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    Clinical Trial Results:
    An open label multicentric phase II study of Panitumumab (Vectibix®) in cutaneous squamous cell carcinoma (SCC)

    Summary
    EudraCT number
    2009-015237-76
    Trial protocol
    BE  
    Global end of trial date
    17 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Mar 2021
    First version publication date
    17 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LUC 09-002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01129154
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Cliniques universitairtes Saint-Luc
    Sponsor organisation address
    Avenue Hippocrate, 10, Brussels, Belgium, 1200
    Public contact
    Jean-François Baurain, Cliniques universitaires Saint-Luc, +32 2 7645471, jean-francois.baurain@uclouvain.be
    Scientific contact
    Jean-François Baurain , Cliniques universitaires Saint-Luc, +32 2 7645471, jean-francois.baurain@uclouvain.be
    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 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Overall Response Rate (ORR)
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) régulations/guidelines, and country-specific national and local laws. Description AE management in the protocol.
    Background therapy
    PANITUMUMAB (Vectibix®)
    Evidence for comparator
    No active RI in this discase at this stage.
    Actual start date of recruitment
    10 Sep 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
    Belgium: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    3
    From 65 to 84 years
    7
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    Dermatology consultation from September 2010 till May2016.

    Pre-assignment
    Screening details
    NA

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

    Arms
    Arm title
    PANITUMUMAB – Vectibix ARM
    Arm description
    Experimental treatment
    Arm type
    Experimental

    Investigational medicinal product name
    PANITUMUMAB
    Investigational medicinal product code
    Other name
    Vectibix
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg p 2 weeks

    Number of subjects in period 1
    PANITUMUMAB – Vectibix ARM
    Started
    18
    Completed
    15
    Not completed
    3
         Adverse event, non-fatal
    3

    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
    18 18
    Age categorical
    Ages Eligible for Study: 18 years and older (Adult)
    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)
    3 3
        From 65-84 years
    7 7
        85 years and over
    8 8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    79.4 ± 13.6 -
    Gender categorical
    Sexes Eligible for Study: All
    Units: Subjects
        Female
    7 7
        Male
    11 11

    End points

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    End points reporting groups
    Reporting group title
    PANITUMUMAB – Vectibix ARM
    Reporting group description
    Experimental treatment

    Primary: Overall Response Rate (ORR)

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    End point title
    Overall Response Rate (ORR) [1]
    End point description
    To measure the efficacy of Panitumumab for SCC in terms of Overall Response Rate (ORR). Overall Response Rate (ORR) is defined as the sum of complete and partial tumour responses seen, divided by the total number of evaluable patients. Imaging evaluation will be done via photography and CT-scan, MRI or PET-scan every 6 weeks on 2 occasions, then every 12 weeks. Response evaluation will be assessed according Modified RECIST version 1.1. Patient will be declared progressive at that time if their clinical situation requires an immediate alternative treatment. Response evaluation will be assessed at week 12. Best observed response will also be recorded.
    End point type
    Primary
    End point timeframe
    Via imaging every 12 weeks
    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: Only descriptive statistical analysis has been performed. ORR and duration of response measured according to modified RECIST version 1.1. Responders and non-responders subjects compared for their demographic parameters, by Fisher exact and Student T tests, according to the type of variables. The Kaplan-Meier technique used to obtain the TTF and the TTP. Subjects without evidence of progression at the end of follow up considered as censored. Proportion of all adverse events are reported.
    End point values
    PANITUMUMAB – Vectibix ARM
    Number of subjects analysed
    15
    Units: percent
        number (not applicable)
    36.4
    No statistical analyses for this end point

    Secondary: Progression free survival (PFS)

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    End point title
    Progression free survival (PFS)
    End point description
    PFS is defined as the time from date of first dose of study medication to first occurrence of any following event: documentation of objective tumor progression, toxicities requiring prematurely stop of treatment or death.
    End point type
    Secondary
    End point timeframe
    Via imaging, every 12 weeks.
    End point values
    PANITUMUMAB – Vectibix ARM
    Number of subjects analysed
    15
    Units: months
        median (full range (min-max))
    4.4 (1.2 to 15.9)
    No statistical analyses for this end point

    Secondary: overall survival (OS)

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    End point title
    overall survival (OS)
    End point description
    Duration of overall response measured according RECIST guidelines version 1.1. Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
    End point type
    Secondary
    End point timeframe
    Via imaging, every 12 weeks.
    End point values
    PANITUMUMAB – Vectibix ARM
    Number of subjects analysed
    15
    Units: months
        median (full range (min-max))
    12.6 (1.2 to 70.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Serious AE occurring at any time after the patient has signed the informed consent, the screening visit, and within 30 days of the last day on which the investigational agent was administered must be reported within 24 hours of awareness of the event.
    Adverse event reporting additional description
    Adverse Events attributes assigned by the investigator: AE diagnosis or syndrome(s); event description; dates of onset and resolution; severity; assessment of relatedness to study treatment; and action taken.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    PANITUMUMAB - Vectibix ARM
    Reporting group description
    6 SAE occurred in study, all due to a patient hospitalization. The 6 were not related to the study drug, and 3 resolved without sequelae.

    Serious adverse events
    PANITUMUMAB - Vectibix ARM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 15 (40.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Cerebellous infarction
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac infarction
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
    Additional description: Due to an underlying gastroenteritis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General condition impairment
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Deshydratation
    Additional description: Due to an esophageal dysphagia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fever with shivers and Testicle pus collection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PANITUMUMAB - Vectibix ARM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 15 (86.67%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Anemia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 15 (60.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin rash acne/acneiform (Pustulosis)
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    1
    Skin rash acne/acneiform
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    1
    Skin Erythema
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin dryness
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    1
    Nail changes
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    1
    Xerosis, skin dryness
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypomagnesia
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    1
    Hypokalemia
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    1
    Hypocalcemia
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    1
    Hyperkalemia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    Paronychia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2009
    1.1 Protocol classification
    29 Dec 2009
    1.2 Protocol classification

    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
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