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    Clinical Trial Results:
    Randomized, Placebo-Controlled, Double Blind Phase 2 Study of Patritumab (U3-1287) in Combination with Cetuximab plus Platinum Based Therapy in First Line Setting in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

    Summary
    EudraCT number
    		 2015-002222-40
    Trial protocol
    		 GB   DE   HU   BE  
    Global end of trial date
    21 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2018
    First version publication date
    21 Sep 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U31287-A-U203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02633800
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo, Inc.
    Sponsor organisation address
    211 Mt. Airy Road, Basking Ridge, New Jersey, United States, 07920
    Public contact
    Clinical Study Director, Daiichi Sankyo , Inc., 1 9089926400,
    Scientific contact
    Clinical Study Director, Daiichi Sankyo , Inc., 1 9089926400,
    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
    05 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the ICH Harmonised Tripartite Guideline.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2015
    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
    Poland: 5
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 39
    Worldwide total number of subjects
    87
    EEA total number of subjects
    87
    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)
    59
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of 125 screened, 87 patients from 8 countries were randomized into treatment groups

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patritumab
    Arm description
    		 Patritumab + cetuximab + cisplatin or carboplatin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Patritumab
    Investigational medicinal product code
    Other name
    U3-1287, Monoclonal antibody
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patritumab + cetuximab + cisplatin or carboplatin

    Arm title
    		 Placebo
    Arm description
    		 Placebo + cetuximab + cisplatin or carboplatin
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo comparator
    Pharmaceutical forms
    Solution for infusion in administration system
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo + cetuximab + cisplatin or carboplatin

    Number of subjects in period 1
    		Patritumab Placebo
    Started
    44
    43
    Completed
    0
    0
    Not completed
    44
    43
         Clinical progression
    3
    6
         Consent withdrawn by subject
    -
    3
         Radiological progression
    -
    23
         Adverse event, non-fatal
    7
    2
         Death
    3
    3
         Patient request
    1
    1
         Study terminated by sponsor
    6
    5
         Radiologic progression
    23
    -
         Reason not provided
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patritumab
    Reporting group description
    		 Patritumab + cetuximab + cisplatin or carboplatin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo + cetuximab + cisplatin or carboplatin

    Reporting group values
    		 Patritumab Placebo Total
    Number of subjects
    		 44 43 87
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 32 27 59
        From 65-84 years
    		 12 16 28
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.3 ± 9.18 61.0 ± 9.19 -
    Gender categorical
    Units: Subjects
        Female
    		 8 7 15
        Male
    		 36 36 72
    Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
    The baseline value is defined as the last non-missing value before initial administration of study treatment.
    Units: Subjects
        0=Fully active
    		 19 22 41
        1=Restricted in Physically Strenuous Activity
    		 25 20 45
        2=Ambulatory and Capable of All Self-Care
    		 0 1 1
        3=Capable of Only Limited Self Care
    		 0 0 0
        4=Completely Disabled
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Patritumab
    Reporting group description
    		 Patritumab + cetuximab + cisplatin or carboplatin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo + cetuximab + cisplatin or carboplatin

    Primary: Progression free survival (PFS) in the heregulin (HRG)-high expression population

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    End point title
    		 Progression free survival (PFS) in the heregulin (HRG)-high expression population
    End point description
    PFS is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever comes first. Median PFS is from Kaplan-Meier analysis. CI for median was computed using Brookmeyer-Crowley method.
    End point type
    Primary
    End point timeframe
    until radiological progression or death (or at study termination)
    End point values
    		 Patritumab Placebo
    Number of subjects analysed
    26
    25
    Units: months
        median (confidence interval 95%)
    5.56 (4.08 to 11.18)
    5.56 (3.06 to 8.29)
    Statistical analysis title
    		 Heregulin-high population - Patritumab vs Placebo
    Statistical analysis description
    Both Log-rank test and Cox regression analysis did not adjust stratification factors.
    Comparison groups
    Patritumab v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8342 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9291
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4856
         upper limit
    		 1.7778
    Notes
    [1] - Unstratified Log-rank p-value

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival could not be analyzed with the data available at trial termination.
    End point type
    Secondary
    End point timeframe
    Date of randomization to death due to any cause
    End point values
    		 Patritumab Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - The trial terminated before sufficient data were collected for this analysis.
    [3] - The trial terminated before sufficient data were collected for this analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected until trial termination at 12 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Patritumab + Cetuximab + Platinum Based Therapy
    Reporting group description
    		 -

    Reporting group title
    Placebo + Cetuximab + Platinum Based Therapy
    Reporting group description
    		 -

    Serious adverse events
    		 Patritumab + Cetuximab + Platinum Based Therapy Placebo + Cetuximab + Platinum Based Therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 44 (43.18%)
    16 / 43 (37.21%)
         number of deaths (all causes)
    24
    20
         number of deaths resulting from adverse events
    5
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 44 (0.00%)
    4 / 43 (9.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tumour pain
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Localised oedema
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acquired tracheo-oesophageal fistula
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lower respiratory tract congestion
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia aspiration
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Ejection Fraction Decreased
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (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
    Fall
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Disorder
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Myocardial ischaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Decreased Appetite
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (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
    		 Patritumab + Cetuximab + Platinum Based Therapy Placebo + Cetuximab + Platinum Based Therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 44 (100.00%)
    42 / 43 (97.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 44 (4.55%)
    3 / 43 (6.98%)
         occurrences all number
    2
    4
    Hypotension
         subjects affected / exposed
    3 / 44 (6.82%)
    4 / 43 (9.30%)
         occurrences all number
    3
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 44 (22.73%)
    11 / 43 (25.58%)
         occurrences all number
    14
    17
    Chills
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 43 (4.65%)
         occurrences all number
    5
    2
    Fatigue
         subjects affected / exposed
    11 / 44 (25.00%)
    7 / 43 (16.28%)
         occurrences all number
    14
    9
    Mucosal inflammation
         subjects affected / exposed
    8 / 44 (18.18%)
    2 / 43 (4.65%)
         occurrences all number
    13
    2
    Oedema peripheral
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Pyrexia
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 43 (2.33%)
         occurrences all number
    7
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 44 (11.36%)
    5 / 43 (11.63%)
         occurrences all number
    7
    5
    Dyspnoea
         subjects affected / exposed
    7 / 44 (15.91%)
    5 / 43 (11.63%)
         occurrences all number
    12
    8
    Haemoptysis
         subjects affected / exposed
    4 / 44 (9.09%)
    3 / 43 (6.98%)
         occurrences all number
    5
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 44 (4.55%)
    3 / 43 (6.98%)
         occurrences all number
    2
    3
    Depression
         subjects affected / exposed
    2 / 44 (4.55%)
    3 / 43 (6.98%)
         occurrences all number
    2
    3
    Insomnia
         subjects affected / exposed
    4 / 44 (9.09%)
    4 / 43 (9.30%)
         occurrences all number
    4
    6
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 43 (4.65%)
         occurrences all number
    6
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 43 (2.33%)
         occurrences all number
    5
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    6
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    4
    Weight Decreased
         subjects affected / exposed
    11 / 44 (25.00%)
    10 / 43 (23.26%)
         occurrences all number
    16
    12
    Weight increased
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 43 (6.98%)
         occurrences all number
    1
    5
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    5
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Dysgeusia
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 43 (0.00%)
         occurrences all number
    4
    0
    Headache
         subjects affected / exposed
    3 / 44 (6.82%)
    5 / 43 (11.63%)
         occurrences all number
    4
    6
    Paraesthesia
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    18 / 44 (40.91%)
    13 / 43 (30.23%)
         occurrences all number
    34
    22
    Leukocytosis
         subjects affected / exposed
    5 / 44 (11.36%)
    0 / 43 (0.00%)
         occurrences all number
    5
    0
    Neutropenia
         subjects affected / exposed
    13 / 44 (29.55%)
    11 / 43 (25.58%)
         occurrences all number
    23
    22
    Thrombocytopenia
         subjects affected / exposed
    10 / 44 (22.73%)
    14 / 43 (32.56%)
         occurrences all number
    20
    39
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    7 / 44 (15.91%)
    5 / 43 (11.63%)
         occurrences all number
    7
    7
    Diarrhoea
         subjects affected / exposed
    12 / 44 (27.27%)
    5 / 43 (11.63%)
         occurrences all number
    18
    6
    Dysphagia
         subjects affected / exposed
    8 / 44 (18.18%)
    4 / 43 (9.30%)
         occurrences all number
    10
    4
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Nausea
         subjects affected / exposed
    16 / 44 (36.36%)
    14 / 43 (32.56%)
         occurrences all number
    23
    22
    Oral Pain
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Stomatitis
         subjects affected / exposed
    5 / 44 (11.36%)
    3 / 43 (6.98%)
         occurrences all number
    9
    3
    Vomiting
         subjects affected / exposed
    9 / 44 (20.45%)
    7 / 43 (16.28%)
         occurrences all number
    11
    14
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    15 / 44 (34.09%)
    8 / 43 (18.60%)
         occurrences all number
    20
    17
    Dry skin
         subjects affected / exposed
    6 / 44 (13.64%)
    7 / 43 (16.28%)
         occurrences all number
    7
    8
    Pruritus
         subjects affected / exposed
    3 / 44 (6.82%)
    3 / 43 (6.98%)
         occurrences all number
    3
    3
    Rash
         subjects affected / exposed
    20 / 44 (45.45%)
    21 / 43 (48.84%)
         occurrences all number
    42
    28
    Rash Maculo-Papular
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 43 (4.65%)
         occurrences all number
    5
    2
    Skin fissures
         subjects affected / exposed
    7 / 44 (15.91%)
    6 / 43 (13.95%)
         occurrences all number
    8
    13
    Skin toxicity
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Neck pain
         subjects affected / exposed
    3 / 44 (6.82%)
    4 / 43 (9.30%)
         occurrences all number
    6
    10
    Pain in extremity
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    6 / 44 (13.64%)
    4 / 43 (9.30%)
         occurrences all number
    6
    5
    Folliculitis
         subjects affected / exposed
    2 / 44 (4.55%)
    5 / 43 (11.63%)
         occurrences all number
    3
    6
    Paronychia
         subjects affected / exposed
    15 / 44 (34.09%)
    4 / 43 (9.30%)
         occurrences all number
    25
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    11 / 44 (25.00%)
    11 / 43 (25.58%)
         occurrences all number
    14
    17
    Hypercalcaemia
         subjects affected / exposed
    3 / 44 (6.82%)
    3 / 43 (6.98%)
         occurrences all number
    3
    3
    Hypokalaemia
         subjects affected / exposed
    11 / 44 (25.00%)
    2 / 43 (4.65%)
         occurrences all number
    15
    5
    Hypomagnesaemia
         subjects affected / exposed
    16 / 44 (36.36%)
    15 / 43 (34.88%)
         occurrences all number
    29
    35
    Hyponatraemia
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Hypophosphataemia
         subjects affected / exposed
    2 / 44 (4.55%)
    5 / 43 (11.63%)
         occurrences all number
    6
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Aug 2015
    - Added sample collections for additional biomarkers - Revised text on contraception based on Medicines and Healthcare products Regulatory Agency (MHRA) feedback
    29 Jan 2016
    - Added assessments, exclusions and clarified procedural details to enhance patient safety and welfare - Adjusted text as needed to ensure using local standard of care for the chemotherapy is acceptable per protocol.
    14 Jun 2016
    - Changes made to reflect the recommendation by European Regulatory Authorities for new guidance regarding maintenance dose modification or suspension of patritumab treatment for possible effects on cardiac function, and the addition of three new exclusion criteria - Removed sentence that does not include full details for patritimab infusion bag instructions. Full/revised instructions are provided in a separate updated Pharmacy Manual: “The selected dose of patritumab/placebo regimen will be diluted in 5% dextrose in a final volume of 100 mL.” - Added paragraph noting that left ventricular ejection fraction (LVEF) will be monitored throughout the study and that dose modifications in patritumab will be according to guidance in Table 5.1, and ejection fraction Withhold Criteria and Discontinuation Criteria for patritumab are more precisely defined Administrative change of sponsoring entity to a different Daiichi Sankyo company.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Feb 2018
    Trial was terminated by sponsor due to lack of efficacy.
    -

    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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    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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