Phase 4
N=494
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)
Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT01636947 ↗Enrolled (actual)
494
Serious AEs
8.4%
Results posted
Jul 2015
Primary outcome: Primary: The Percentage of Participants With No Vomiting - Overall Stage — 77.2; 72.0 Percentage of Participants — p=0.191
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aprepitant (Drug); Aprepitant Placebo (Drug); Ondansetron (Drug); Dexamethasone (Drug); Ondansetron Placebo (Drug); Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride). (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With No Vomiting - Overall Stage |
77.2; 72.0 | 0.191 |
| SECONDARY Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages |
73.4; 70.4; 95.8; 97.9; 74.3; 71.2 | 0.458 |
| SECONDARY Number of Emetic Events - Overall Stage |
54; 68 | — |
| SECONDARY Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage |
76.4; 72.4 | — |
| SECONDARY Percentage of Participants With No Impact on Daily Life - Overall Stage |
76.8; 73.8 | — |
| SECONDARY Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages |
84.8; 87.7; 98.7; 99.2; 84.8; 88.5 | — |
| SECONDARY Percentage of Participants With One or More Clinical Adverse Event |
56.2; 53.2 | — |
| SECONDARY Percentage of Participants With No Vomiting - Acute and Delayed Stages |
95.8; 98.8; 78.5; 72.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT01636947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.