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    Clinical Trial Results:
    Dose-escalation, PK and safety study with single agent CetuGEXTM in patients with locally advanced and/or metastatic cancer.

    Summary
    EudraCT number
    		 2010-019552-50
    Trial protocol
    		 DE  
    Global end of trial date
    14 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2019
    First version publication date
    25 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GEXMab52101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01222637
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Glycotope GmbH
    Sponsor organisation address
    Robert-Roessle-Str. 10, Berlin, Germany, 13125
    Public contact
    Dr. Alfredo Zurlo, Glycotope GmbH, 030 94892600, alfredo.zurlo@glycotope.com
    Scientific contact
    Dr. Alfredo Zurlo, Glycotope GmbH, 030 94892600, alfredo.zurlo@glycotope.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
    16 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To evaluate the safety and tolerability profile of CetuGEXTM at various dose levels •To define the recommended phase II dose and regimen
    Protection of trial subjects
    The safety data during the study were monitored on a continued basis by an Independent Drug Safety Monitoring Board (DSMB) comprising of 3 experienced physicians. In general, the DSMB provided recommendations if the study could continue as planned in the study protocol, if changes were needed from a safety point of view, or if the maximum tolerated dose (MTD) was reached.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Aug 2010
    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
    Germany: 26
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Switzerland: 9
    Worldwide total number of subjects
    41
    EEA total number of subjects
    32
    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)
    27
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first enrollment: 25 Aug 2010 Date of last completed: 14 Nov 2013

    Pre-assignment
    Screening details
    		 Male or female patients equal or greater 18 years of age with a histologically confirmed locally advanced and/or metastatic solid organ tumor. Patients enrolled in Germany were required to have a positive EGFR overexpression status. Patients must have experienced a failure or non-availability of standard therapy.

    Period 1
    Period 1 title
    Intent-to-treat (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    no blinding

    Arms
    Arm title
    		 CetuGEX
    Arm description
    		 no other arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    CetuGEX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weekly doses of 12 mg, 60 mg, 120 mg, 240 mg, 480 mg, 720 mg, 990 mg, or 1370 mg CetuGEX™ or dosing every 2 weeks of 990 mg CetuGEX™ administered by an intravenous Infusion.

    Number of subjects in period 1
    		CetuGEX
    Started
    41
    Completed
    41

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intent-to-treat
    Reporting group description
    		 -

    Reporting group values
    		 Intent-to-treat Total
    Number of subjects
    		 41 41
    Age categorical
    Units: Subjects
        Adults >= 18 years
    		 41 41
    Age continuous
    Adults >= 18 years
    Units: years
        arithmetic mean (standard deviation)
    		 59.8 ± 10.53 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 29 29

    End points

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    End points reporting groups
    Reporting group title
    CetuGEX
    Reporting group description
    		 no other arm

    Primary: safety profile adverse event

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    End point title
    		 safety profile adverse event [1]
    End point description
    End point type
    Primary
    End point timeframe
    All adverse events occurring after the patient entered the study until 28+2 days following the last infusion have been reported.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The number and percentage of patients with treatment-emergent adverse events (TEAEs) were summarized for each cohort and in total for each dosing scheme by system organ class (SOC) and preferred term (PT).
    End point values
    		 CetuGEX
    Number of subjects analysed
    41
    Units: numbers
    41
    No statistical analyses for this end point

    Secondary: Pharmacokinetics

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    End point title
    		 Pharmacokinetics
    End point description
    End point type
    Secondary
    End point timeframe
    2 Treatment Cycles
    End point values
    		 CetuGEX
    Number of subjects analysed
    41
    Units: milligram(s)
        number (not applicable)
    41
    No statistical analyses for this end point

    Secondary: preliminary evaluation of anti-tumor activity

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    End point title
    		 preliminary evaluation of anti-tumor activity
    End point description
    End point type
    Secondary
    End point timeframe
    every 8 weeks until tumor progression
    End point values
    		 CetuGEX
    Number of subjects analysed
    41
    Units: millimeter(s)
        number (not applicable)
    41
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events occurring after the patient entered the study until 28+2 days following the last infusion have been reported.us
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 The Intent-to-Treat (ITT) Population included any patient who was enrolled in a cohort and received any amount of study drug.

    Serious adverse events
    		 Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 41 (34.15%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    4
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    1 / 4
    General physical health deterioration
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences causally related to treatment / all
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    Stent malfunction
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 41 (2.44%)
         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
    		 Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 41 (100.00%)
    Investigations
    Blood magnesium decreased
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    17
    C-reactive protein increased
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    5
    Vascular disorders
    Oedema peripheral
         subjects affected / exposed
    9 / 41 (21.95%)
         occurrences all number
    13
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    7
    General disorders and administration site conditions
    Nausea
         subjects affected / exposed
    13 / 41 (31.71%)
         occurrences all number
    32
    Vomiting
         subjects affected / exposed
    12 / 41 (29.27%)
         occurrences all number
    32
    ECOG status worsened
         subjects affected / exposed
    12 / 41 (29.27%)
         occurrences all number
    22
    Fatigue
         subjects affected / exposed
    11 / 41 (26.83%)
         occurrences all number
    20
    Asthenia
         subjects affected / exposed
    9 / 41 (21.95%)
         occurrences all number
    19
    Pyrexia
         subjects affected / exposed
    9 / 41 (21.95%)
         occurrences all number
    14
    General physical health deterioration
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences all number
    15
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    14
    Abdominal pain
         subjects affected / exposed
    8 / 41 (19.51%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    16
    Cough
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    15
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    23
    Rash
         subjects affected / exposed
    12 / 41 (29.27%)
         occurrences all number
    30
    Dermatitis acneiform
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    33
    dry skin
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    7
    Pruritus
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    9 / 41 (21.95%)
         occurrences all number
    13
    Pain in extremity
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences all number
    14
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    10
    Urinary tract infection
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 41 (19.51%)
         occurrences all number
    10
    Hypokalaemia
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    20

    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
    For support, Contact us.
    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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