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)
Phase 4
21 Years
N/A
21 Years
N/A
Open (Enrolling)
Both
Nausea, Vomiting
Both
Nausea, Vomiting
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
The Proportion of Participants with Overall No Vomiting for the Overall Stage
Outcome Time Frame:
Hour 0 on Day 1 to Day 5 (approximately 120 hours)
Safety Issue:
No
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
0869-225
NCT ID:
NCT01636947
Start Date:
December 2012
Completion Date:
October 2014
Related Keywords:
- Nausea
- Vomiting
- chemotherapy
- nausea
- vomiting
- emetogenic
- cancer
- antiemetics
- tumor
- Nausea
- Vomiting
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