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Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Fosaprepitant Dimeglumine
5-HT3 antagonist
Dexamethasone
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Phoenix Childrens Hospital ( Site 1101)
  • Southern California Permanente Medical Group ( Site 1104)
  • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1106)
  • Children's Hospitals and Clinics of Minnesota ( Site 1109)
  • St. Jude Children's Research Hospital ( Site 1111)
  • Athens Childrens Hospital Aglaia Kyriakou ( Site 0101)
  • University of Athens - Aghia Sophia Childrens Hospital ( Site 0102)
  • University General Hospital of Thessaloniki "AHEPA" ( Site 0103)
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0203)
  • Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0201)
  • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0202)
  • LSMUL Kauno Klinikos ( Site 0402)
  • Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0401)
  • Prinses Maxima Centrum ( Site 0501)
  • Instituto Nacional de Enfermedades Neoplasicas ( Site 1502)
  • Clinica Anglo Americana ( Site 1501)
  • Clinica Delgado ( Site 1503)
  • Instytut Matki i Dziecka ( Site 0601)
  • Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0602)
  • Chelyabinsk Regional Children Clinical Hospital ( Site 0705)
  • Blokhin National Medical Oncology ( Site 0701)
  • Dmitry Rogachev National Research Center ( Site 0704)
  • Clinical Research Center of specialized types medical care-Oncology ( Site 0706)
  • Leeds Teaching Hospitals NHS Trust ( Site 1002)
  • Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1003)
  • Royal Manchester Children's Hospital ( Site 1005)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fosaprepitant Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2019
Last Updated
September 22, 2021
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04054193
Brief Title
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fosaprepitant Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant Dimeglumine
Other Intervention Name(s)
EMEND for injection®, MK-0517
Intervention Description
Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).
Intervention Type
Drug
Intervention Name(s)
5-HT3 antagonist
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.
Primary Outcome Measure Information:
Title
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs)
Description
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.
Time Frame
Up to 17 days
Title
Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE)
Description
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.
Time Frame
Up to 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Childrens Hospital ( Site 1101)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Southern California Permanente Medical Group ( Site 1104)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1106)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota ( Site 1109)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
St. Jude Children's Research Hospital ( Site 1111)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Athens Childrens Hospital Aglaia Kyriakou ( Site 0101)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University of Athens - Aghia Sophia Childrens Hospital ( Site 0102)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University General Hospital of Thessaloniki "AHEPA" ( Site 0103)
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0203)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0201)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0202)
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
LSMUL Kauno Klinikos ( Site 0402)
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0401)
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Prinses Maxima Centrum ( Site 0501)
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Facility Name
Instituto Nacional de Enfermedades Neoplasicas ( Site 1502)
City
Lima
ZIP/Postal Code
15038
Country
Peru
Facility Name
Clinica Anglo Americana ( Site 1501)
City
Lima
ZIP/Postal Code
15073
Country
Peru
Facility Name
Clinica Delgado ( Site 1503)
City
Lima
ZIP/Postal Code
15074
Country
Peru
Facility Name
Instytut Matki i Dziecka ( Site 0601)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0602)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Chelyabinsk Regional Children Clinical Hospital ( Site 0705)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Blokhin National Medical Oncology ( Site 0701)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Dmitry Rogachev National Research Center ( Site 0704)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Clinical Research Center of specialized types medical care-Oncology ( Site 0706)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Leeds Teaching Hospitals NHS Trust ( Site 1002)
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1003)
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital ( Site 1005)
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)

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