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    Clinical Trial Results:
    Randomized phase II trial of combination chemotherapy with panitumumab or bevacizumab for patients with inoperable cholangiocarcinoma without KRAS mutations

    Summary
    EudraCT number
    2010-020385-13
    Trial protocol
    DK   SE  
    Global end of trial date
    31 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    52702928
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01206049
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vejle Hospital
    Sponsor organisation address
    Beriderbakken 4, Vejle, Denmark,
    Public contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    Scientific contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.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
    01 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the rate of progression free survival at 6 months in a comparable population of patients with inoperable cholangiocarcinoma treated with either GOC and panitumumab or GOC and bevacizumab.
    Protection of trial subjects
    Antiemetics and other supportive treatment offered as necessary
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Oct 2010
    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
    Denmark: 85
    Country: Number of subjects enrolled
    Sweden: 3
    Worldwide total number of subjects
    88
    EEA total number of subjects
    88
    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)
    38
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment from 15 October 2010 to 7 January 2015

    Pre-assignment
    Screening details
    Patients referred for first line treatment of inoperable cholangiocarcinoma without KRAS mutations.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A, panitumumab
    Arm description
    Combination chemotherapy (institutional practice) + panitumumab
    Arm type
    Experimental

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg day 1 every two weeks

    Arm title
    Arm B, Bevacizumab
    Arm description
    Combination chemotherapy (institutional guidelines) + bevacizumab
    Arm type
    Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/kg every two weeks

    Number of subjects in period 1
    Arm A, panitumumab Arm B, Bevacizumab
    Started
    45
    43
    Completed
    45
    43

    Baseline characteristics

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

    Reporting group values
    Overall trial Total
    Number of subjects
    88 88
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    38 38
        From 65-84 years
    50 50
        85 years and over
    0 0
    Age continuous
    Units: years
        median (full range (min-max))
    66 (35 to 84) -
    Gender categorical
    Units: Subjects
        Female
    55 55
        Male
    33 33

    End points

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    End points reporting groups
    Reporting group title
    Arm A, panitumumab
    Reporting group description
    Combination chemotherapy (institutional practice) + panitumumab

    Reporting group title
    Arm B, Bevacizumab
    Reporting group description
    Combination chemotherapy (institutional guidelines) + bevacizumab

    Primary: Fraction of patients alive and without progression at 6 months

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    End point title
    Fraction of patients alive and without progression at 6 months
    End point description
    End point type
    Primary
    End point timeframe
    6 month after randomization
    End point values
    Arm A, panitumumab Arm B, Bevacizumab
    Number of subjects analysed
    45
    43
    Units: Fraction
        arithmetic mean (confidence interval 95%)
    42 (29 to 58)
    53 (40 to 70)
    Statistical analysis title
    Simon's Two Stage
    Statistical analysis description
    Our study was based on Simon's two-stage design27 and two parallel Phase II trials with a primary endpoint of the fraction of PFS at 6 months. In both treatment arms, a PFS at 6 months of 65% was considered clinically relevant. The regimens were uninteresting if less than 45% of the patients reached a PFS of ≥6 months.
    Comparison groups
    Arm A, panitumumab v Arm B, Bevacizumab
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.05
    Method
    Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Every four weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Toxicity
    Reporting group description
    -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Focus was on SAE and the primary endpoint releated to efficacy. Standard drugs with well-known toxicity profile was used.
    Serious adverse events
    Toxicity
    Total subjects affected by serious adverse events
         subjects affected / exposed
    47 / 88 (53.41%)
         number of deaths (all causes)
    87
         number of deaths resulting from adverse events
    0
    Investigations
    Reduced general condition
         subjects affected / exposed
    4 / 88 (4.55%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thromboembolic event, Pulmonary embolism
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ischemia cerebrovascular
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    7 / 88 (7.95%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    Fatique
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    5 / 88 (5.68%)
         occurrences causally related to treatment / all
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    7 / 88 (7.95%)
         occurrences causally related to treatment / all
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 88 (3.41%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    6 / 88 (6.82%)
         occurrences causally related to treatment / all
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Oral hemorrhage
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 88 (3.41%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    5 / 88 (5.68%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Metastatic spinal cord compression
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fever
         subjects affected / exposed
    19 / 88 (21.59%)
         occurrences causally related to treatment / all
    18 / 37
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    4 / 88 (4.55%)
         occurrences causally related to treatment / all
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyperkalemia
         subjects affected / exposed
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Toxicity
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 88 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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    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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