Chemotherapy-induced Nausea and VomitingPhase 4NCT04054193
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
A Phase 4 study testing Fosaprepitant Dimeglumine, 5-HT3 antagonist and Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC at 26 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Fosaprepitant Dimeglumine, 5-HT3 antagonist and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 26 sitesin 9 countries
- Study dates
- 9 Sep 2019to 11 Feb 2021
- 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is receiving a moderately or highly emetogenic chemotherapy agent/regimen or a chemotherapy agent/regimen not previously tolerated due to vomiting
- Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age)
- Has a pre-existing functional central venous catheter available for study treatment administration
- Is fosaprepitant naïve
- Has a predicted life expectancy ≥3 months
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and agrees to not be sexually active or use a highly effective contraceptive method for at least 28 days prior to receiving study treatment, during the treatment period, and for at least 30 days (or local standard of care if longer) after the last dose of study treatment (including the optional cycles)
- Has a negative highly sensitive pregnancy test (urine or serum as required by local regulations) prior to the start of fosaprepitant administration in a given cycle if a WOCBP
- Weighs at least 6 kilograms (kg)
Who cannot join
- Will receive stem cell rescue therapy in conjunction with a study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant
- Is currently a user of any recreational or illicit drugs or has current evidence of drug or alcohol abuse or dependence as determined by the investigator
- Is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry
- Is pregnant or breast feeding
- Is allergic to fosaprepitant, aprepitant, or prescribed 5-HT3 antagonist
- Has an active infection (eg, pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (eg, diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or has any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study treatment or concomitant therapy to the participant
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- Is a WOCBP who has a positive pregnancy test at screening (Cycle 1) or on Day 1 of optional Cycles 2 or 3
- Has been started on systemic corticosteroid therapy within 72 hours prior to study treatment administration or is expected to receive a corticosteroid as part of the chemotherapy regimen. Exceptions apply
- Is taking excluded medications
- Has ever participated in a previous study of aprepitant or fosaprepitant or has taken a non-approved (investigational) drug within the last 4 weeks
- Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation
Trial locations and contacts
26 sites in 9 countries.
26 sites in 9 countries
United States5 sites
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1106)
Chicago, Illinois, 60611
Southern California Permanente Medical Group ( Site 1104)
Los Angeles, California, 90027
St. Jude Children's Research Hospital ( Site 1111)
Memphis, Tennessee, 38105
Children's Hospitals and Clinics of Minnesota ( Site 1109)
Minneapolis, Minnesota, 55404
Phoenix Childrens Hospital ( Site 1101)
Phoenix, Arizona, 85016
Russia4 sites
Chelyabinsk Regional Children Clinical Hospital ( Site 0705)
Chelyabinsk, Chelyabinsk Oblast, 454076
Blokhin National Medical Oncology ( Site 0701)
Moscow, Moscow, 115478
Dmitry Rogachev National Research Center ( Site 0704)
Moscow, Moscow, 117198
Clinical Research Center of specialized types medical care-Oncology ( Site 0706)
Saint Petersburg, Sankt-Peterburg, 197758
Greece3 sites
Athens Childrens Hospital Aglaia Kyriakou ( Site 0101)
Athens, Attica, 115 27
University of Athens - Aghia Sophia Childrens Hospital ( Site 0102)
Athens, Attica, 115 27
University General Hospital of Thessaloniki "AHEPA" ( Site 0103)
Thessaloniki, 546 36
Hungary3 sites
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0202)
Budapest, 1089
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0203)
Miskolc, Borsod-Abauj Zemplen county, 3526
Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0201)
Szeged, Csongrád megye, 6720
Peru3 sites
Instituto Nacional de Enfermedades Neoplasicas ( Site 1502)
Lima, 15038
Clinica Anglo Americana ( Site 1501)
Lima, 15073
Clinica Delgado ( Site 1503)
Lima, 15074
United Kingdom3 sites
Leeds Teaching Hospitals NHS Trust ( Site 1002)
Leeds, LS1 3EX
Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1003)
Liverpool, L12 2AP
Royal Manchester Children's Hospital ( Site 1005)
Manchester, M13 9WL
Lithuania2 sites
LSMUL Kauno Klinikos ( Site 0402)
Kaunas, 50161
Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0401)
Vilnius, 08406
Poland2 sites
Instytut Matki i Dziecka ( Site 0601)
Warsaw, Masovian Voivodeship, 01-211
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0602)
Warsaw, Masovian Voivodeship, 04-730
About this study
Official title: A Phase 4, Open-label, Single Arm Study to Evaluate the Safety and Tolerability of a Three-day Fosaprepitant Regimen Administered for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants Receiving Emetogenic Chemotherapy
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.
Read the detailed description
Upon completion of Cycle 1, participants were given the option to exit the study and be considered completed, or to continue on study therapy for up to 2 more (optional) 17-day cycles of chemotherapy where fosaprepitant was administered and additional safety data collected.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Fosaprepitant Dimeglumine, 5-HT3 antagonist, Dexamethasone
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosaprepitant DimeglumineDrug
Also called EMEND for injection®, MK-0517
Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).
5-HT3 antagonistDrug
All participants received an oral 5-hydroxytryptamine (serotonin; [5-HT]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care.
DexamethasoneDrug
Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Fosaprepitant Treatment | Experimental | Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine [5-HT3]) receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen. Receives: Drug: Fosaprepitant Dimeglumine; Drug: 5-HT3 antagonist; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who experience one or more AE(s) is presented.
Measured: Up to 17 days
Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who discontinue study treatment due to an AE is presented.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start9 Sep 2019
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
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 Chemotherapy-induced Nausea and VomitingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 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
- NCT04054193
- Sponsor's protocol ID
- 0517-045
- Other IDs
- MK-0517-045, 2018-004844-43, 2018
- Status last verified
- Jan 2025
- First submitted
- 9 Aug 2019
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Garcia Leon JL, DiCristina C, Yao R, Afzal AS. Safety and Tolerability of a 3-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients: Results of an Open-Label, Single-Arm Phase 4 Trial. Pediatr Hematol Oncol. 2025 Mar;42(2):79-91. doi: 10.1080/08880018.2024.2437047. Epub 2024 Dec 10.
PubMed 39655741
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-label, Single Arm Study to Evaluate the Safety and Tolerability of a Three-day Fosaprepitant Regimen Administered for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants Receiving Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT04054193
- Acronym / sponsor ID
- 0517-045
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Posted 23 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.
Detailed description
Upon completion of Cycle 1, participants were given the option to exit the study and be considered completed, or to continue on study therapy for up to 2 more (optional) 17-day cycles of chemotherapy where fosaprepitant was administered and additional safety data collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fosaprepitant Treatment | Experimental | Drug: Fosaprepitant Dimeglumine, Drug: 5-HT3 antagonist, Drug: DexamethasoneParticipants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine [5-HT3]) receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Is receiving a moderately or highly emetogenic chemotherapy agent/regimen or a chemotherapy agent/regimen not previously tolerated due to vomiting
- Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age)
- Has a pre-existing functional central venous catheter available for study treatment administration
- Is fosaprepitant naïve
- Has a predicted life expectancy ≥3 months
Key exclusion criteria (11 listed)
- Will receive stem cell rescue therapy in conjunction with a study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant
- Is currently a user of any recreational or illicit drugs or has current evidence of drug or alcohol abuse or dependence as determined by the investigator
- Is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry
- Is pregnant or breast feeding
- Is allergic to fosaprepitant, aprepitant, or prescribed 5-HT3 antagonist
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 |
|---|---|---|
| Fosaprepitant DimeglumineAlso: EMEND for injection®, MK-0517Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age). | Drug | Fosaprepitant Treatment |
| 5-HT3 antagonistAll participants received an oral 5-hydroxytryptamine (serotonin; [5-HT]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care. | Drug | Fosaprepitant Treatment |
| DexamethasoneParticipants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care. | Drug | Fosaprepitant Treatment |
Primary outcome
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs)
Time frame: Up to 17 days
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who experience one or more AE(s) is presented.
Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE)
Time frame: Up to 3 days
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who discontinue study treatment due to an AE is presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39655741Garcia Leon JL, DiCristina C, Yao R, Afzal AS. Safety and Tolerability of a 3-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients: Results of an Open-Label, Single-Arm Phase 4 Trial. Pediatr Hematol Oncol. 2025 Mar;42(2):79-91. doi: 10.1080/08880018.2024.2437047. Epub 2024 Dec 10.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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
26 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fosaprepitant Dimeglumine, 5-HT3 antagonist and Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC at 26 sites in 9 countries.
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 8 inclusion and 11 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Russia, Greece, Hungary, Peru and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 23 Sep 2021). 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?
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs) (time frame: Up to 17 days). The study lists 2 primary outcomes in all. 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 NCT04054193, 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 16 Jan 2025.