NauseaPhase 4KMECNCT01636947
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)
A Phase 4 study testing Aprepitant, Ondansetron and Dexamethasone in people with Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Aprepitant, Ondansetron and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 494 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2012to 4 Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Known hypersensitivity to Aprepitant (EMEND®), Dexamethasone or 5-HT3 receptor antagonists
- Presentation with gastrointestinal obstruction symptoms
- Symptomatic primary or metastatic central nervous system malignancy
About this study
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)
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.
- Being tested
- Aprepitant, Aprepitant Placebo, Ondansetron, Dexamethasone, Ondansetron Placebo
- Keywords
- chemotherapy, nausea, vomiting, emetogenic, cancer, antiemetics, tumor
- Medical subject headings
- Nausea, Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called MK-0869, EMEND® PO
Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3
Aprepitant PlaceboDrug
Aprepitant Placebo (PO, QD) on Days 1, 2, and 3
OndansetronDrug
Also called ZOFRAN®
Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3
DexamethasoneDrug
Also called dexamethasone sodium phosphate, dexamethasone acetate, Decadron, Dexasone
Dexamethasone (20 mg or 12 mg, PO) on Day 1
Ondansetron PlaceboDrug
Ondansetron Placebo (PO, BID) on Days 2 and 3
Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).Drug
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-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant Regimen | Experimental | Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3. Receives: Drug: Aprepitant; Drug: Ondansetron; Drug: Dexamethasone; Drug: Ondansetron Placebo; Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride). |
| Control Regimen | Active comparator | Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3. Receives: Drug: Aprepitant Placebo; Drug: Ondansetron; Drug: Dexamethasone; Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With No Vomiting - Overall Stage
A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).
Measured: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
Secondary outcomes (7)
Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages
A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.
Measured: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
Number of Emetic Events - Overall Stage
The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented.
Measured: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage
Nausea was to 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) was 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 was defined as a VAS nausea rating <25 mm.
Measured: Days 1 to Day 5
Percentage of Participants With No Impact on Daily Life - Overall Stage
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 was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC.
Measured: Day 6
Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages
The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.
Measured: Day 1 to Day 5
Percentage of Participants With One or More Clinical Adverse Event
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event.
Measured: Day 1 through Day 29 (Up to 28 days after first dose of study drug)
Percentage of Participants With No Vomiting - Acute and Delayed Stages
A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.
Measured: Day 1, Day 2 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study start12 Dec 2012
- Primary completion4 Aug 2014
- Study completion4 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636947
- Sponsor's protocol ID
- 0869-225
- Other IDs
- MK-0869-225
- Acronym
- KMEC
- Status last verified
- Aug 2018
- First submitted
- 5 Jul 2012
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 27826874
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01636947
- Acronym / sponsor ID
- KMEC / 0869-225
- Keywords
- chemotherapy, nausea, vomiting, emetogenic, cancer, antiemetics, tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2012 (actual)
- Primary completion
- 4 Aug 2014 (actual)
- Study completion
- 4 Aug 2014 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 30 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant Regimen | Experimental | Drug: Aprepitant, Drug: Ondansetron, Drug: Dexamethasone, Drug: Ondansetron Placebo, Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3. |
| Control Regimen | Active comparator | Drug: Aprepitant Placebo, Drug: Ondansetron, Drug: Dexamethasone, Drug: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantAlso: MK-0869, EMEND® POAprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3 | Drug | Aprepitant Regimen |
| Aprepitant PlaceboAprepitant Placebo (PO, QD) on Days 1, 2, and 3 | Drug | Control Regimen |
| OndansetronAlso: ZOFRAN®Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3 | Drug | Aprepitant Regimen, Control Regimen |
| DexamethasoneAlso: dexamethasone sodium phosphate, dexamethasone acetate, Decadron, DexasoneDexamethasone (20 mg or 12 mg, PO) on Day 1 | Drug | Aprepitant Regimen, Control Regimen |
| Ondansetron PlaceboOndansetron Placebo (PO, BID) on Days 2 and 3 | Drug | Aprepitant Regimen |
| 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-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride). | Drug | Aprepitant Regimen, Control Regimen |
Primary outcome
The Percentage of Participants With No Vomiting - Overall Stage
Time frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).
7 secondary outcomes
Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages
Time frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
Number of Emetic Events - Overall Stage
Time frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage
Time frame: Days 1 to Day 5
Percentage of Participants With No Impact on Daily Life - Overall Stage
Time frame: Day 6
Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages
Time frame: Day 1 to Day 5
Percentage of Participants With One or More Clinical Adverse Event
Time frame: Day 1 through Day 29 (Up to 28 days after first dose of study drug)
Percentage of Participants With No Vomiting - Acute and Delayed Stages
Time frame: Day 1, Day 2 to Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27826874Kim 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.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant, Ondansetron and Dexamethasone in people with Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Participants With No Vomiting - Overall Stage (time frame: Hour 0 on Day 1 to Day 5 (approximately 120 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01636947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.