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    Clinical Trial Results:
    A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels

    The data reported in v1 is not correct and has been removed from public view
    Summary
    EudraCT number
    2012-000317-36
    Trial protocol
    ES   SE   GB   BE   DK  
    Global end of trial date
    09 Dec 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    29 Apr 2016
    First version publication date
    10 Feb 2016
    Other versions
    v1 (removed from public view)
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    0646-025
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01609231
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    09 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with dalotuzumab + irinotecan therapy relative to participants treated with cetuximab + irinotecan. The primary study hypothesis is that administration of dalotuzumab in combination with irinotecan to participants with wild-type KRAS metastatic rectal carcinoma with high IGF-1/low IGF-2 expression levels improves progression-free survival compared to participants treated with cetuximab in combination with irinotecan.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Jul 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
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Spain: 3
    Worldwide total number of subjects
    11
    EEA total number of subjects
    4
    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)
    5
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants with metastatic rectal carcinoma with high levels of tumor IGF-1/low levels of tumor IGF-2 and a wild type KRAS (wtKRAS) genotype, who experience disease progression on, or following, oxaliplatin and irinotecan–based chemotherapy and eligible to receive EGFR inhibitors.

    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
    Dalotuzumab + irinotecan
    Arm description
    Participants receive irinotecan intravenously (IV), 180 mg/m^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly
    Arm type
    Experimental

    Investigational medicinal product name
    irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV administration

    Investigational medicinal product name
    dalotuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV adminisration

    Arm title
    Cetuximab + irinotecan
    Arm description
    Participants receive cetuximab IV, initial dose of 400 mg/m^2 and then 250 mg/m^2 IV weekly + irinotecan IV, 180 mg/m^2 once every two weeks
    Arm type
    Active comparator

    Investigational medicinal product name
    irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV administration

    Investigational medicinal product name
    cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV administration

    Number of subjects in period 1
    Dalotuzumab + irinotecan Cetuximab + irinotecan
    Started
    6
    5
    Completed
    3
    2
    Not completed
    3
    3
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    1
    -
         Physician decision
    1
    -
         Adverse event, non-fatal
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dalotuzumab + irinotecan
    Reporting group description
    Participants receive irinotecan intravenously (IV), 180 mg/m^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly

    Reporting group title
    Cetuximab + irinotecan
    Reporting group description
    Participants receive cetuximab IV, initial dose of 400 mg/m^2 and then 250 mg/m^2 IV weekly + irinotecan IV, 180 mg/m^2 once every two weeks

    Reporting group values
    Dalotuzumab + irinotecan Cetuximab + irinotecan Total
    Number of subjects
    6 5 11
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    4 1 5
        From 65-84 years
    2 4 6
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    57.2 ± 13.8 64.6 ± 9.9 -
    Gender Categorical
    Units: Subjects
        Female
    3 2 5
        Male
    3 3 6

    End points

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    End points reporting groups
    Reporting group title
    Dalotuzumab + irinotecan
    Reporting group description
    Participants receive irinotecan intravenously (IV), 180 mg/m^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly

    Reporting group title
    Cetuximab + irinotecan
    Reporting group description
    Participants receive cetuximab IV, initial dose of 400 mg/m^2 and then 250 mg/m^2 IV weekly + irinotecan IV, 180 mg/m^2 once every two weeks

    Primary: Progression-free Survival (PFS)

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    End point title
    Progression-free Survival (PFS) [1]
    End point description
    PFS is a measure of the amount of time from randomization to the first documented disease progression (assessed by an independent radiology review Committee) or participant death, whichever occurs first
    End point type
    Primary
    End point timeframe
    From randomization (Cycle 1 Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)
    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: insufficient data were collected for this analysis
    End point values
    Dalotuzumab + irinotecan Cetuximab + irinotecan
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - Due to early termination of study, insufficient data were collected for this endpoint.
    [3] - Due to early termination of study, insufficient data were collected for this endpoint.
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    Objective Response Rate (ORR)
    End point description
    ORR will be based on the number of participants achieving a complete response (CR) or partial response (PR) during the course of the study using enhanced Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Confirmation of response is not required.
    End point type
    Secondary
    End point timeframe
    From randomization (Cycle 1 Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)
    End point values
    Dalotuzumab + irinotecan Cetuximab + irinotecan
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Percentage of Participants
    Notes
    [4] - Due to early termination of study, insufficient data were collected for this endpoint.
    [5] - Due to early termination of study, insufficient data were collected for this endpoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening through 30 days following the last dose of study treatment.
    Adverse event reporting additional description
    AE additional description
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Cetuximab + irinotecan
    Reporting group description
    -

    Reporting group title
    Dalotuzumab + irinotecan
    Reporting group description
    -

    Serious adverse events
    Cetuximab + irinotecan Dalotuzumab + irinotecan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (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
    Dyspnoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (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
    Bursitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (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
    Cellulitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Cetuximab + irinotecan Dalotuzumab + irinotecan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    6 / 6 (100.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    4
    6
    Catheter site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    2
    Mucosal inflammation
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    5
    Dyspnoea
         subjects affected / exposed
    2 / 5 (40.00%)
    3 / 6 (50.00%)
         occurrences all number
    2
    5
    Epistaxis
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    2
    Hypoxia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Laryngeal pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Throat irritation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    3
    2
    Platelet count decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Protein urine present
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Circadian rhythm sleep disorder
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Dysgeusia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Neuropathy peripheral
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 6 (33.33%)
         occurrences all number
    3
    2
    Lymphadenopathy
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Vertigo
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Eye pruritus
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    2 / 5 (40.00%)
    3 / 6 (50.00%)
         occurrences all number
    2
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Cheilitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 6 (16.67%)
         occurrences all number
    4
    1
    Diarrhoea
         subjects affected / exposed
    4 / 5 (80.00%)
    6 / 6 (100.00%)
         occurrences all number
    18
    23
    Dry mouth
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    6
    Epigastric discomfort
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Gingival oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    4 / 5 (80.00%)
    3 / 6 (50.00%)
         occurrences all number
    9
    7
    Oral pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    3 / 5 (60.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Toothache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 5 (40.00%)
    3 / 6 (50.00%)
         occurrences all number
    5
    6
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Alopecia
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 6 (33.33%)
         occurrences all number
    2
    3
    Dermatitis acneiform
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Nail disorder
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    4 / 5 (80.00%)
    1 / 6 (16.67%)
         occurrences all number
    6
    1
    Skin fissures
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 6 (16.67%)
         occurrences all number
    6
    1
    Skin lesion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Skin mass
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Polyuria
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Renal failure acute
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    2
    Back pain
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 6 (50.00%)
         occurrences all number
    1
    4
    Bone erosion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    3
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    4
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Candida infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gingival abscess
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    3
    Paronychia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Rhinitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 5 (80.00%)
    4 / 6 (66.67%)
         occurrences all number
    5
    16
    Dehydration
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    3
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2012
    Amendment 3 was done in response to differences in standards for management of cetuximab and irinotecan pre-medications between the United States and other countries – flexible language was added to allow Investigators to meet institutional and Regulatory guidelines. Product inserts were removed from the protocol to avoid confusion and allow each country to use their country-specific circular.
    28 Feb 2013
    Amendment 4 added an additional interim analysis to evaluate tumor response at 6 weeks; the effect of treatment on changes in tumor volume at 6 weeks was to be the basis for a decision on whether or not to continue to the next planned interim analysis or to stop the study.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Oct 2013
    The study did not meet target enrollment and was terminated for business reasons.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study did not meet target enrollment and was terminated for business reasons; insufficient data were collected for efficacy analyses. Safety data are reported.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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