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    Clinical Trial Results:
    Phase II trial of capecitabine (Xeloda®) + nab-paclitaxel (Abraxane®) in patients with metastatic pancreatic cancer

    Summary
    EudraCT number
    		 2013-001714-15
    Trial protocol
    		 AT  
    Global end of trial date
    22 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2021
    First version publication date
    19 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Met.Panc.01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedUniWien
    Sponsor organisation address
    Spitalgasse 23, Wien, Austria, 1090
    Public contact
    Marika Rosner, MedUniWien, +43 14040044450, marika.rosner@meduniwien.ac.at
    Scientific contact
    Markus Raderer, MedUniWien, +43 14040044450, markus.raderer@meduniwien.ac.at
    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
    31 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Objective response rate of Capecitabine + Nab-Paclitaxel as first-line chemotherapy in patients with metastatic pancreatic cancer
    Protection of trial subjects
    CT Thorax/Abdomen every 8 weeks
    Background therapy
    		 antiemetics before and 3 days after administration of nab-paclitaxel
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Aug 2013
    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
    Austria: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    16
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between December 2013 and January 2015, 30 patients were enrolled into this single-Center at the University Hospital Vienna.

    Pre-assignment
    Screening details
    		 30 patients were screened according to the inclusion and exclusion criteria

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

    Arms
    Arm title
    		 treatment arm
    Arm description
    		 There is only one arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m2 intravenously on days 1 and 8) every 3 weeks

    Investigational medicinal product name
    capacitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capecitabine 825 mg/m2, day 1 to 15,every 3 weeks.

    Number of subjects in period 1
    		treatment arm
    Started
    30
    Completed
    29
    Not completed
    1
         Adverse event, non-fatal
    1

    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
    		 30 30
    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)
    		 16 16
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Objective response rate of Capecitabine + Nab-Paclitaxel as first-line chemotherapy in patients with metastatic pancreatic cancer

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    30
    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)
    16
        From 65-84 years
    14
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    14
        Male
    16

    End points

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    End points reporting groups
    Reporting group title
    treatment arm
    Reporting group description
    		 There is only one arm

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Objective response rate of Capecitabine + Nab-Paclitaxel as first-line chemotherapy in patients with metastatic pancreatic cancer

    Primary: Objective tumor response

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    End point title
    		 Objective tumor response
    End point description
    Objective tumor response according to RECIST criteria
    End point type
    Primary
    End point timeframe
    From baseline until end of treatment
    End point values
    		 treatment arm Overall trial
    Number of subjects analysed
    30
    30
    Units: number
    30
    30
    Statistical analysis title
    		 Objective response rate
    Comparison groups
    treatment arm v Overall trial
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Simon’s two-stage design
    Confidence interval
    Notes
    [1] - descriptive statistics

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    after the patient has signed the informed consent form until post treatment visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Treatment-related AEs
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment-related AEs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 30 (16.67%)
         number of deaths (all causes)
    17
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    neutopenia
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment-related AEs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    17 / 30 (56.67%)
         occurrences all number
    23
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    18 / 30 (60.00%)
         occurrences all number
    18
    Anaemia
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 30 (33.33%)
         occurrences all number
    10

    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.
    no limitations

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27034791
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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
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