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    Clinical Trial Results:
    A multicenter, randomized, double-blind, parallel group, placebo controlled, Phase 2 study to assess the efficacy and safety of ATX01 (topical amitriptyline hydrochloride 10% and 15% w/w) in comparison to placebo, in cancer survivor adult patients with chemotherapy-induced peripheral neuropathy (CIPN)

    Summary
    EudraCT number
    		 2022-000435-23
    Trial protocol
    		 FR   CZ   ES   BE  
    Global end of trial date
    18 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2025
    First version publication date
    06 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ATX01-22-01-CIPN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALGOTHERAPEUTIX SAS
    Sponsor organisation address
    49 avenue des Nouvelles , Suresnes, France,
    Public contact
    Philippe Picaut, AlgoTherapeutix, +33 683822424, philippe@algotx.com
    Scientific contact
    Philippe Picaut, AlgoTherapeutix, +33 683822424, philippe@algotx.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
    18 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of ATX01 compared to placebo in treating neuropathic pain in target study extremities in patients with CIPN.
    Protection of trial subjects
    Subjects recorded daily their pain levels which were regularly monitored by site personnel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Spain: 72
    Country: Number of subjects enrolled
    Belgium: 24
    Country: Number of subjects enrolled
    Czechia: 19
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Italy: 32
    Country: Number of subjects enrolled
    United States: 69
    Worldwide total number of subjects
    273
    EEA total number of subjects
    204
    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)
    164
    From 65 to 84 years
    109
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 395 patients were screened according to the inclusion and exclusion criteria defined in the protocol. 119 patients were screen failed and 276 patients were randomized with 3 patients never receiving the treatment (273 patients evaluable).

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

    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
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Twice a day for 12 weeks on hands and/or feet

    Arm title
    		 ATX01 15%
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATX01 15%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Twice a day for 12 weeks on hands and/or feet

    Arm title
    		 ATX01 10%
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATX01 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Twice a day for 12 weeks on hands and/or feet

    Number of subjects in period 1
    		Placebo ATX01 15% ATX01 10%
    Started
    89
    92
    92
    Completed
    78
    79
    76
    Not completed
    11
    13
    16
         Physician decision
    1
    -
    -
         Consent withdrawn by subject
    6
    8
    9
         Adverse event, non-fatal
    4
    4
    7
         Protocol deviation
    -
    1
    -

    Baseline characteristics

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

    Reporting group values
    		 Overall Total
    Number of subjects
    		 273 273
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 164 164
        From 65-84 years
    		 109 109
    Gender categorical
    Units: Subjects
        Female
    		 192 192
        Male
    		 81 81

    End points

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

    Reporting group title
    ATX01 15%
    Reporting group description
    		 -

    Reporting group title
    ATX01 10%
    Reporting group description
    		 -

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) is defined as all randomized patients who applied any amount of study drug and had both a weekly average NPRS derived at Baseline and at least 1 post-baseline 24-hour average pain intensity assessment (i.e. one NPRS diary entry).

    Primary: Change from baseline to Week 12 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.

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    End point title
    		 Change from baseline to Week 12 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.
    End point description
    End point type
    Primary
    End point timeframe
    Reported daily from baseline to Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    75
    74
    73
    Units: Not applicable
        arithmetic mean (standard deviation)
    -1.55 ( 1.581 )
    -1.61 ( 1.713 )
    -1.50 ( 1.560 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    ATX01 10% v Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.83
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.78
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of patients achieving ≥30% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12.

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    End point title
    		 Percentage of patients achieving ≥30% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    89
    91
    92
    Units: Not applicable
        arithmetic mean (standard deviation)
    33 ( 44 )
    33 ( 45 )
    27 ( 37 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.39
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.92
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of patients achieving ≥50% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12.

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    End point title
    		 Percentage of patients achieving ≥50% pain reduction from baseline in the weekly mean NPRS average pain intensity related to CIPN at Week 12.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    89
    91
    92
    Units: Not applicable
        arithmetic mean (standard deviation)
    18 ( 24 )
    16 ( 22 )
    13 ( 18 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.42
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.76
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Mean change from baseline to Week 12 in tingling/pins and needles intensity in target study extremities as measured by the numerical rating scale (NRS) assessing each symptom.

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    End point title
    		 Mean change from baseline to Week 12 in tingling/pins and needles intensity in target study extremities as measured by the numerical rating scale (NRS) assessing each symptom.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    51
    51
    46
    Units: Not applicable
        arithmetic mean (standard deviation)
    -1.7 ( 2.03 )
    -1.7 ( 1.88 )
    -1.5 ( 1.82 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.72
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline to Week 4 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.

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    End point title
    		 Change from baseline to Week 4 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    84
    89
    86
    Units: Not applicable
        arithmetic mean (standard deviation)
    -0.92 ( 1.281 )
    -0.93 ( 1.204 )
    -0.84 ( 1.168 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline to Week 8 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.

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    End point title
    		 Change from baseline to Week 8 in the weekly mean of the daily NPRS score assessing average pain intensity in target study extremities related to CIPN in the past 24 hours.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    81
    82
    78
    Units: not applicable
        arithmetic mean (standard deviation)
    -1.17 ( 1.575 )
    -1.17 ( 1.51 )
    -1.18 ( 1.336 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.89
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.91
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Number of patients with at least “improved” on the Patient Global Impression of Change at week 4.

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    End point title
    		 Number of patients with at least “improved” on the Patient Global Impression of Change at week 4.
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    75
    82
    78
    Units: number of patients
    37
    52
    33
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of patients with at least “improved” on the Patient Global Impression of Change at week 8

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    End point title
    		 Number of patients with at least “improved” on the Patient Global Impression of Change at week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    73
    74
    70
    Units: Number of patients
    38
    44
    36
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of patients with at least “improved” on the Patient Global Impression of Change at week 12

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    End point title
    		 Number of patients with at least “improved” on the Patient Global Impression of Change at week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    65
    64
    58
    Units: Number of patients
    39
    45
    35
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.99
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.22
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Mean change from baseline to Week 4 in pain interference with daily life using the Brief Pain Inventory-Short Form questionnaire (item 9 only).

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    End point title
    		 Mean change from baseline to Week 4 in pain interference with daily life using the Brief Pain Inventory-Short Form questionnaire (item 9 only).
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    87
    84
    88
    Units: not applicable
        arithmetic mean (standard deviation)
    -0.97 ( 1.69 )
    -0.99 ( 2.26 )
    -0.96 ( 2.12 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline to week 8 in pain interference with daily life using the Brief Pain Inventory-Short Form questionnaire (item 9 only).

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    End point title
    		 Mean change from baseline to week 8 in pain interference with daily life using the Brief Pain Inventory-Short Form questionnaire (item 9 only).
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    82
    82
    78
    Units: not applicable
        arithmetic mean (standard deviation)
    -1.08 ( 1.96 )
    -1.42 ( 1.913 )
    -1.12 ( 2.22 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline to week 12 in pain interference with daily life using the Brief Pain Inventory-Short Form questionnaire (item 9 only).

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    End point title
    		 Mean change from baseline to week 12 in pain interference with daily life using the Brief Pain Inventory-Short Form questionnaire (item 9 only).
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    79
    78
    72
    Units: not applicable
        arithmetic mean (standard deviation)
    -1.25 ( 2.26 )
    -1.81 ( 1.97 )
    -1.30 ( 2.04 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.88
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean change from baseline to Week 12 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN 20-item scale (EORTC-QLQ-CIPN20).

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    End point title
    		 Mean change from baseline to Week 12 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN 20-item scale (EORTC-QLQ-CIPN20).
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    79
    78
    73
    Units: not applicable
        arithmetic mean (standard deviation)
    -5.06 ( 8.28 )
    -7.40 ( 8.38 )
    -5.51 ( 8.44 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.16
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean change from baseline to Week 12 in numbness intensity in target study extremities as measured by the numerical rating scale (NRS) assessing each symptom.

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    End point title
    		 Mean change from baseline to Week 12 in numbness intensity in target study extremities as measured by the numerical rating scale (NRS) assessing each symptom.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    51
    55
    49
    Units: not applicable
        arithmetic mean (standard deviation)
    -1.4 ( 1.88 )
    -1.6 ( 2.07 )
    -1.5 ( 1.77 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.85
    Method
    		 ANCOVA
    Confidence interval

    Other pre-specified: Mean change from baseline to Week 12 in Total Neuropathy Score-nurse version (TNSn) total score.

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    End point title
    		 Mean change from baseline to Week 12 in Total Neuropathy Score-nurse version (TNSn) total score.
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 12
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    61
    63
    57
    Units: not applicable
        arithmetic mean (standard deviation)
    -1.57 ( 2.6 )
    -1.57 ( 2.75 )
    -1.19 ( 2.64 )
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 10%
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Placebo v ATX01 15%
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.76
    Method
    		 ANCOVA
    Confidence interval

    Other pre-specified: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) (or SAEs) leading to discontinuations.

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    End point title
    		 Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) (or SAEs) leading to discontinuations.
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Overall study duration
    End point values
    		 Placebo ATX01 15% ATX01 10%
    Number of subjects analysed
    89
    92
    92
    Units: number of patients
    4
    4
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening to Week 13
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    ATX01 15%
    Reporting group description
    		 -

    Reporting group title
    ATX01 10%
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo ATX01 15% ATX01 10%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 89 (3.37%)
    1 / 92 (1.09%)
    2 / 92 (2.17%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to peritoneum
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 92 (1.09%)
    0 / 92 (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
    Metastases to central nervous system
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 92 (0.00%)
    0 / 92 (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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 92 (0.00%)
    0 / 92 (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
    Intestinal obstruction
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 92 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Peritonitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 92 (0.00%)
    0 / 92 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo ATX01 15% ATX01 10%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 89 (15.73%)
    20 / 92 (21.74%)
    15 / 92 (16.30%)
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    10 / 89 (11.24%)
    11 / 92 (11.96%)
    6 / 92 (6.52%)
         occurrences all number
    13
    13
    8
    Application site dryness
         subjects affected / exposed
    0 / 89 (0.00%)
    6 / 92 (6.52%)
    7 / 92 (7.61%)
         occurrences all number
    0
    7
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 89 (4.49%)
    3 / 92 (3.26%)
    2 / 92 (2.17%)
         occurrences all number
    5
    3
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2023
    Modified inclusion and exclusion criteria to aid in recruitment of patients. Provided some clarifications on the study conduct.
    12 Jul 2023
    Removed the subset of 45 patients (15 per group) for extended PK assessment (12+hours) and added additional PK samples for all patients. Plus, a few modifications of the inclusion and exclusion criteria for easier recruitment.

    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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