drug: Ondansetron Placebo
    Ondansetron Placebo (PO, bis in die [twice a day, 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-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).
  • Drug: Ondansetron
    Ondansetron (8 mg, PO, bid) Day 2 and Day 3
    Other Name: ZOFRAN®
  • Experimental: Aprepitant Regimen
    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
    Interventions:
    • Drug: Aprepitant Placebo
    • Drug: Ondansetron
    • Drug: Dexamethasone
    • Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
    • Drug: Ondansetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
492
October 2014
October 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
Both
21 Years and older
No
Contact: Toll Free Number 1-888-577-8839
Korea, Republic of
 
NCT01636947
0869-225, MK-0869-225
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

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