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    Clinical Trial Results:
    Phase IIa (therapeutic exploratory), multicenter, randomized, double-blind, placebocontrolled, 2-stage, 4-arm study exploring the effect of BST204 on cancer-related cachexia in patients with gastrointestinal or non-small-cell lung cancer

    Summary
    EudraCT number
    2017-003271-61
    Trial protocol
    DE  
    Global end of trial date
    13 Oct 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BST204C02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GREEN CROSSWellbeing
    Sponsor organisation address
    33F, Tower-2 108, Yeoui-daero, Yeongdeungpo-gu, Seoul, Korea, Republic of, 07335
    Public contact
    Project Management, PSI CRO AG, +43 1205159911, Natalia.Peppi@psi-cro.com
    Scientific contact
    Project Management, PSI CRO AG, +43 1205159911, Natalia.Peppi@psi-cro.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 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective is to explore the efficacy of BST204 in cancer-related cachexia
    Protection of trial subjects
    The Protocol and any amendments and the Informed Consent Form (ICF) were reviewed and approved by the Independent Ethics Committee (IEC) before the study was initiated. Any amendments to the Protocol or changes to the ICF required IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study participants. This study was conducted in accordance with the Protocol and consensus ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Aug 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
    Ukraine: 80
    Country: Number of subjects enrolled
    Georgia: 16
    Country: Number of subjects enrolled
    Germany: 7
    Worldwide total number of subjects
    103
    EEA total number of subjects
    7
    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)
    64
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The studies were conducted at 18 centers across 3 countries, between 06 AUG 2018 (FPFV) and 13 OCT 2020 (LPLV).

    Pre-assignment
    Screening details
    A total of 130 patients were screened, 109 (83.8%) of which met the eligibility criteria. All screening failures did not meet the eligibility criteria. One patient who met the eligibility criteria was not randomized, and 2 patients who did not meet the eligibility criteria were randomized in error. Therefore, 110 patients were randomized.

    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
    Investigator, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    400mg (2x100mg capsules twice daily)

    Arm title
    BST204
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    BST204
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    400mg (2x100mg capsules twice daily)

    Number of subjects in period 1
    Placebo BST204
    Started
    37
    66
    Completed
    26
    53
    Not completed
    11
    13
         Consent withdrawn by subject
    -
    3
         wrong primary endpoint test measurement
    1
    -
         due to progress of disease
    5
    2
         due to COVID-19
    -
    3
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    4
    3
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    BST204
    Reporting group description
    -

    Reporting group values
    Placebo BST204 Total
    Number of subjects
    37 66 103
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18 years and over)
    37 66 103
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.1 ± 11.91 61.5 ± 8.48 -
    Gender categorical
    Units: Subjects
        Female
    12 28 40
        Male
    25 38 63
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All patients of the Original FAS who were compliant with the exposure to the treatment regimen (at least 80% of total dose), who had no major protocol deviations, and for whom stair climb power change from baseline could be determined after 4, 8, and 12 weeks of treatment were to be included in the Original PPS. The primary endpoint variable analysis from the Original PPS was to be used to evaluate efficacy of BST204.

    Subject analysis set title
    BST204
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All subjects of FAS who are compliant with the exposure to the treatment regimen (at least 80% of total dose), who have no major protocol deviations, and for whom stair climb power change from baseline can be determined after 4, 8, and 12 weeks of treatment will be included in the PPS.

    Subject analysis sets values
    Placebo BST204
    Number of subjects
    26
    53
    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 years and over)
    26
    53
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.9 ± 13.09
    61.6 ± 8.05
    Gender categorical
    Units: Subjects
        Female
    10
    24
        Male
    16
    29

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    BST204
    Reporting group description
    -

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All patients of the Original FAS who were compliant with the exposure to the treatment regimen (at least 80% of total dose), who had no major protocol deviations, and for whom stair climb power change from baseline could be determined after 4, 8, and 12 weeks of treatment were to be included in the Original PPS. The primary endpoint variable analysis from the Original PPS was to be used to evaluate efficacy of BST204.

    Subject analysis set title
    BST204
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All subjects of FAS who are compliant with the exposure to the treatment regimen (at least 80% of total dose), who have no major protocol deviations, and for whom stair climb power change from baseline can be determined after 4, 8, and 12 weeks of treatment will be included in the PPS.

    Primary: Stair climb power test

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    End point title
    Stair climb power test
    End point description
    End point type
    Primary
    End point timeframe
    changes from baseline after 8 and 12 weeks of treatment to obtain the slope of change from baseline to Week 12.
    End point values
    Placebo BST204
    Number of subjects analysed
    26
    53
    Units: watt
        least squares mean (standard error)
    15.59 ± 5.83
    14.62 ± 4.08
    Statistical analysis title
    Efficacy
    Statistical analysis description
    The slope of stair climb power changes from baseline to week 12 of treatment with BST204 or placebo will be compared separately for each cancer group. A Mixed-effects Model Repeat Measurement (MMRM) model with baseline value as a covariate and treatment as fixed effect will be applied. For comparison of the treatments, two-sided 95% confidence intervals for the mean differences in slope and corresponding time point estimators adjusted for baseline will be computed.
    Comparison groups
    Placebo v BST204
    Number of subjects included in analysis
    79
    Analysis specification
    Post-hoc
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Mixed models analysis
    Confidence interval

    Secondary: Lean Body Mass

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    End point title
    Lean Body Mass
    End point description
    End point type
    Secondary
    End point timeframe
    changes from baseline after 8 and 12 weeks of treatment to obtain the slope of change from baseline to Week 12.
    End point values
    Placebo BST204
    Number of subjects analysed
    26
    53
    Units: kg
        least squares mean (standard error)
    0.13 ± 0.45
    -0.24 ± 0.32
    No statistical analyses for this end point

    Secondary: Body weight

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    End point title
    Body weight
    End point description
    End point type
    Secondary
    End point timeframe
    changes from baseline after 4, 8, and 12 weeks of treatment to obtain the slope of change from baseline to Week 12.
    End point values
    Placebo BST204
    Number of subjects analysed
    26
    53
    Units: kg
        least squares mean (standard error)
    1.48 ± 0.41
    0.62 ± 0.29
    No statistical analyses for this end point

    Secondary: 6-min walking test

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    End point title
    6-min walking test
    End point description
    End point type
    Secondary
    End point timeframe
    changes from baseline after 4, 8, and 12 weeks of treatment to obtain the slope of change from baseline to Week 12.
    End point values
    Placebo BST204
    Number of subjects analysed
    26
    53
    Units: meter
        least squares mean (standard error)
    26.36 ± 10.67
    14.13 ± 7.47
    No statistical analyses for this end point

    Secondary: Handgrip strength

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    End point title
    Handgrip strength
    End point description
    End point type
    Secondary
    End point timeframe
    changes from baseline after 4, 8, and 12 weeks of treatment to obtain the slope of change from baseline to Week 12.
    End point values
    Placebo BST204
    Number of subjects analysed
    26
    53
    Units: kg
        least squares mean (standard error)
    -0.04 ± 0.72
    -0.04 ± 0.50
    No statistical analyses for this end point

    Secondary: Quality of life (QoL)

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    End point title
    Quality of life (QoL)
    End point description
    End point type
    Secondary
    End point timeframe
    changes from baseline in appetite after 4, 8, and 12 weeks of treatment in questionnaire scores (Functional Assessment of Anorexia/Cachexia [FAACT] questionnaire) to obtain the slope of change from baseline to Week 12.
    End point values
    Placebo BST204
    Number of subjects analysed
    26
    53
    Units: score
        least squares mean (standard error)
    9.65 ± 2.43
    2.88 ± 1.70
    No statistical analyses for this end point

    Secondary: Fatigue

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    End point title
    Fatigue
    End point description
    End point type
    Secondary
    End point timeframe
    changes from baseline after 4, 8, and 12 weeks of treatment in questionnaire scores (Functional Assessment of Chronic Illness Therapy [FACIT] questionnaire) to obtain the slope of change from baseline to Week 12.
    End point values
    Placebo BST204
    Number of subjects analysed
    26
    53
    Units: score
        least squares mean (standard error)
    5.69 ± 1.80
    3.44 ± 1.26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from baseline up to 12 weeks (End of trial) post dose, up to 2 weeks after end of trial.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    BST204
    Reporting group description
    -

    Serious adverse events
    Placebo BST204
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 37 (18.92%)
    7 / 66 (10.61%)
         number of deaths (all causes)
    5
    3
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decrease
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         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
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 37 (2.70%)
    5 / 66 (7.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromatic anaemia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoventilation
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureteric obstruction
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocaliectasis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo BST204
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 37 (83.78%)
    54 / 66 (81.82%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 37 (2.70%)
    7 / 66 (10.61%)
         occurrences all number
    1
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 37 (10.81%)
    17 / 66 (25.76%)
         occurrences all number
    9
    26
    Neutropenia
         subjects affected / exposed
    5 / 37 (13.51%)
    14 / 66 (21.21%)
         occurrences all number
    6
    17
    Leukopenia
         subjects affected / exposed
    3 / 37 (8.11%)
    10 / 66 (15.15%)
         occurrences all number
    4
    11
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 37 (18.92%)
    8 / 66 (12.12%)
         occurrences all number
    9
    15
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 37 (21.62%)
    14 / 66 (21.21%)
         occurrences all number
    10
    25
    Diarrhoea
         subjects affected / exposed
    5 / 37 (13.51%)
    9 / 66 (13.64%)
         occurrences all number
    8
    16
    Vomiting
         subjects affected / exposed
    1 / 37 (2.70%)
    7 / 66 (10.61%)
         occurrences all number
    1
    8
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    6 / 37 (16.22%)
    9 / 66 (13.64%)
         occurrences all number
    10
    10
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 37 (2.70%)
    7 / 66 (10.61%)
         occurrences all number
    1
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Nov 2017
    - Introduction of additional pregnancy test - Definition of upper limit of age - Exclusion criteria regarding vital signs - Revision of statement for exclusion criteria - Change in notation of Sponsor name - Correction of Sponsor telephone number
    27 Feb 2018
    - Change of randomization numbers - Introduction of time window for Follow-up visit - Introduction of calculation of the Glomerular filtration rate [GFR] at Visit 3 to 6 - Addition of urine sample for safety laboratory in the flow chart - Revision of method description of stair climb power test - Removal of fasting state for safety laboratory - Revision of description for the use of flags in laboratory and vital signs listings - Removal of source data book for eCRF creation
    06 Jul 2018
    - Revision of inclusion criterion regarding NSCLC diagnosis and therapy - Addition of exclusion criterion regarding pacemaker - Inclusion of assessment of protein-losing enteropathy at Screening - Revision of withdrawal criterion regarding alpha-1-antitrypsin - Deletion of measurement of LBM via DXA at Visits 3 and 4 - Clarification of stool collection including written consent process

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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

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