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    Clinical Trial Results:
    Multi-centric randomized phase II study of pre-operative Afatinib (BIBW2992) aiming at identifying predictive and pharmacodynamic biomarkers of biological activity and efficacy in untreated non-metastatic head and neck squamous cell carcinoma patients

    Summary
    EudraCT number
    2010-024046-29
    Trial protocol
    FR  
    Global end of trial date
    06 Jan 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Apr 2021
    First version publication date
    24 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GEP 11/1010
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01415674
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 RUE DE TOLBIAC, PARIS, France, 75013
    Public contact
    N. AIT RAHMOUNE, UNICANCER, 33 (0) 1 71 93 67 04, n.ait-rahmoune@unicancer.fr
    Scientific contact
    N. AIT RAHMOUNE, UNICANCER, 33 (0)171936704, n.ait-rahmoune@unicancer.fr
    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
    11 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify potential predictive biomarkers of efficacy by exploring correlation between baseline potential biomarkers and: a. radiological response to Afatinib b. FDG-PET response to Afatinib
    Protection of trial subjects
    In order to ensure the protection of the rights, safety and well-being of trial subjects, this clinical trial was performed in compliance with the principles laid down in the declaration of Helsinki, good Clinical Practice and European regulation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Jan 2012
    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
    France: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    42
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients with untreated, operable, non-metastatic squamous cell carcinoma of the head and neck

    Pre-assignment
    Screening details
    Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinus and nasal cavity, oropharynx, larynx or hypopharynx, previously untreated, amenable to curative treatment with surgery. Patients with a diagnosis of SCCHN of occult primary may be enrolled only with the agreement of the lead investigator upon revie

    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
    Afatinib
    Arm description
    Afatinib will be administered orally at the dose of 40 mg per day on a continuous schedule for 14 to 28 days, depending on the date of surgery.
    Arm type
    Experimental

    Investigational medicinal product name
    Afatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Afatinib will be administered orally at the dose of 40 mg per day on a continuous schedule for 14 to 28 days, depending on the date of surgery.

    Arm title
    No treatment
    Arm description
    No treatment
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Afatinib No treatment
    Started
    41
    20
    Completed
    41
    18
    Not completed
    0
    2
         SURGERY NOT PERFORMED
    -
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Afatinib
    Reporting group description
    Afatinib will be administered orally at the dose of 40 mg per day on a continuous schedule for 14 to 28 days, depending on the date of surgery.

    Reporting group title
    No treatment
    Reporting group description
    No treatment

    Reporting group values
    Afatinib No treatment Total
    Number of subjects
    41 20 61
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    31 14 45
        From 65-84 years
    10 6 16
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    9 14 23
        Male
    32 6 38

    End points

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    End points reporting groups
    Reporting group title
    Afatinib
    Reporting group description
    Afatinib will be administered orally at the dose of 40 mg per day on a continuous schedule for 14 to 28 days, depending on the date of surgery.

    Reporting group title
    No treatment
    Reporting group description
    No treatment

    Primary: EFFICACY ON FDG-PET PER PERCIST

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    End point title
    EFFICACY ON FDG-PET PER PERCIST
    End point description
    Number of patients with response to treatment excluding lymph nodes
    End point type
    Primary
    End point timeframe
    Efficacy will be defined as the tumour reduction between baseline and surgery (end of treatment).
    End point values
    Afatinib No treatment
    Number of subjects analysed
    41
    20
    Units: number
    24
    0
    Statistical analysis title
    EFFICACY ON FDG-PET PER PERCIST
    Statistical analysis description
    EFFICACY ON FDG-PET PER PERCIST
    Comparison groups
    Afatinib v No treatment
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Fisher exact
    Parameter type
    Mean difference (final values)
    Confidence interval

    Secondary: EFFICACY ON CT/MRI PER RECIST 1.1

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    End point title
    EFFICACY ON CT/MRI PER RECIST 1.1
    End point description
    Number of patients with response to treatment
    End point type
    Secondary
    End point timeframe
    CT Scan or MRI must be done within one week prior surgery
    End point values
    Afatinib No treatment
    Number of subjects analysed
    41
    20
    Units: Number
    2
    0
    Statistical analysis title
    EFFICACY ON CT/MRI PER RECIST
    Comparison groups
    Afatinib v No treatment
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Fisher exact
    Parameter type
    Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were reported during all the period of the trial
    Adverse event reporting additional description
    Adverse events (not serious) are not available and not reported here
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Arm A (with afatinib)
    Reporting group description
    -

    Reporting group title
    Arm B (without afatinib)
    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: Non serious adverse events not available
    Serious adverse events
    Arm A (with afatinib) Arm B (without afatinib)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 41 (24.39%)
    5 / 20 (25.00%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Bleeding postoperative
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft ischemia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative bleeding
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumopathy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphocele
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis oral
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral cavity fistula
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Necrosis skin
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative infection
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purulent discharge
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Arm A (with afatinib) Arm B (without afatinib)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jan 2012
    New name of the sponsor
    31 Jan 2012
    protocol was updated (modification of 2 inclusion criteria)
    02 Apr 2012
    Submission of new IB
    19 Jul 2012
    Protocole updated (precision concerning inclusion criteria)
    03 Sep 2012
    submission of new IB
    27 May 2013
    inclusion period extended
    03 Oct 2013
    Submission of new IB
    07 Apr 2014
    IMPD was updated
    23 May 2014
    Protocol updated and inclusion period extended
    21 Oct 2014
    Submission of new IB

    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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