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    Clinical Trial Results:
    Panitumumab in combination with cisplatin/gemcitabine chemotherapy in patients with cholangiocarcinomas - a randomized clinical phase II study - PiCCA Study

    Summary
    EudraCT number
    		 2010-018850-11
    Trial protocol
    		 DE  
    Global end of trial date
    04 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2025
    First version publication date
    02 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MHH_CCA_AG54
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01320254
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hannover Medical School
    Sponsor organisation address
    Carl-Neuberg-Str. 1, Hannover, Germany, 30625
    Public contact
    Stabsstelle Zentrum für Klinische Studien, Hannover Medical School, EudraCT@mh-hannover.de
    Scientific contact
    Stabsstelle Zentrum für Klinische Studien, Hannover Medical School, EudraCT@mh-hannover.de
    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
    13 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of panitumumab plus the cisplatin/gemcitabine combination chemotherapy in k-ras wildtype in patients with cholangiocarcinoma / gallbladder carcinoma, compared to the historical data for the same chemotherapy, which are verified by a randomised control group without the antibody.
    Protection of trial subjects
    The clinical trial was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and with the standards of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). A continuous risk assessment was performed during the study.
    Background therapy
    		 Cisplatin and Gemcitabine are considered as chemotherapy backbone medication, as well as reference therapy. Cisplatin 25 mg/m² day 1 and day 8 / q3w Gemcitabine 1000mg/m² day 1 and day 8 / q3w
    Evidence for comparator
    		 Several phase II trials in CCA with a variety of cytostatic drugs incorporated have shown, that two-drug chemotherapy combinations typically lead to response rates of about 30%, ranging from 20% to 45%. With gemcitabine/cisplatin a median progression-free survival (PFS) of 8.5 months was achieved in a randomized phase III trial. This corresponds to a PFS rate of 61% after 6 months. Data on metastatic colorectal cancer suggest, that panitumumab is especially active in patients with KRAS wildtype tumors, which comprise about 60% of all colorectal carcinomas. A rather similar proportion has been described for CCA. However, the role of KRAS as a predictive marker for anti-EGFR-therapy in patients with cholangiocarcinomas and gallbladder-carcinomas is unknown.
    Actual start date of recruitment
    13 Apr 2011
    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: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    75
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited at 16 different centers all based in Germany. Eligibility was determined based upon the inclusion and exclusion criteria.

    Pre-assignment
    Screening details
    		 Eligibility was determined based upon the inclusion and exclusion criteria.

    Period 1
    Period 1 title
    overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 cisplatin/gemcitabine+panitumumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 25 mg/m² day 1 and day 8 / q3w

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000mg/m² day 1 and day 8 / q3w

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    9mg/kg BW q3w

    Arm title
    		 Arm B
    Arm description
    		 cisplatin/gemcitabine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 25 mg/m² day 1 and day 8 / q3w

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000mg/m² day 1 and day 8 / q3w

    Number of subjects in period 1
    		Arm A Arm B
    Started
    62
    28
    Completed
    17
    9
    Not completed
    45
    19
         died during follow-up
    45
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 cisplatin/gemcitabine+panitumumab

    Reporting group title
    Arm B
    Reporting group description
    		 cisplatin/gemcitabine

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 62 28 90
    Age categorical
    Units: Subjects
        <=40 Jahre
    		 1 1 2
        41-50 Jahre
    		 9 5 14
        51-60 Jahre
    		 15 10 25
        61-70 Jahre
    		 24 10 34
        >70 Jahre
    		 13 2 15
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.6 ( 11 ) 58.5 ( 10.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 26 14 40
        Male
    		 36 14 50
    localisation of tumor
    Units: Subjects
        Cholangicarcinoma
    		 50 25 75
        gall bladder carcinoma
    		 12 3 15

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 cisplatin/gemcitabine+panitumumab

    Reporting group title
    Arm B
    Reporting group description
    		 cisplatin/gemcitabine

    Primary: progression free survival rate after 6 months

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    End point title
    		 progression free survival rate after 6 months
    End point description
    The primary endpoint of the study is the progression-free survival rate after 6 months, based on the ITT population. The progression-free survival rate at six months is defined as the number of patients recorded to be free of progression (according to RECIST) at this time point, divided by the number of patients randomized to the respective arm
    End point type
    Primary
    End point timeframe
    6 months follow-up
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    59
    26
    Units: progression free survival rate
        number (confidence interval 95%)
    54 (41 to 67)
    73 (52 to 88)
    Statistical analysis title
    		 Progression free survivalt at 6 months
    Statistical analysis description
    difference of progression free survival at 6 months between treatment and comparison group
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.319
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Reporting of (S)AEs commences at subject enrolment into the study until the EOT Visit or 30 days after the last dose of IMP.
    Adverse event reporting additional description
    Evaluation of safety criteria is covered by documentation and reporting of adverse events and serious adverse events throughout study therapy, according to NCI CTCAE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    ArmA
    Reporting group description
    		 Cisplatin/Gemcitabin + Panitumumab

    Reporting group title
    ArmB
    Reporting group description
    		 Cisplatin/Gemcitabin

    Serious adverse events
    		 ArmA ArmB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 59 (11.86%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    7
    0
         number of deaths resulting from adverse events
    7
    0
    Cardiac disorders
    subcutaneous myocardial infarction
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Tumor progression
         subjects affected / exposed
    6 / 59 (10.17%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 6
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ArmA ArmB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 59 (100.00%)
    26 / 26 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    4 / 59 (6.78%)
    3 / 26 (11.54%)
         occurrences all number
    4
    3
    Hematoma
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    Hypertension
         subjects affected / exposed
    3 / 59 (5.08%)
    2 / 26 (7.69%)
         occurrences all number
    3
    2
    Hypotension
         subjects affected / exposed
    5 / 59 (8.47%)
    2 / 26 (7.69%)
         occurrences all number
    5
    2
    Peripheral arterial ischemia
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Phlebitis
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Thrombosis/embolism (vascular accesss)
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Thrombosis/thrombus/ embolism
         subjects affected / exposed
    6 / 59 (10.17%)
    5 / 26 (19.23%)
         occurrences all number
    6
    5
    General disorders and administration site conditions
    Edema: head and neck
         subjects affected / exposed
    1 / 59 (1.69%)
    3 / 26 (11.54%)
         occurrences all number
    1
    3
    Edema: limb
         subjects affected / exposed
    13 / 59 (22.03%)
    7 / 26 (26.92%)
         occurrences all number
    13
    7
    Fatigue
         subjects affected / exposed
    44 / 59 (74.58%)
    21 / 26 (80.77%)
         occurrences all number
    44
    21
    Fever
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Fever (any cause)
         subjects affected / exposed
    16 / 59 (27.12%)
    3 / 26 (11.54%)
         occurrences all number
    16
    3
    Injection site reaction
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Mucositis
         subjects affected / exposed
    28 / 59 (47.46%)
    8 / 26 (30.77%)
         occurrences all number
    28
    8
    Pain
         subjects affected / exposed
    44 / 59 (74.58%)
    21 / 26 (80.77%)
         occurrences all number
    44
    21
    Rigors/chills
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    SIRS
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    Worsening of general condition
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    4 / 59 (6.78%)
    0 / 26 (0.00%)
         occurrences all number
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Airway obstruction
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    8 / 59 (13.56%)
    1 / 26 (3.85%)
         occurrences all number
    8
    1
    Dyspnea
         subjects affected / exposed
    13 / 59 (22.03%)
    4 / 26 (15.38%)
         occurrences all number
    13
    4
    Hemorrhage pulmonary
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Pulmonary - Other
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 59 (10.17%)
    1 / 26 (3.85%)
         occurrences all number
    6
    1
    Mood alteration
         subjects affected / exposed
    4 / 59 (6.78%)
    3 / 26 (11.54%)
         occurrences all number
    4
    3
    Psychosis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Investigations
    ALT
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Alkaline phosphatase
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Bilirubin
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Creatinine
         subjects affected / exposed
    2 / 59 (3.39%)
    4 / 26 (15.38%)
         occurrences all number
    2
    4
    GFR
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    GGT
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Hemoglobin
         subjects affected / exposed
    48 / 59 (81.36%)
    22 / 26 (84.62%)
         occurrences all number
    48
    22
    Metabolic/Lab - Other
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Neutrophils
         subjects affected / exposed
    42 / 59 (71.19%)
    24 / 26 (92.31%)
         occurrences all number
    42
    24
    Weight gain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Weight loss
         subjects affected / exposed
    8 / 59 (13.56%)
    1 / 26 (3.85%)
         occurrences all number
    8
    1
    Injury, poisoning and procedural complications
    Burn
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Fracture
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Stricture, GI
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    Wound complication, non-infectious
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Smoke intoxication
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Fall (stumbled)
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Cardiac General - Other
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Cardiac ischemia/infarction
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Supraventricular arrhythmia
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 59 (13.56%)
    4 / 26 (15.38%)
         occurrences all number
    8
    4
    Neurology - Other
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Neuropathy-motor
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Neuropathy-sensory/ PNP
         subjects affected / exposed
    16 / 59 (27.12%)
    8 / 26 (30.77%)
         occurrences all number
    16
    8
    Seizure
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Syncope (fainting)
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    Taste alteration
         subjects affected / exposed
    5 / 59 (8.47%)
    4 / 26 (15.38%)
         occurrences all number
    5
    4
    Tremor
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Blood – Other (Specify)
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    4 / 59 (6.78%)
    0 / 26 (0.00%)
         occurrences all number
    4
    0
    Hemolysis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Leukocytes
         subjects affected / exposed
    43 / 59 (72.88%)
    26 / 26 (100.00%)
         occurrences all number
    43
    26
    Lymphopenia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Platelets
         subjects affected / exposed
    42 / 59 (71.19%)
    20 / 26 (76.92%)
         occurrences all number
    42
    20
    Thrombotic microangiopathy
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Ear and labyrinth disorders
    Auditory/Ear - Other (Specify)
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Hearing
         subjects affected / exposed
    0 / 59 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    0
    3
    Tinnitus
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Eyelid dysfunction
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Flashing lights
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Ocular - Other
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Ocular surface disease
         subjects affected / exposed
    5 / 59 (8.47%)
    0 / 26 (0.00%)
         occurrences all number
    5
    0
    Vitreous hemorrhage
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Watery eye
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    25 / 59 (42.37%)
    1 / 26 (3.85%)
         occurrences all number
    25
    1
    Diarrhea
         subjects affected / exposed
    21 / 59 (35.59%)
    2 / 26 (7.69%)
         occurrences all number
    21
    2
    Distension
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    Dysphagia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    GI - Other
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    Heartburn
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    Hemorrhage, GI
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Hemorrhage, GU
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    31 / 59 (52.54%)
    19 / 26 (73.08%)
         occurrences all number
    31
    19
    Teeth
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Ulcer, GI
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    17 / 59 (28.81%)
    6 / 26 (23.08%)
         occurrences all number
    17
    6
    Enteritis
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Fistula; GI
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Hemorrhoids
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Perforation GI
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatobiliary - Other
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Inflammation/ Infection of bile duct
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Liver dysfunction
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    40 / 59 (67.80%)
    4 / 26 (15.38%)
         occurrences all number
    40
    4
    Alopecia
         subjects affected / exposed
    12 / 59 (20.34%)
    5 / 26 (19.23%)
         occurrences all number
    12
    5
    Dry skin
         subjects affected / exposed
    40 / 59 (67.80%)
    0 / 26 (0.00%)
         occurrences all number
    40
    0
    Hand-foot syndrome
         subjects affected / exposed
    7 / 59 (11.86%)
    0 / 26 (0.00%)
         occurrences all number
    7
    0
    Nail changes
         subjects affected / exposed
    18 / 59 (30.51%)
    0 / 26 (0.00%)
         occurrences all number
    18
    0
    Petechiae
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Photosensitivity
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    23 / 59 (38.98%)
    0 / 26 (0.00%)
         occurrences all number
    23
    0
    Rash
         subjects affected / exposed
    34 / 59 (57.63%)
    5 / 26 (19.23%)
         occurrences all number
    34
    5
    Rhagades
         subjects affected / exposed
    12 / 59 (20.34%)
    1 / 26 (3.85%)
         occurrences all number
    12
    1
    Sweating
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Dermatology - other
         subjects affected / exposed
    5 / 59 (8.47%)
    0 / 26 (0.00%)
         occurrences all number
    5
    0
    Renal and urinary disorders
    Renal - Other
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Renal failure
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Urinary frequency
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    24 / 59 (40.68%)
    6 / 26 (23.08%)
         occurrences all number
    24
    6
    Infection (Skin)
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    7 / 59 (11.86%)
    1 / 26 (3.85%)
         occurrences all number
    7
    1
    Hypercalcemia
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    Hyperglycemia
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Hyperkalemia
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hypoalbuminemia
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Hypomagnesemia
         subjects affected / exposed
    9 / 59 (15.25%)
    2 / 26 (7.69%)
         occurrences all number
    9
    2
    Hyponatremia
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Diabetes
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 26 (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
    16 Jun 2011
    change of coordinating investigator
    06 Oct 2011
    changes to the central KRAS testing

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29413685
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