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    Clinical Trial Results:
    eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

    Summary
    EudraCT number
    		 2020-004035-24
    Trial protocol
    		 FR   BE   DE   FI   AT   HU   GR   IT   ES  
    Global end of trial date
    26 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2025
    First version publication date
    12 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I3Y-MC-JPCW
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04752332
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Clinical Trial Registry Office, Eli Lilly, 1 08772854559,, EU_Lilly_Clinical_Trials@lilly.com
    Scientific contact
    Clinical Trial Registry Office, Eli Lilly, 1 877CTLilly, EU_Lilly_Clinical_Trials@lilly.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of abemaciclib plus physician’s choice ET versus placebo plus physician’s choice ET in the study population.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Brazil: 6
    Country: Number of subjects enrolled
    China: 27
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Japan: 10
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    111
    EEA total number of subjects
    29
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    98
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was terminated early due to inability to enroll study participants. Data was not collected after termination and outcome measures were not assessed.

    Pre-assignment
    Screening details
    		 Completers were defined as participants who received abemaciclib and were allowed to stay on treatment in the study. Participants receiving placebo discontinued after the study was terminated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 150 mg Abemaciclib + Endocrine Therapy (ET)
    Arm description
    		 Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abemaciclib
    Investigational medicinal product code
    Other name
    LY2835219
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally.

    Arm title
    		 Placebo + ET
    Arm description
    		 Participants received placebo administered BID orally along with standard adjuvant ET.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally.

    Number of subjects in period 1
    		150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Started
    55
    56
    Received At Least One Dose of Study Drug
    55
    56
    Completed
    25
    0
    Not completed
    30
    56
         Consent withdrawn by subject
    11
    3
         Physician decision
    2
    1
         Disease Relapse
    1
    -
         Adverse event, non-fatal
    3
    1
         Non-compliance With Study Drug
    2
    -
         Study Terminated by IRB/ERB
    -
    2
         Study Terminated by Sponsor
    10
    48
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    150 mg Abemaciclib + Endocrine Therapy (ET)
    Reporting group description
    		 Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).

    Reporting group title
    Placebo + ET
    Reporting group description
    		 Participants received placebo administered BID orally along with standard adjuvant ET.

    Reporting group values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET Total
    Number of subjects
    		 55 56 111
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.60 ( 11.76 ) 49.70 ( 11.17 ) -
    Gender categorical
    Units: Subjects
        Female
    		 54 56 110
        Male
    		 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 9 12 21
        Not Hispanic or Latino
    		 44 41 85
        Unknown or Not Reported
    		 2 3 5
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 26 23 49
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 2 3
        White
    		 27 29 56
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 1 2
    Region of Enrollment
    Units: Subjects
        Argentina
    		 4 5 9
        Australia
    		 1 1 2
        Austria
    		 0 1 1
        Belgium
    		 2 2 4
        Brazil
    		 3 3 6
        China
    		 12 15 27
        France
    		 2 0 2
        Germany
    		 2 1 3
        Greece
    		 4 4 8
        Hungary
    		 1 0 1
        Israel
    		 1 0 1
        Italy
    		 1 1 2
        Japan
    		 7 3 10
        Mexico
    		 1 1 2
        South Korea
    		 4 2 6
        Spain
    		 3 5 8
        Switzerland
    		 0 2 2
        Taiwan
    		 1 3 4
        United Kingdom
    		 1 4 5
        United States
    		 5 3 8

    End points

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    End points reporting groups
    Reporting group title
    150 mg Abemaciclib + Endocrine Therapy (ET)
    Reporting group description
    		 Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).

    Reporting group title
    Placebo + ET
    Reporting group description
    		 Participants received placebo administered BID orally along with standard adjuvant ET.

    Primary: Invasive Disease Free Survival (IDFS)

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    End point title
    		 Invasive Disease Free Survival (IDFS) [1]
    End point description
    IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
    End point type
    Primary
    End point timeframe
    Randomization to Recurrence or Death from Any Cause (up to 890 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: Study was terminated early. Data was not collected after termination and outcome measures were not assessed.
    End point values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Months
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Study was terminated early, and no outcome measures were assessed.
    [3] - Study was terminated early, and no outcome measures were assessed.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from randomization until death from any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
    End point type
    Secondary
    End point timeframe
    Randomization to Death from Any Cause (up to 890 days)
    End point values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Months
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [4] - Study was terminated early, and no outcome measures were assessed.
    [5] - Study was terminated early, and no outcome measures were assessed.
    No statistical analyses for this end point

    Secondary: Distant Relapse-Free Survival (DRFS)

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    End point title
    		 Distant Relapse-Free Survival (DRFS)
    End point description
    DRFS is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
    End point type
    Secondary
    End point timeframe
    Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)
    End point values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Months
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [6] - Study was terminated early, and no outcome measures were assessed.
    [7] - Study was terminated early, and no outcome measures were assessed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence

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    End point title
    		 Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence
    End point description
    Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
    End point type
    Secondary
    End point timeframe
    Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
    End point values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Percentage of Participants
        number (not applicable)
    Notes
    [8] - Study was terminated early, and no outcome measures were assessed.
    [9] - Study was terminated early, and no outcome measures were assessed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score

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    End point title
    		 Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
    End point description
    The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation will be applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
    End point type
    Secondary
    End point timeframe
    Cycle 1 up to 390 days
    End point values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Score on a scale
        arithmetic mean (standard error)
    ( )
    ( )
    Notes
    [10] - Study was terminated early, and no outcome measures were assessed.
    [11] - Study was terminated early, and no outcome measures were assessed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score

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    End point title
    		 Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
    End point description
    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which are anchored on a scale of 0 to 1 with a higher score representing better health status. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
    End point type
    Secondary
    End point timeframe
    Cycle 1 up to 390 days
    End point values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: Score on a scale
        arithmetic mean (standard error)
    ( )
    ( )
    Notes
    [12] - Study was terminated early, and no outcome measures were assessed.
    [13] - Study was terminated early, and no outcome measures were assessed.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib

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    End point title
    		 Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
    End point description
    Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycles 1-3 (Cycle = 28 days)
    End point values
    		 150 mg Abemaciclib + Endocrine Therapy (ET) Placebo + ET
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: microgram(s)/millilitre
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [14] - Study was terminated early, and no outcome measures were assessed.
    [15] - Study was terminated early, and no outcome measures were assessed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up To 890 Days
    Adverse event reporting additional description
    All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding regimen received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    150 mg Abemaciclib + ET
    Reporting group description
    		 Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.

    Reporting group title
    Placebo + ET
    Reporting group description
    		 Participants received placebo administered BID orally along with standard adjuvant ET.

    Serious adverse events
    		 150 mg Abemaciclib + ET Placebo + ET
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 55 (10.91%)
    2 / 56 (3.57%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    uterine leiomyoma
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed [1]
    0 / 54 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    radius fracture
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    neutropenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pulmonary embolism
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 56 (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
    covid-19
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anal abscess
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 150 mg Abemaciclib + ET Placebo + ET
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 55 (96.36%)
    40 / 56 (71.43%)
    Investigations
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0
    blood creatinine increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    10 / 55 (18.18%)
    0 / 56 (0.00%)
         occurrences all number
    13
    0
    Vascular disorders
    hot flush
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 55 (0.00%)
    8 / 56 (14.29%)
         occurrences all number
    0
    8
    Cardiac disorders
    palpitations
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    5 / 55 (9.09%)
    6 / 56 (10.71%)
         occurrences all number
    7
    6
    dizziness
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    7 / 55 (12.73%)
    5 / 56 (8.93%)
         occurrences all number
    8
    8
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    13 / 55 (23.64%)
    1 / 56 (1.79%)
         occurrences all number
    24
    1
    lymphopenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    5 / 55 (9.09%)
    0 / 56 (0.00%)
         occurrences all number
    8
    0
    leukopenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    17 / 55 (30.91%)
    3 / 56 (5.36%)
         occurrences all number
    31
    3
    neutropenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    28 / 55 (50.91%)
    4 / 56 (7.14%)
         occurrences all number
    63
    5
    thrombocytopenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    12 / 55 (21.82%)
    0 / 56 (0.00%)
         occurrences all number
    14
    0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    16 / 55 (29.09%)
    6 / 56 (10.71%)
         occurrences all number
    24
    7
    oedema peripheral
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    3 / 56 (5.36%)
         occurrences all number
    3
    3
    pyrexia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    4 / 55 (7.27%)
    0 / 56 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    12 / 55 (21.82%)
    6 / 56 (10.71%)
         occurrences all number
    18
    11
    abdominal distension
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 56 (5.36%)
         occurrences all number
    1
    3
    diarrhoea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    44 / 55 (80.00%)
    5 / 56 (8.93%)
         occurrences all number
    97
    7
    constipation
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    6 / 56 (10.71%)
         occurrences all number
    4
    9
    nausea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    17 / 55 (30.91%)
    8 / 56 (14.29%)
         occurrences all number
    24
    8
    stomatitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    5 / 55 (9.09%)
    0 / 56 (0.00%)
         occurrences all number
    5
    0
    vomiting
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    11 / 55 (20.00%)
    1 / 56 (1.79%)
         occurrences all number
    12
    1
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    4 / 55 (7.27%)
    2 / 56 (3.57%)
         occurrences all number
    4
    2
    Skin and subcutaneous tissue disorders
    pruritus
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    6 / 55 (10.91%)
    2 / 56 (3.57%)
         occurrences all number
    9
    2
    rash
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 56 (0.00%)
         occurrences all number
    7
    0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    4 / 55 (7.27%)
    1 / 56 (1.79%)
         occurrences all number
    4
    1
    arthralgia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    6 / 55 (10.91%)
    11 / 56 (19.64%)
         occurrences all number
    7
    13
    myalgia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 56 (1.79%)
         occurrences all number
    3
    1
    pain in extremity
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 55 (1.82%)
    4 / 56 (7.14%)
         occurrences all number
    2
    4
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    13 / 55 (23.64%)
    8 / 56 (14.29%)
         occurrences all number
    13
    9
    nasopharyngitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    4 / 55 (7.27%)
    1 / 56 (1.79%)
         occurrences all number
    4
    2
    upper respiratory tract infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 56 (1.79%)
         occurrences all number
    3
    2
    urinary tract infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 55 (5.45%)
    2 / 56 (3.57%)
         occurrences all number
    4
    2
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    4 / 55 (7.27%)
    0 / 56 (0.00%)
         occurrences all number
    7
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2021
    - Updated inclusion and exclusion criteria for clarity; - Corrections made in Risk Assessment table and CYP3A guidance text.
    20 May 2021
    - Modified definition of high risk with regard to histologic grade, restricting it to participants with histologic Grade 3 disease; - Updated inclusion criteria to provide more clarity on related treatment discontinuation.
    14 Feb 2022
    - Added details about participant enrolment and unblinding; - Updated objectives section for this amendment; - Updated end of study and study completion definitions; - Specified that study will not evaluate compliance/PK assessments and safety data capture instructions.

    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.
    The study was terminated early due to inability to enroll study participants.
    For support, Contact us.
    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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