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
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Drug: Aprepitant
Drug: Aprepitant Placebo
Drug: Ondansetron
Drug: Dexamethasone
Drug: Ondansetron Placebo
Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 492
Study Start Date: December 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aprepitant Regimen 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: 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: 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).
Active Comparator: Control Regimen 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 (20 mg, PO) on Day 1
Other Names:
  • dexamethasone sodium phosphate
  • dexamethasone acetate
  • Decadron
  • Dexasone
  • Diodex
  • Hexadrol
  • Maxidex
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®

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636947

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Cem Ozesen    90 212 3361260      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01636947     History of Changes
Other Study ID Numbers: 0869-225, MK-0869-225
Study First Received: July 5, 2012
Last Updated: July 9, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Merck Sharp & Dohme Corp.:
chemotherapy
nausea
vomiting
emetogenic
cancer
antiemetics
tumor

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Metoclopramide
Alizapride
Ondansetron
Granisetron
Tropisetron
Dolasetron mesylate
Aprepitant
Dexamethasone 21-phosphate
Sodium phosphate
BB 1101
Emetics
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 29, 2014