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    Clinical Trial Results:
    An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability when Receiving Abemaciclib for Patients with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

    Summary
    EudraCT number
    		 2018-001853-28
    Trial protocol
    		 ES   BE  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    02 Aug 2020
    First version publication date
    02 Aug 2020
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    I3Y-MC-JPCP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03703466
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17041
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    Interim
    Date of interim/final analysis
    29 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jul 2019
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.
    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
    28 Nov 2018
    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
    Turkey: 18
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Australia: 31
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Russian Federation: 3
    Worldwide total number of subjects
    72
    EEA total number of subjects
    20
    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)
    53
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 Study completers are participants who completed 3 cycles (28 days cycle)

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 200 mg Abemaciclib with a Meal
    Arm description
    		 200 mg abemaciclib given twice a day (BID) orally with a meal.
    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
    		 200 mg Abemaciclib without a Meal
    Arm description
    		 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
    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
    		 200 mg Abemaciclib without Regard to Food
    Arm description
    		 200 mg abemaciclib given twice a day (BID) orally without regard for food.
    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.

    Number of subjects in period 1
    		200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Started
    24
    24
    24
    Received at least one dose of study drug
    24
    23
    24
    Completed
    20
    18
    22
    Not completed
    4
    6
    2
         Adverse event, serious fatal
    2
    1
    -
         Consent withdrawn by subject
    -
    3
    -
         Completed < 3 Cycles As Of Data Cut-Off
    1
    2
    2
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    200 mg Abemaciclib with a Meal
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally with a meal.

    Reporting group title
    200 mg Abemaciclib without a Meal
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.

    Reporting group title
    200 mg Abemaciclib without Regard to Food
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally without regard for food.

    Reporting group values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food Total
    Number of subjects
    		 24 24 24 72
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.2 ± 11.6 56.9 ± 11.1 57.6 ± 8.3 -
    Gender categorical
    Units: Subjects
        Female
    		 23 24 24 71
        Male
    		 1 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 1 1
        Not Hispanic or Latino
    		 24 19 20 63
        Unknown or Not Reported
    		 0 5 3 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 22 24 24 70
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Turkey
    		 6 6 6 18
        Belgium
    		 0 1 0 1
        Australia
    		 11 10 10 31
        Spain
    		 6 6 7 19
        Russia
    		 1 1 1 3

    End points

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    End points reporting groups
    Reporting group title
    200 mg Abemaciclib with a Meal
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally with a meal.

    Reporting group title
    200 mg Abemaciclib without a Meal
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.

    Reporting group title
    200 mg Abemaciclib without Regard to Food
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally without regard for food.

    Primary: Percentage of Participants with Severe Diarrhea (≥ Grade 3)

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    End point title
    		 Percentage of Participants with Severe Diarrhea (≥ Grade 3) [1]
    End point description
    Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL). Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Cycle 3 (28 Days Cycle)
    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, no statistical analyses (comparison analysis) were specified.
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24
    23
    24
    Units: percentage of participants
        number (not applicable)
    4.2
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants with Prolonged Grade 2 Diarrhea

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    End point title
    		 Percentage of Participants with Prolonged Grade 2 Diarrhea [2]
    End point description
    Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline. Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Cycle 3 (28 Days Cycle)
    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, no statistical analyses (comparison analysis) were specified.
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24
    23
    24
    Units: percentage of participants
        number (not applicable)
    8.3
    17.4
    20.8
    No statistical analyses for this end point

    Primary: Percentage of Participants with Dose Reductions Due to Diarrhea

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    End point title
    		 Percentage of Participants with Dose Reductions Due to Diarrhea [3]
    End point description
    Percentage of participants with dose reductions due to diarrhea during first 3 cycles. Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Cycle 3 (28 Days Cycle)
    Notes
    [3] - 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, no statistical analyses (comparison analysis) were specified.
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24
    23
    24
    Units: percentage of participants
        number (not applicable)
    16.7
    8.7
    12.5
    No statistical analyses for this end point

    Primary: Percentage of Participants with Dose Interruptions Due to Diarrhea

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    End point title
    		 Percentage of Participants with Dose Interruptions Due to Diarrhea [4]
    End point description
    Percentage of participants with dose interruptions due to diarrhea during first 3 cycles. Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Cycle 3 (28 Days Cycle)
    Notes
    [4] - 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, no statistical analyses (comparison analysis) were specified.
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24
    23
    24
    Units: percentage of participants
        number (not applicable)
    16.7
    4.3
    8.3
    No statistical analyses for this end point

    Primary: Percentage of Participants who Discontinue Treatment due to Diarrhea

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    End point title
    		 Percentage of Participants who Discontinue Treatment due to Diarrhea [5]
    End point description
    Percentage of participants who discontinue treatment due to diarrhea Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Cycle 3 (28 Days Cycle)
    Notes
    [5] - 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, no statistical analyses (comparison analysis) were specified.
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24
    23
    24
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants Utilizing Antidiarrheals

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    End point title
    		 Percentage of Participants Utilizing Antidiarrheals [6]
    End point description
    Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles. Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Cycle 3 (28 Days Cycle)
    Notes
    [6] - 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, no statistical analyses (comparison analysis) were specified.
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24
    23
    24
    Units: percentage of participants
        number (not applicable)
    95.8
    91.3
    95.8
    No statistical analyses for this end point

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

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    End point title
    		 Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
    End point description
    PK: Mean steady state exposure of abemaciclib. Analysis Population Description: All participants who received at least one dose of study drug who had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Day 1, Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24 [7]
    21 [8]
    21 [9]
    Units: nanogram/milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1: Day 15
    305 ± 198
    369 ± 64
    356 ± 75
        Cycle 2: Day 1
    320 ± 91
    280 ± 99
    190 ± 284
        Cycle 2: Day 15
    77.4 ± 731
    345 ± 51
    223 ± 250
        Cycle 3: Day 1
    135 ± 896
    330 ± 54
    85.4 ± 498
    Notes
    [7] - Cycle 1:Day 15 n=23, Cycle 2 Day 1 n=15, Cycle 2: Day15 n=14 and Cycle 3: Day 1 n=10.
    [8] - Cycle 1:Day 15 n=16, Cycle 2 Day 1 n=12, Cycle 2: Day15 n=13 and Cycle 3: Day 1 n=13.
    [9] - Cycle 1:Day 15 n=21, Cycle 2 Day 1 n=18, Cycle 2: Day15 n=15 and Cycle 3: Day 1 n=14.
    No statistical analyses for this end point

    Secondary: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567

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    End point title
    		 PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
    End point description
    PK: Mean steady state exposure of abemaciclib metabolite LSN2839567. Analysis Population Description: All participants who received at least one dose of study drug who had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Day 1, Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24 [10]
    21 [11]
    21 [12]
    Units: nanogram/milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 15
    139 ± 109
    129 ± 48
    159 ± 61
        Cycle 2 Day 1
    125 ± 62
    109 ± 84
    96.3 ± 127
        Cycle 2 Day 15
    50.4 ± 276
    121 ± 45
    112 ± 79
        Cycle 3 Day 1
    89.4 ± 110
    125 ± 48
    61.7 ± 122
    Notes
    [10] - Cycle 1:Day 15 n=23, Cycle 2 Day 1 n=15, Cycle 2: Day15 n=14 and Cycle 3: Day 1 n=10.
    [11] - Cycle 1:Day 15 n=16, Cycle 2 Day 1 n=12, Cycle 2: Day15 n=13 and Cycle 3: Day 1 n=13.
    [12] - Cycle 1:Day 15 n=21, Cycle 2 Day 1 n=18, Cycle 2: Day15 n=15 and Cycle 3: Day 1 n=14.
    No statistical analyses for this end point

    Secondary: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726

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    End point title
    		 PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
    End point description
    PK: Mean steady state exposure of abemaciclib metabolite LSN3106726. Analysis Population Description: All participants who received at least one dose of study drug who had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Day 1, Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
    End point values
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Number of subjects analysed
    24 [13]
    21 [14]
    21 [15]
    Units: nanogram/milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 15
    231 ± 120
    242 ± 38
    287 ± 63
        Cycle 2 Day 1
    230 ± 59
    210 ± 57
    152 ± 222
        Cycle 2 Day 15
    80.5 ± 377
    221 ± 31
    182 ± 112
        Cycle 3 Day 1
    146 ± 174
    223 ± 33
    107 ± 172
    Notes
    [13] - Cycle 1:Day 15 n=23, Cycle 2 Day 1 n=15, Cycle 2: Day15 n=14 and Cycle 3: Day 1 n=10.
    [14] - Cycle 1:Day 15 n=16, Cycle 2 Day 1 n=12, Cycle 2: Day15 n=13 and Cycle 3: Day 1 n=13.
    [15] - Cycle 1:Day 15 n=21, Cycle 2 Day 1 n=18, Cycle 2: Day15 n=15 and Cycle 3: Day 1 n=14.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 7 Months
    Adverse event reporting additional description
    All participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    200 mg Abemaciclib with a Meal
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally with a meal.

    Reporting group title
    200 mg Abemaciclib without a Meal
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.

    Reporting group title
    200 mg Abemaciclib without Regard to Food
    Reporting group description
    		 200 mg abemaciclib given twice a day (BID) orally without regard for food.

    Serious adverse events
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 24 (12.50%)
    5 / 23 (21.74%)
    6 / 24 (25.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    thrombophlebitis superficial
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    guillain-barre syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 23 (13.04%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholangitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hepatic function abnormal
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Renal and urinary disorders
    renal failure
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 200 mg Abemaciclib with a Meal 200 mg Abemaciclib without a Meal 200 mg Abemaciclib without Regard to Food
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
    23 / 23 (100.00%)
    24 / 24 (100.00%)
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 24 (16.67%)
    1 / 23 (4.35%)
    4 / 24 (16.67%)
         occurrences all number
    7
    1
    6
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 24 (20.83%)
    1 / 23 (4.35%)
    3 / 24 (12.50%)
         occurrences all number
    10
    1
    4
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    3 / 24 (12.50%)
         occurrences all number
    4
    1
    6
    blood bilirubin increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    1
    blood creatinine increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 24 (12.50%)
    5 / 23 (21.74%)
    3 / 24 (12.50%)
         occurrences all number
    4
    7
    5
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 24 (12.50%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
         occurrences all number
    4
    2
    2
    lymphocyte count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 24 (20.83%)
    2 / 23 (8.70%)
    4 / 24 (16.67%)
         occurrences all number
    9
    2
    10
    neutrophil count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 24 (25.00%)
    5 / 23 (21.74%)
    7 / 24 (29.17%)
         occurrences all number
    21
    8
    24
    platelet count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    10 / 24 (41.67%)
    4 / 23 (17.39%)
    5 / 24 (20.83%)
         occurrences all number
    22
    9
    12
    weight decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    4 / 23 (17.39%)
    3 / 24 (12.50%)
         occurrences all number
    2
    5
    3
    white blood cell count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 24 (33.33%)
    7 / 23 (30.43%)
    7 / 24 (29.17%)
         occurrences all number
    20
    18
    27
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 24 (16.67%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
         occurrences all number
    5
    2
    1
    dysgeusia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    2
    0
    1
    headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 24 (16.67%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
         occurrences all number
    4
    2
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    14 / 24 (58.33%)
    9 / 23 (39.13%)
    9 / 24 (37.50%)
         occurrences all number
    23
    12
    24
    lymphopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    1 / 24 (4.17%)
         occurrences all number
    3
    3
    2
    neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 24 (25.00%)
    8 / 23 (34.78%)
    9 / 24 (37.50%)
         occurrences all number
    15
    17
    22
    thrombocytopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
         occurrences all number
    1
    2
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 24 (20.83%)
    5 / 23 (21.74%)
    4 / 24 (16.67%)
         occurrences all number
    8
    11
    11
    fatigue
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    10 / 24 (41.67%)
    3 / 23 (13.04%)
    10 / 24 (41.67%)
         occurrences all number
    11
    3
    17
    mucosal inflammation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 23 (4.35%)
    4 / 24 (16.67%)
         occurrences all number
    3
    1
    5
    oedema peripheral
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    1
    pyrexia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    Eye disorders
    lacrimation increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    2 / 24 (8.33%)
         occurrences all number
    0
    1
    5
    vision blurred
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    6
    Gastrointestinal disorders
    abdominal distension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
         occurrences all number
    2
    2
    4
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    9 / 24 (37.50%)
    3 / 23 (13.04%)
    5 / 24 (20.83%)
         occurrences all number
    10
    4
    7
    abdominal pain upper
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
         occurrences all number
    3
    3
    4
    constipation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    1
    0
    2
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    21 / 24 (87.50%)
    22 / 23 (95.65%)
    22 / 24 (91.67%)
         occurrences all number
    167
    173
    175
    dyspepsia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    3 / 24 (12.50%)
         occurrences all number
    0
    1
    10
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    3
    1
    0
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    14 / 24 (58.33%)
    11 / 23 (47.83%)
    11 / 24 (45.83%)
         occurrences all number
    15
    19
    16
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    10 / 24 (41.67%)
    10 / 23 (43.48%)
    4 / 24 (16.67%)
         occurrences all number
    21
    18
    6
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    4 / 23 (17.39%)
    1 / 24 (4.17%)
         occurrences all number
    2
    5
    1
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    2
    1
    0
    dry skin
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    1 / 24 (4.17%)
         occurrences all number
    3
    1
    1
    pruritus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    3 / 23 (13.04%)
    2 / 24 (8.33%)
         occurrences all number
    1
    3
    2
    rash
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 24 (16.67%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
         occurrences all number
    4
    3
    2
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
         occurrences all number
    1
    2
    1
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    3
    0
    3
    musculoskeletal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    3 / 24 (12.50%)
         occurrences all number
    0
    1
    3
    Infections and infestations
    respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    2 / 24 (8.33%)
         occurrences all number
    2
    1
    2
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 24 (29.17%)
    8 / 23 (34.78%)
    9 / 24 (37.50%)
         occurrences all number
    8
    11
    11
    hypoalbuminaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 24 (8.33%)
    3 / 23 (13.04%)
    0 / 24 (0.00%)
         occurrences all number
    4
    6
    0
    hypokalaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 24 (4.17%)
    5 / 23 (21.74%)
    0 / 24 (0.00%)
         occurrences all number
    1
    8
    0
    hyponatraemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jan 2019
    Amendment B: Revised inclusion criteria for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values. Dose adjustment rules modified. Incorporated safety monitoring language for hepatic conditions, renal function and venous thromboembolic events (VTEs). Incorporated cystatin C clinical chemistry laboratory test.
    18 Feb 2020
    Amendment D: Revised dose modification and delay guidance for interstitial lung disease (ILD)/pneumonitis events to align with the updated Investigator’s Brochure. Revised guidance and listing of moderate inducers and additional strong inhibitors of CYP3A.

    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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