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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2018-004844-43
    Trial protocol
    		 GB   LT   PL   HU   NL   GR  
    Global end of trial date
    11 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Aug 2021
    First version publication date
    19 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0517-045
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04054193
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Sep 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Greece: 15
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Lithuania: 11
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    Peru: 19
    Worldwide total number of subjects
    103
    EEA total number of subjects
    53
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    15
    Children (2-11 years)
    57
    Adolescents (12-17 years)
    31
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants were recruited at 25 study sites in 9 countries. All participants were enrolled for Cycle 1 on which the primary objective was based.

    Pre-assignment
    Screening details
    		 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) cycles (3 days of treatment + 14 days of follow-up per cycle) of chemotherapy where fosarepitant was administered and additional safety data collected.

    Period 1
    Period 1 title
    Cycle 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fosarepitant Cycle 1
    Arm description
    		 Participants received fosarepitant dimeglumine once daily (QD) for 3 days during Cycle 1 and were followed for 14 days. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fosaprepitant dimeglumine
    Investigational medicinal product code
    Other name
    MK-0517
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants 6 months to <12 years of age received fosarepitant dimeglumine 3.0 mg/kg on Day 1 and 2.0 mg/kg on Days 2 and 3. Participants 12 to 17 years of age received fosarepitant dimeglumine 115 mg on Day 1 and 80 mg on Days 2 and 3.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received optional dexamethasone at the investigator's discretion according to product label or standard of care.

    Investigational medicinal product name
    5-HT3 Antagonist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All participants received a 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.

    Number of subjects in period 1
    		Fosarepitant Cycle 1
    Started
    103
    Treated (≥1 dose)
    100
    Completed
    98
    Not completed
    5
         Allocated but not treated
    3
         Physician decision
    1
         Consent withdrawn by parent/guardian
    1
    Period 2
    Period 2 title
    Cycles 2-3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fosarepitant Cycles 2-3
    Arm description
    		 Participants received fosarepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during Cycles 2-3. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy, of each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fosarepitant
    Investigational medicinal product code
    Other name
    MK-0517
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants 6 months to <12 years of age received fosarepitant 3.0 mg/kg on Day 1 and 2.0 mg/kg on Days 2 and 3. Participants 12 to 17 years of age received fosarepitant 115 mg on Day 1 and 80 mg on Days 2 and 3.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received optional dexamethasone at the investigator's discretion according to product label or standard of care.

    Investigational medicinal product name
    5-HT3 Antagonist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All participants received a 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.

    Number of subjects in period 2 [1]
    		Fosarepitant Cycles 2-3
    Started
    69
    Completed
    48
    Not completed
    21
         Physician decision
    2
         Consent withdrawn by parent/guardian
    2
         Various reasons
    17
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Upon completion of Cycle 1 (upon which the study objectives are based), participants had the option to exit the study and be considered completed, or to continue on for up to 2 additional treatment cycles.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fosarepitant Cycle 1
    Reporting group description
    		 Participants received fosarepitant dimeglumine once daily (QD) for 3 days during Cycle 1 and were followed for 14 days. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy.

    Reporting group values
    		 Fosarepitant Cycle 1 Total
    Number of subjects
    		 103 103
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days - 23 months)
    		 15 15
        Children (2 to 11 years)
    		 57 57
        Adolescents (12 to 17 years)
    		 31 31
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.7 ( 5.0 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 50 50
        Male
    		 53 53
    Race
    Units: Subjects
        American Indian Or Alaska Native
    		 14 14
        Black Or African American
    		 2 2
        Multiple
    		 6 6
        White
    		 81 81
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    		 22 22
        Not Hispanic Or Latino
    		 77 77
        Not Reported
    		 1 1
        Unknown
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Fosarepitant Cycle 1
    Reporting group description
    		 Participants received fosarepitant dimeglumine once daily (QD) for 3 days during Cycle 1 and were followed for 14 days. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy.
    Reporting group title
    Fosarepitant Cycles 2-3
    Reporting group description
    		 Participants received fosarepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during Cycles 2-3. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy, of each cycle.

    Primary: Percentage of Participants Who Experienced One or More Adverse Events (AEs) During Cycle 1

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    End point title
    		 Percentage of Participants Who Experienced One or More Adverse Events (AEs) During Cycle 1 [1]
    End point description
    An adverse event (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 who experience one or more AE(s) during Cycle 1 is presented. The analysis population consists of all allocated participants who received ≥1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to 22 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 Fosarepitant Cycle 1
    Number of subjects analysed
    100
    Units: Percentage of Participants
        number (not applicable)
    80.0
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) During Cycle 1

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    End point title
    		 Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) During Cycle 1 [2]
    End point description
    An adverse event (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 who discontinue study treatment due to an AE during Cycle 1 is presented. The analysis population consists of all allocated participants who received ≥1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to 3 days
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 Fosarepitant Cycle 1
    Number of subjects analysed
    100
    Units: Percentage of Participants
        number (not applicable)
    2.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 3.5 months
    Adverse event reporting additional description
    All allocated participants who received ≥1 dose of study intervention are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Fosarepitant Cycle 1
    Reporting group description
    		 Participants received fosarepitant dimeglumine once daily (QD) for 3 days during Cycle 1 and were followed for 14 days. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy.

    Reporting group title
    Fosarepitant Cycles 2-3
    Reporting group description
    		 Participants received fosarepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during Cycles 2-3. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy, of each cycle.

    Serious adverse events
    		 Fosarepitant Cycle 1 Fosarepitant Cycles 2-3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 100 (30.00%)
    27 / 69 (39.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Coordination abnormal
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 100 (1.00%)
    4 / 69 (5.80%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    17 / 100 (17.00%)
    15 / 69 (21.74%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 69 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelosuppression
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 69 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 100 (0.00%)
    3 / 69 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematotoxicity
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 100 (2.00%)
    2 / 69 (2.90%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Stevens-Johnson syndrome
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 69 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungaemia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fosarepitant Cycle 1 Fosarepitant Cycles 2-3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 100 (64.00%)
    27 / 69 (39.13%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    14 / 100 (14.00%)
    2 / 69 (2.90%)
         occurrences all number
    14
    2
    Platelet count decreased
         subjects affected / exposed
    9 / 100 (9.00%)
    4 / 69 (5.80%)
         occurrences all number
    9
    4
    White blood cell count decreased
         subjects affected / exposed
    7 / 100 (7.00%)
    1 / 69 (1.45%)
         occurrences all number
    8
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    24 / 100 (24.00%)
    7 / 69 (10.14%)
         occurrences all number
    28
    8
    Haematotoxicity
         subjects affected / exposed
    9 / 100 (9.00%)
    10 / 69 (14.49%)
         occurrences all number
    9
    15
    Neutropenia
         subjects affected / exposed
    15 / 100 (15.00%)
    4 / 69 (5.80%)
         occurrences all number
    16
    4
    Thrombocytopenia
         subjects affected / exposed
    11 / 100 (11.00%)
    3 / 69 (4.35%)
         occurrences all number
    11
    3
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 100 (6.00%)
    3 / 69 (4.35%)
         occurrences all number
    6
    3
    Nausea
         subjects affected / exposed
    24 / 100 (24.00%)
    8 / 69 (11.59%)
         occurrences all number
    25
    9
    Vomiting
         subjects affected / exposed
    16 / 100 (16.00%)
    8 / 69 (11.59%)
         occurrences all number
    18
    13
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 100 (6.00%)
    0 / 69 (0.00%)
         occurrences all number
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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