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    Clinical Trial Results:
    Effektivitätsoptimierte und toxizitätsreduzierte Therapie des metastasierten Kolorektalkarzinoms in der First-line Therapie

    Summary
    EudraCT number
    		 2006-002744-28
    Trial protocol
    		 DE  
    Global end of trial date
    16 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2016
    First version publication date
    25 Jun 2016
    Other versions
    Summary report(s)
    		 ERBIMOX Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    IOM-510-2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    iOMEDICO AG
    Sponsor organisation address
    Hanferstraße 28, Freiburg, Germany, 79108
    Public contact
    iOMEDICO AG Dr. Sabine Busies Director BU Clinical Research, iOMEDICO AG Dr. Sabine Busies Director BU Clinical Research, 0049 0761 1524214, sabine.busies@iomedico.com
    Scientific contact
    iOMEDICO AG Dr. Sabine Busies Director BU Clinical Research, iOMEDICO AG Dr. Sabine Busies Director BU Clinical Research, 0049 0761 1524214, sabine.busies@iomedico.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
    15 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To verify the superiority of a combined chemo-immuno-therapy compared to exclusive chemotherapy (ie, to demonstrate superiority of additional cetucimab to modified FOLFOX 7 compared to modified FOLFOX 7 alone) in first-line treatment of patients with KRAS wild-type metastatic colorectal cancer, in terms of objective response rate (ORR).
    Protection of trial subjects
    The study was conducted in compliance with the protocol, according to ICH-GCP current local laws and regulations, and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Oct 2006
    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
    Germany: 191
    Worldwide total number of subjects
    191
    EEA total number of subjects
    191
    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)
    80
    From 65 to 84 years
    111
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The ERBIMOX study was an open-label, randomized, two-arm, multicenter, phase II study of first-line treatment in mCRC. Patients were randomly assigned (1:1) to receive modified FOLFOX7 with or without cetuximab. Patients were enrolled at office-based medical oncology practices.

    Pre-assignment
    Screening details
    		 Time of screening period: 30 days without a pre-assignment period. Patients were enrolled if inclusion and exclusion criteria were met. In total N = 196 patients were screened and randomized.

    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
    		 Arm A - Optimox
    Arm description
    		 Modified FOLFOX 7 was administred for 8 two-weekly cycles of induction period, stopping oxaliplatin during subsequent maintenance period persisting until disease progression.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    modified FOLFOX 7
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin (folinic acid, FA) 400 mg/m2 Fluorouracil (5-FU) 2,400 mg/m2 over 48 hours Oxaliplatin 85 mg/m2 only for 8 two-weekly cycles (induction period)

    Arm title
    		 Arm B - Erbimox
    Arm description
    		 Adding continously cetuximab to modified FOLFOX 7 for the 8 two-weekly induction period followed by subsequent maintanance period without oxaliplatin until disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    EMD271786
    Other name
    Erbitux
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weekly 250 mg/m2 day 1 and day 8 of each two-weekly cycle; first cetuximab administration 400 mg/m2

    Number of subjects in period 1
    		Arm A - Optimox Arm B - Erbimox
    Started
    95
    96
    Completed
    63
    75
    Not completed
    32
    21
         KRAS mutation status unknown
    15
    12
         KRAS mutation status positive
    17
    -
         'KRAS tumor status positve '
    -
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A - Optimox
    Reporting group description
    		 Modified FOLFOX 7 was administred for 8 two-weekly cycles of induction period, stopping oxaliplatin during subsequent maintenance period persisting until disease progression.

    Reporting group title
    Arm B - Erbimox
    Reporting group description
    		 Adding continously cetuximab to modified FOLFOX 7 for the 8 two-weekly induction period followed by subsequent maintanance period without oxaliplatin until disease progression.

    Reporting group values
    		 Arm A - Optimox Arm B - Erbimox Total
    Number of subjects
    		 95 96 191
    Age categorical
    Number of patients per category
    Units: Subjects
        18 - 64 years
    		 45 35 80
        >=65 years
    		 50 61 111
    Age continuous
    Units: years
        median (full range (min-max))
    		 65.6 (38.4 to 77.8) 67.4 (38.9 to 82.6) -
    Gender categorical
    Units: Subjects
        Female
    		 27 34 61
        Male
    		 68 62 130
    Site of tumor
    Units: Subjects
        Colon
    		 48 52 100
        Rectum
    		 47 44 91
    Subject analysis sets

    Subject analysis set title
    Modified Intent-to-treat
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized patients with verified KRAS wild-type tumor, who received at least one dose of study medication.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set

    Subject analysis sets values
    		 Modified Intent-to-treat Safety
    Number of subjects
    138
    191
    Age categorical
    Number of patients per category
    Units: Subjects
        18 - 64 years
    59
    80
        >=65 years
    79
    111
    Age continuous
    Units: years
        median (full range (min-max))
    66.9 (38.4 to 82.1)
    67.2 (38.4 to 82.6)
    Gender categorical
    Units: Subjects
        Female
    43
    61
        Male
    95
    130
    Site of tumor
    Units: Subjects
        Colon
    67
    100
        Rectum
    71
    91

    End points

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    End points reporting groups
    Reporting group title
    Arm A - Optimox
    Reporting group description
    		 Modified FOLFOX 7 was administred for 8 two-weekly cycles of induction period, stopping oxaliplatin during subsequent maintenance period persisting until disease progression.

    Reporting group title
    Arm B - Erbimox
    Reporting group description
    		 Adding continously cetuximab to modified FOLFOX 7 for the 8 two-weekly induction period followed by subsequent maintanance period without oxaliplatin until disease progression.

    Subject analysis set title
    Modified Intent-to-treat
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized patients with verified KRAS wild-type tumor, who received at least one dose of study medication.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set

    Primary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    End point type
    Primary
    End point timeframe
    During treatment until disesase progression, death, or any cause of permanent treatment discontinuation
    End point values
    		 Arm A - Optimox Arm B - Erbimox Modified Intent-to-treat
    Number of subjects analysed
    63 [1]
    75 [2]
    138
    Units: Number of complete and partial responses
    34
    48
    82
    Notes
    [1] - Total of m-ITT analysis set
    [2] - Total number of m-ITT analysis set
    Statistical analysis title
    		 Cochran-Mantel-Haenszel
    Statistical analysis description
    Comparison of response rates between treatment groups
    Comparison groups
    Arm B - Erbimox v Arm A - Optimox
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 chi-square
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE reporting whilst patients are on treatment, including 30 days follow-up period after permanent treatment discontinuation.
    Adverse event reporting additional description
    Only grade 3/4 serious and non-serious adverse events are reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.3
    Reporting groups
    Reporting group title
    Arm B - Erbimox
    Reporting group description
    		 Cetuximab continuously administered to modified FOLFOX 7 during the induction period (ie, eight two-weekly cycles) and during the subsequent maintenance period without oxaliplatin until progressive disease, unacceptable toxicity or withdrawal of consent.

    Reporting group title
    Arm A Optimox
    Reporting group description
    		 -

    Serious adverse events
    		 Arm B - Erbimox Arm A Optimox
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 96 (36.46%)
    25 / 95 (26.32%)
         number of deaths (all causes)
    53
    44
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Subileus
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extravasation
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mucosal inflammation
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dispnoea
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Biopsy liver
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    1 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemias NEC
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 96 (4.17%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    4 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    1 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Obstructive uropathy
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 96 (4.17%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    4 / 35
    1 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Arm B - Erbimox Arm A Optimox
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 96 (54.17%)
    30 / 95 (31.58%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Ovarian cancer
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Surgical and medical procedures
    Jejunostomy refashioning
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 96 (1.04%)
    23 / 95 (24.21%)
         occurrences all number
    43
    30
    Fatigue
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Mucosal inflammation
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Pain
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Investigations
    Blood magnesium decreased
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Blood glucose increased
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Liver function test abnormal
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Epilepsy
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Loss of consciousness
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Paraesthesia
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Polyneuropathy
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Leukopenia
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Neutropenia
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 95 (2.11%)
         occurrences all number
    43
    23
    Thrombocytopenia
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Gastrointestinal disorders
    Anal inflammation
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Constipation
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 95 (3.16%)
         occurrences all number
    43
    23
    Diarrhoea
         subjects affected / exposed
    3 / 96 (3.13%)
    4 / 95 (4.21%)
         occurrences all number
    43
    23
    Gastritis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Nausea
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Oesophagitis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Vomiting
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Skin and subcutaneous tissue disorders
    Dermal and epidermal conditions NEC
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Dermatitis acneiform
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Nail bed inflammation
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Photosensitivity reaction
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 95 (2.11%)
         occurrences all number
    43
    23
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Fracture pain
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Limb discomfort
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Device related infection
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Febrile infection
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    43
    23
    Paronychia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Dehydration
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23
    Hypokalaemia
         subjects affected / exposed
    3 / 96 (3.13%)
    0 / 95 (0.00%)
         occurrences all number
    43
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2008
    Restriction of study population to patients with confirmed KRAS wild-type mCRC. Patients under treatment who had confirmed KRAS mutation status had to stop study treatment.
    18 Jun 2009
    Change of cetuximab IMP to labeled marketing drug supply

    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.
    Due to the substantial amendment that only confirmed KRAS wild-type patients were allowed in future to proceed study medication recruitment process was slowed down and patients under treatment with KRAS mutated tumor were withdrawn from study.
    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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