Clinical trial 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Keywords: chemotherapy
nausea
vomiting
emetogenic
cancer
antiemetics
tumor
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 494
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Percentage of Participants With No Vomiting - Overall Stage
timeFrame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
Secondary outcomes:
measure: Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages
timeFrame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
measure: Number of Emetic Events - Overall Stage
timeFrame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
measure: Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage
timeFrame: Days 1 to Day 5
measure: Percentage of Participants With No Impact on Daily Life - Overall Stage
timeFrame: Day 6
measure: Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages
timeFrame: Day 1 to Day 5
measure: Percentage of Participants With One or More Clinical Adverse Event
timeFrame: Day 1 through Day 29 (Up to 28 days after first dose of study drug)
measure: Percentage of Participants With No Vomiting - Acute and Delayed Stages
timeFrame: Day 1, Day 2 to Day 5
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.