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    Clinical Trial Results:
    A MULTINATIONAL, RANDOMIZED, PHASE II STUDY OF THE COMBINATION OF NAB-PACLITAXEL AND GEMCITABINE WITH OR WITHOUT IL-6R INHIBITOR, TOCILIZUMAB, AS FIRST-LINE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER.

    Summary
    EudraCT number
    		 2016-000643-13
    Trial protocol
    		 DK   NO  
    Global end of trial date
    18 Jul 2022

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GI1612
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02767557
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev & Gentofte Hospital, Department of Oncology
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark, 2730
    Public contact
    Inna Chen, Herlev & Gentofte Hospital, +45 38682898, inna.chen@regionh.dk
    Scientific contact
    Inna Chen, Herlev & Gentofte Hospital, +45 38682898, inna.chen@regionh.dk
    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
    09 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare overall survival at 6 months of gemcitabine/nab-paclitaxel plus tocilizumab and gemcitabine/nab-paclitaxel.
    Protection of trial subjects
    Patients that signed informed consent and fulfilling eligibility criteria were included. Continued monitoring of standard safety parameters during treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2017
    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
    Norway: 1
    Country: Number of subjects enrolled
    Denmark: 146
    Worldwide total number of subjects
    147
    EEA total number of subjects
    147
    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)
    62
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was opened for recruitment in January 2017 and closed for enrollment in July 2021 . Patients were included at 2 sites, Copenhagen University Hospital - Herlev and Gentofte in Denmark and Oslo University Hospital, Norway.

    Pre-assignment
    Screening details
    		 Eligible patients were ≥ 18 years with locally advanced or metastatic pancreatic cancer, who had not previously received treatment in the advanced setting, ECOG PS 0-1, mGPS >=1, with measureable disease and adequate organ and hematologic function.

    Period 1
    Period 1 title
    Protocol Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Prior to randomised portion of the trial, a safety cohort of 6 participants recieved experimental treatment (unrandomised). 141 participants were randomly assigned to experimental and standard treatment, stratification by ECOG PS (0 vs 1) and stage of disease (locally advanced vs metastatic.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Safety Cohort
    Arm description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    1000 mg/m² i.v. on day 1, day 8 and day 15 of every 28 day cycle.

    Investigational medicinal product name
    nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² i.v. on day 1, day 8 and day 15 of every 28 day cycle.

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg given i.v. on day 1 of every 28 day cycle.

    Arm title
    		 Gem/Nab/Toc
    Arm description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    1000 mg/m² i.v. on day 1, day 8 and day 15 of every 28 day cycle.

    Investigational medicinal product name
    nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² i.v. on day 1, day 8 and day 15 of every 28 day cycle.

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg given i.v. on day 1 of every 28 day cycle.

    Arm title
    		 Gem/Nab
    Arm description
    		 Gemcitabine and nab-paclitaxel Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    1000 mg/m² i.v. on day 1, day 8 and day 15 of every 28 day cycle.

    Investigational medicinal product name
    nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² i.v. on day 1, day 8 and day 15 of every 28 day cycle.

    Number of subjects in period 1
    		Safety Cohort Gem/Nab/Toc Gem/Nab
    Started
    6
    70
    71
    Completed
    5
    47
    53
    Not completed
    1
    23
    18
         Adverse event, serious fatal
    -
    4
    2
         Consent withdrawn by subject
    -
    2
    5
         Physician decision
    -
    2
    1
         Adverse event, non-fatal
    -
    9
    6
         Death from disease under study
    1
    4
    3
         Resection of tumor
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Safety Cohort
    Reporting group description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Gem/Nab/Toc
    Reporting group description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Gem/Nab
    Reporting group description
    		 Gemcitabine and nab-paclitaxel Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group values
    		 Safety Cohort Gem/Nab/Toc Gem/Nab Total
    Number of subjects
    		 6 70 71 147
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 69.5 (49 to 76) 68 (34 to 84) 67 (36 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 3 30 28 61
        Male
    		 3 40 43 86
    ECOG Performance status
    Units: Subjects
        ECOG PS 0
    		 2 26 27 55
        ECOG PS 1
    		 4 44 44 92
    Disease Stage
    Units: Subjects
        Locally advanced
    		 0 5 6 11
        Metastatic
    		 6 65 65 136
    Subject analysis sets

    Subject analysis set title
    Efficacy analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients randomised to either Gem/Nab/Toc or Gem/Nab and recieved at treatment at least once

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Both the patients that were included in the safety cohort (Gem/Nab/Toc) and those randomised to either Gem/Nab/Toc or Gem/Nab and having received treatment at least once.

    Subject analysis sets values
    		 Efficacy analysis Safety
    Number of subjects
    141
    147
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    67 (34 to 84)
    67 (34 to 84)
    Gender categorical
    Units: Subjects
        Female
    58
    61
        Male
    83
    86
    ECOG Performance status
    Units: Subjects
        ECOG PS 0
    53
    55
        ECOG PS 1
    88
    92
    Disease Stage
    Units: Subjects
        Locally advanced
    11
    11
        Metastatic
    130
    136

    End points

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    End points reporting groups
    Reporting group title
    Safety Cohort
    Reporting group description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Gem/Nab/Toc
    Reporting group description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Gem/Nab
    Reporting group description
    		 Gemcitabine and nab-paclitaxel Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Subject analysis set title
    Efficacy analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients randomised to either Gem/Nab/Toc or Gem/Nab and recieved at treatment at least once

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Both the patients that were included in the safety cohort (Gem/Nab/Toc) and those randomised to either Gem/Nab/Toc or Gem/Nab and having received treatment at least once.

    Primary: OS rate at 6 months

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    End point title
    		 OS rate at 6 months [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months from randomisation
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety cohort of 6 patients is not included in the efficacy endpoint, which was analysed in for patients in the randomised part of the trial
    End point values
    		 Gem/Nab/Toc Gem/Nab
    Number of subjects analysed
    70
    71
    Units: percent
        number (confidence interval 95%)
    68.6 (56.3 to 78.1)
    62 (49.6 to 72.1)
    Statistical analysis title
    		 Comparison of OS rate at specific timepoint
    Comparison groups
    Gem/Nab/Toc v Gem/Nab
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.409
    Method
    		 z-test
    Confidence interval

    Secondary: Overall Survival

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    End point title
    		 Overall Survival [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Time from randomisation to death
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety cohort of 6 patients is not included in the efficacy endpoint, which was analysed in for patients in the randomised part of the trial
    End point values
    		 Gem/Nab/Toc Gem/Nab
    Number of subjects analysed
    70
    71
    Units: months
        median (confidence interval 95%)
    8.4 (6.7 to 11.4)
    8.0 (5.9 to 9.8)
    Statistical analysis title
    		 Overall survival
    Comparison groups
    Gem/Nab/Toc v Gem/Nab
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.096
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.05

    Secondary: Progression free survival

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    End point title
    		 Progression free survival [3]
    End point description
    End point type
    Secondary
    End point timeframe
    time from randomisation to radiological progression or death
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety cohort of 6 patients is not included in the efficacy endpoint, which was analysed in for patients in the randomised part of the trial
    End point values
    		 Gem/Nab/Toc Gem/Nab
    Number of subjects analysed
    70
    71
    Units: month
        median (confidence interval 95%)
    5.6 (3.9 to 7.4)
    5.5 (3.5 to 7.0)
    Statistical analysis title
    		 PFS
    Comparison groups
    Gem/Nab/Toc v Gem/Nab
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.339
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.19

    Secondary: Objective response rate

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    End point title
    		 Objective response rate [4]
    End point description
    End point type
    Secondary
    End point timeframe
    tumor assessment every 8 weeks from treatment start
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety cohort of 6 patients is not included in the efficacy endpoint, which was analysed in for patients in the randomised part of the trial
    End point values
    		 Gem/Nab/Toc Gem/Nab
    Number of subjects analysed
    70
    71
    Units: percent
        number (confidence interval 95%)
    37.1 (25.9 to 45.9)
    35.2 (24.2 to 47.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time from treatment start to 30 days after last treatment
    Adverse event reporting additional description
    For non-serious AE section, only AEs with causal relationship to treatment (AR) are listed (numbers includes subjects/occurences reported as SARs as well).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Safety Cohort
    Reporting group description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Gem/Nab/Toc
    Reporting group description
    		 Gemcitabine and nab-paclitaxel in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Gem/Nab
    Reporting group description
    		 Gemcitabine and nab-paclitaxel Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Serious adverse events
    		 Safety Cohort Gem/Nab/Toc Gem/Nab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
    49 / 70 (70.00%)
    40 / 71 (56.34%)
         number of deaths (all causes)
    6
    70
    71
         number of deaths resulting from adverse events
    0
    4
    2
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombotic angiopathy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Portal vein thrombosis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Capillary leak syndrome
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 70 (0.00%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Edema limbs
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    flu like symptoms
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 70 (5.71%)
    5 / 71 (7.04%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Pneumothorax
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Hypoxia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 70 (0.00%)
    0 / 71 (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
    Psychiatric disorders
    Mania
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Neutropenia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         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
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Cerebral infarction
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 70 (5.71%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Constipation
         subjects affected / exposed
    0 / 6 (0.00%)
    7 / 70 (10.00%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
    7 / 70 (10.00%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    1 / 1
    8 / 8
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Pancreatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Vomiting
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 70 (4.29%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 70 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder obstruction
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Hepatic failure
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Renal and urinary disorders
    Bladder spasm
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Urinary retention
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
    9 / 70 (12.86%)
    7 / 71 (9.86%)
         occurrences causally related to treatment / all
    1 / 1
    10 / 12
    5 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    15 / 70 (21.43%)
    7 / 71 (9.86%)
         occurrences causally related to treatment / all
    0 / 0
    14 / 19
    5 / 8
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
    Infection unknown focus
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 70 (4.29%)
    5 / 71 (7.04%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    7 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Abscess
         subjects affected / exposed
    0 / 6 (0.00%)
    5 / 70 (7.14%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 6
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 70 (2.86%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 70 (2.86%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    infection due to necrosis/liver infarct
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Abdominal infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Epididymitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    4 / 71 (5.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary candida infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Ketosis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 70 (1.43%)
    0 / 71 (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
    Dehydration
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    1 / 71 (1.41%)
         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
    		 Safety Cohort Gem/Nab/Toc Gem/Nab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    70 / 70 (100.00%)
    71 / 71 (100.00%)
    Investigations
    Thrombocytopenia
         subjects affected / exposed
    3 / 6 (50.00%)
    54 / 70 (77.14%)
    35 / 71 (49.30%)
         occurrences all number
    10
    292
    124
    Neutropenia
         subjects affected / exposed
    4 / 6 (66.67%)
    51 / 70 (72.86%)
    29 / 71 (40.85%)
         occurrences all number
    10
    212
    75
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 6 (33.33%)
    37 / 70 (52.86%)
    17 / 71 (23.94%)
         occurrences all number
    6
    71
    30
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    5 / 6 (83.33%)
    46 / 70 (65.71%)
    46 / 71 (64.79%)
         occurrences all number
    13
    113
    100
    Peripheral motor neuropathy
         subjects affected / exposed
    3 / 6 (50.00%)
    22 / 70 (31.43%)
    16 / 71 (22.54%)
         occurrences all number
    7
    46
    33
    Dizziness
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 70 (2.86%)
    4 / 71 (5.63%)
         occurrences all number
    2
    2
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 6 (50.00%)
    48 / 70 (68.57%)
    45 / 71 (63.38%)
         occurrences all number
    7
    150
    104
    Fever
         subjects affected / exposed
    2 / 6 (33.33%)
    4 / 70 (5.71%)
    10 / 71 (14.08%)
         occurrences all number
    2
    6
    19
    flu/flu like symptoms
         subjects affected / exposed
    1 / 6 (16.67%)
    5 / 70 (7.14%)
    6 / 71 (8.45%)
         occurrences all number
    1
    5
    6
    Oedema
         subjects affected / exposed
    2 / 6 (33.33%)
    29 / 70 (41.43%)
    17 / 71 (23.94%)
         occurrences all number
    5
    68
    35
    Pain
    Additional description: Includes different verbatims such as pain + abdominal pain+ pain in extremity+ chest wall pain
         subjects affected / exposed
    1 / 6 (16.67%)
    11 / 70 (15.71%)
    5 / 71 (7.04%)
         occurrences all number
    2
    16
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    7 / 70 (10.00%)
    12 / 71 (16.90%)
         occurrences all number
    2
    9
    27
    Febrile neutropenia
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 70 (8.57%)
    3 / 71 (4.23%)
         occurrences all number
    1
    6
    3
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 70 (2.86%)
    3 / 71 (4.23%)
         occurrences all number
    3
    5
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 6 (66.67%)
    44 / 70 (62.86%)
    45 / 71 (63.38%)
         occurrences all number
    14
    102
    91
    Nausea
         subjects affected / exposed
    3 / 6 (50.00%)
    41 / 70 (58.57%)
    41 / 71 (57.75%)
         occurrences all number
    4
    90
    79
    Vomiting
         subjects affected / exposed
    2 / 6 (33.33%)
    22 / 70 (31.43%)
    21 / 71 (29.58%)
         occurrences all number
    2
    35
    30
    Haemorrhage
    Additional description: Includes different types of hemorrhage; mostly as GI but also vaginal , hematuria, epsitaxis, subconjunctiva
         subjects affected / exposed
    2 / 6 (33.33%)
    8 / 70 (11.43%)
    6 / 71 (8.45%)
         occurrences all number
    3
    11
    7
    Mucositis
         subjects affected / exposed
    4 / 6 (66.67%)
    20 / 70 (28.57%)
    14 / 71 (19.72%)
         occurrences all number
    10
    34
    22
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 6 (16.67%)
    7 / 70 (10.00%)
    7 / 71 (9.86%)
         occurrences all number
    1
    8
    12
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 70 (4.29%)
    5 / 71 (7.04%)
         occurrences all number
    0
    4
    7
    Skin and subcutaneous tissue disorders
    Nail ridging
         subjects affected / exposed
    2 / 6 (33.33%)
    4 / 70 (5.71%)
    4 / 71 (5.63%)
         occurrences all number
    4
    6
    9
    Rash
         subjects affected / exposed
    1 / 6 (16.67%)
    12 / 70 (17.14%)
    12 / 71 (16.90%)
         occurrences all number
    1
    22
    15
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    11 / 70 (15.71%)
    5 / 71 (7.04%)
         occurrences all number
    0
    14
    5
    Infection
    Additional description: includes infections of unknown focus, Pneumonia, Urinary tract, Clostridium difficile, Upper Respiratory tract, Pulmonary candida, Biliary tract , Cholecystitis, groin, Epididymitis, Herpes, Eye, Nail , Erysipelas, Skin, Wound ,foot
         subjects affected / exposed
    2 / 6 (33.33%)
    28 / 70 (40.00%)
    28 / 71 (39.44%)
         occurrences all number
    7
    55
    43
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    3 / 6 (50.00%)
    31 / 70 (44.29%)
    32 / 71 (45.07%)
         occurrences all number
    5
    53
    60
    Hypokalaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 70 (0.00%)
    4 / 71 (5.63%)
         occurrences all number
    0
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2016
    Additional laboratory test for lipid profile at start of each cycle. Addiotnal tumor biopsy at time of progression (if feasible and at the discretion of investigator)
    01 May 2018
    - Additional center at Oslo University Hospital - additional exploratory objective and endpoints were added to assess whether inhibition of IL-6R has an impact on cachexia in patients with locally advanced or metastatic pancreatic cancer - Adjustment to study time lines
    04 Dec 2018
    After interim safety analysis - implementation of Mandatory supportive treatment with G-CSF: In cycle 1 all patients will receive G-CSF (self-administrated) on day 9, i.e. 24 hours after administration of chemotherapy on day 8, or on day 8 in the clinic if self-administration is not an option. Upon reference all PACTO patients must be admitted and if ANC < 1.0 x 109/L is observed, G-CSF and antibiotics (tazocin and metronidazole) will be initiated, regardless of fever or CRP. Antibiotics should be adjusted / discontinued dependent on clinic thereafter. Additionally clarification anf corrections in the protocol base on comments from Norvegian Competent authority
    08 Dec 2019
    Adjustment of study timelines

    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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