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    Clinical Trial Results:
    A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

    Summary
    EudraCT number
    		 2019-004833-18
    Trial protocol
    		 IT   FR  
    Global end of trial date
    20 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jul 2023
    First version publication date
    05 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MS200647_0020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04489940
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Healthcare KGaA, Darmstadt, Germany
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Center, Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Center,, Merck Healthcare KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.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
    08 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to evaluate bintrafusp alfa monotherapy in subjects with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2020
    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
    United States: 2
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Russian Federation: 4
    Worldwide total number of subjects
    11
    EEA total number of subjects
    5
    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)
    7
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 15 subjects were screened, of which 11 subjects received bintrafusp alfa monotherapy.

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

    Arms
    Arm title
    		 Bintrafusp alfa
    Arm description
    		 Subjects received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bintrafusp alfa
    Investigational medicinal product code
    M7824
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

    Number of subjects in period 1
    		Bintrafusp alfa
    Started
    11
    Completed
    1
    Not completed
    10
         Adverse event, serious fatal
    5
         Consent withdrawn by subject
    2
         Other
    2
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bintrafusp alfa
    Reporting group description
    		 Subjects received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

    Reporting group values
    		 Bintrafusp alfa Total
    Number of subjects
    		 11 11
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 59 ( 11.3 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 11 11
        Male
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 9 9
        Unknown or Not Reported
    		 2 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 9 9
        More than one race
    		 0 0
        Unknown or Not Reported
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Bintrafusp alfa
    Reporting group description
    		 Subjects received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

    Primary: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC)

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    End point title
    		 Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) [1]
    End point description
    The ORR was defined as the percentage of subjects with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by IRC. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.
    End point type
    Primary
    End point timeframe
    Time from first study intervention up to 321 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: No statistical and comparison analysis were performed in single arm for this endpoint.
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [2]
    Units: Percentage of subjects
    Notes
    [2] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) According to RECIST Version 1.1

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    End point title
    		 Duration of Response (DOR) According to RECIST Version 1.1
    End point description
    DOR was defined for subjects with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC.
    End point type
    Secondary
    End point timeframe
    From first documented objective response to PD or death due to any cause, assessed up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [3]
    Units: Percentage of subjects
    Notes
    [3] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Durable Response Rate (DRR) of at Least 6 Months Assessed by an Independent Review Committee (IRC)

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    End point title
    		 Durable Response Rate (DRR) of at Least 6 Months Assessed by an Independent Review Committee (IRC)
    End point description
    DRR was defined as the number of subjects having a DOR of at least 6 months, out of the total number of subjects.
    End point type
    Secondary
    End point timeframe
    Time from first study intervention up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [4]
    Units: Percentage of subjects
    Notes
    [4] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

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    End point title
    		 Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
    End point description
    DRR was defined as the number of subjects having a DOR of at least 6 months, out of the total number of subjects.
    End point type
    Secondary
    End point timeframe
    Time from first study intervention up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [5]
    Units: Percentage of subjects
    Notes
    [5] - As per changes in planned analysis, the endpoints related to efficacy were not 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 was defined as the time from first day of study treatment to death due to any cause. Subjects without documented death at the time of analysis are censored at the date of the last follow-up. OS was summarized by Kaplan-Meier (KM) methods.
    End point type
    Secondary
    End point timeframe
    Time from the first dose of study drug until occurrence of death due to any cause, assessed up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [6]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [6] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator

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    End point title
    		 Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator
    End point description
    The ORR was defined as the percentage of subjects with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.
    End point type
    Secondary
    End point timeframe
    Time from first study intervention up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [7]
    Units: Percentage of subjects
    Notes
    [7] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator

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    End point title
    		 Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator
    End point description
    DOR was defined for subjects with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by investigator.
    End point type
    Secondary
    End point timeframe
    From first documented objective response to PD or death due to any cause, assessed up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [8]
    Units: Percentage of subjects
    Notes
    [8] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) According to RECIST Version 1.1 Assessed by the IRC

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    End point title
    		 Progression-Free Survival (PFS) According to RECIST Version 1.1 Assessed by the IRC
    End point description
    PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the IRC.
    End point type
    Secondary
    End point timeframe
    Time from first study intervention up to until the first documentation of PD or death, assessed up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [9]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [9] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

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    End point title
    		 Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
    End point description
    PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator.
    End point type
    Secondary
    End point timeframe
    Time from first study intervention up to the first documentation of PD or death, assessed up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [10]
    Units: Percentage of subjects
        median (confidence interval 95%)
    ( to )
    Notes
    [10] - As per changes in planned analysis, the endpoints related to efficacy were not assessed.
    No statistical analyses for this end point

    Secondary: Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa

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    End point title
    		 Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa
    End point description
    Ceoi was the serum concentration observed immediately at the end of infusion. This was taken directly from the observed bintrafusp alfa concentration-time data.
    End point type
    Secondary
    End point timeframe
    Pre-dose, End of Infusion from Day 1 to 321
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [11]
    Units: microgram per milliliter (mcg/mL)
        geometric mean (geometric coefficient of variation)
    ( )
    Notes
    [11] - As per changes in planned analysis the endpoints related to pharmacokinetics were not assessed.
    No statistical analyses for this end point

    Secondary: Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa

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    End point title
    		 Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa
    End point description
    Ctrough was the serum concentration observed immediately before next dosing.
    End point type
    Secondary
    End point timeframe
    Pre-dose, End of Infusion from Day 1 to 321
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [12]
    Units: microgram per milliliter (mcg/mL)
        geometric mean (geometric coefficient of variation)
    ( )
    Notes
    [12] - As per changes in planned analysis, the endpoints related to pharmacokinetics were not assessed.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa

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    End point title
    		 Number of Subjects With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa
    End point description
    The detection of antibodies to bintrafusp alfa was performed using a validated ADA assay method with tiered testing of screening, confirmatory and titration.
    End point type
    Secondary
    End point timeframe
    Pre-dose, End of Infusion from Day 1 to 321
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    0 [13]
    Units: subjects
    Notes
    [13] - As per changes in planned analysis, the endpoints related to immunogenicity were not assessed.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, and Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, and Adverse Events of Special Interest (AESIs)
    End point description
    An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. The AESIs considered in this study are infusion-related reactions including immediate hypersensitivity, immune-related adverse events, skin adverse events, bleeding events and anemia.
    End point type
    Secondary
    End point timeframe
    Time from first study intervention up to 321 days
    End point values
    		 Bintrafusp alfa
    Number of subjects analysed
    11
    Units: Count of subjects
        Participants with TEAEs
    10
        Participants with Treatment-Related TEAEs
    5
        Participants with AESIs
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time from first study intervention up to 321 days.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Bintrafusp alfa
    Reporting group description
    		 Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

    Serious adverse events
    		 Bintrafusp alfa
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 11 (63.64%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    1
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    General physical health deterioration
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bintrafusp alfa
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 11 (81.82%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Asthenia
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Throat irritation
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Blood creatine phosphokinase increase
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Blood phosphorus increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Blood thyroid stimulating hormone dec
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Blood urea increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Thyroxine free increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Abdominal distension
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gingival bleeding
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Dry skin
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Infections and infestations
    Vaginal infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Diverticulitis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jul 2021
    Updates in the Risk Classification.

    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.
    Based on sponsors decision for early termination of the study due to lack of probability to achieve interim data allowing expansion of this study. Hence, analysis for efficacy, or biomarker were not performed.
    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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