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    Clinical Trial Results:
    A perioperative, single-arm multicenter Phase II academic trial to investigate the efficacy and safety of panitumumab in combination with irinotecan/5-fluorouracil/leucovorin (FOLFIRI) in patients with previously untreated, wild-type RAS, potentially resectable colorectal cancer liver metastases

    Summary
    EudraCT number
    		 2012-000265-20
    Trial protocol
    		 AT  
    Global end of trial date
    15 May 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Sep 2023
    First version publication date
    21 Oct 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Inclusion of follow-up data endpoints; update secondary endpoints, timepoint of analysis and adverse events

    Trial information

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    Trial identification
    Sponsor protocol code
    LM02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Amgen Identifier: ISS 20109160
    Sponsors
    Sponsor organisation name
    ABCSG (Austrian Breast & Colorectal Cancer Study Group)
    Sponsor organisation address
    Nußdorfer Platz 8/12, Vienna, Austria, 1190
    Public contact
    Trial Office, ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 14089230, info@abcsg.at
    Scientific contact
    Prof. Josef Thaler (Coordinating Investigator), ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 14089230, info@abcsg.at
    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 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of perioperative treatment including panitumumab and FOLFIRI as first line therapy for mCRC in subjects with potentially resectable liver metastases expressing wild-type RAS
    Protection of trial subjects
    The study specific patient information and informed consent form included language to encourage study participants to reach out to the Study Doctor / Study Team in case they have any questions, concerns or doubts. Section 14 specifically referenced a 24/7 contact person to reach out to and the ICF contained a reference to the local ombudsman / patient advocacy. A dedicated DMC was established to ensure patient safety throughout the trial and any safety requests could be addressed to the DMC members for their expertise and input, always considering patient safety and well-being in their decisions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    16
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Single-arm study with patient registration where study sites provided registration form to ABCSG via fax and a study specific identifier was assigned by ABCSG and returned to study sites in completed form.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 36
    Number of subjects completed
    		 36

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Panitumumab + FOLFIRI
    Arm description
    		 Panitumumab in combination with irinotecan/5-fluorouracil/leucovorin (FOLFIRI)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Panitumumab (Vectibix®) (IMP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg; totally 24 weeks before and after the surgery

    Investigational medicinal product name
    Irinotecan (NIMP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    180 mg/m2; 4 cycles (neoadjuvant) and 8 cycles (adjuvant) (1 cycle=2 weeks)

    Investigational medicinal product name
    5-fluorouracil (NIMP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    daily 2800 mg/ml (1x 400 (d1; iv bolus) followed by 2400 (over 46 hours iv infusion every 2 weeks); 4 cycles (neoadjuvant) and 8 cycles (adjuvant) (1 cycle = 2 weeks)

    Investigational medicinal product name
    Folinic acid (Leucovorin) (NIMP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for parenteral use
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m2; 4 cyles (neoadjuvant) and 8 cycles (adjuvant) (1 cycle = 2 weeks)

    Number of subjects in period 1
    		Panitumumab + FOLFIRI
    Started
    36
    Completed
    20
    Not completed
    16
         Adverse event, serious fatal
    3
         Death from other reason
    2
         Consent withdrawn by subject
    5
         Death from primary carcinoma
    5
         Missing informed consent
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Panitumumab + FOLFIRI
    Reporting group description
    		 Panitumumab in combination with irinotecan/5-fluorouracil/leucovorin (FOLFIRI)

    Reporting group values
    		 Panitumumab + FOLFIRI Total
    Number of subjects
    		 36 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 20 20
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (32 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 28 28
        Missing
    		 1 1
    ECOG Performance Status
    Units: Subjects
        '0'
    		 29 29
        '1'
    		 6 6
        Missing
    		 1 1
    T-stage
    Units: Subjects
        T1
    		 1 1
        T2
    		 5 5
        T3
    		 21 21
        TX
    		 6 6
        Missing
    		 3 3
    N-stage
    Units: Subjects
        N0
    		 11 11
        N1
    		 8 8
        N2
    		 5 5
        NX
    		 8 8
        Missing
    		 4 4
    Primary tumor location
    Units: Subjects
        Colon
    		 19 19
        Rectum
    		 10 10
        Rectum and Colon
    		 5 5
        Other
    		 1 1
        Missing
    		 1 1
    Prior chemotherapy
    Units: Subjects
        yes
    		 7 7
        no
    		 28 28
        Missing
    		 1 1
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled patients with signed informed consent.

    Subject analysis sets values
    		 ITT
    Number of subjects
    35
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    16
        From 65-84 years
    19
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    66 (32 to 81)
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    28
        Missing
    0
    ECOG Performance Status
    Units: Subjects
        '0'
    29
        '1'
    6
        Missing
    0
    T-stage
    Units: Subjects
        T1
    1
        T2
    5
        T3
    21
        TX
    6
        Missing
    2
    N-stage
    Units: Subjects
        N0
    11
        N1
    8
        N2
    5
        NX
    8
        Missing
    3
    Primary tumor location
    Units: Subjects
        Colon
    19
        Rectum
    10
        Rectum and Colon
    5
        Other
    1
        Missing
    0
    Prior chemotherapy
    Units: Subjects
        yes
    7
        no
    28
        Missing
    0

    End points

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    End points reporting groups
    Reporting group title
    Panitumumab + FOLFIRI
    Reporting group description
    		 Panitumumab in combination with irinotecan/5-fluorouracil/leucovorin (FOLFIRI)

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled patients with signed informed consent.

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    Objective response rate (ORR) is evaluated using RECIST (1.1), measured by multislice 3-phase CT and is based on target and non-target lesions. Missing radiological response evaluation is evaluated as no objective response. ORR is defined as the proportion of patients with overall response of CR (complete response) or PR (partial response). The number of patients with objective response, as well as the estimated rate and the exact 95% confidence intervals are given.
    End point type
    Primary
    End point timeframe
    After neoadjuvant therapy (4 cycles)
    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: It is not possible in EudraCT to enter statistical analysis for single-arm studies - the estimated rate with the 95% confidence interval was therefore included in the description.
    End point values
    		 ITT
    Number of subjects analysed
    35 [2]
    Units: Subjects
        yes
    23
        no
    12
    Notes
    [2] - The estimated ORR is 0.66 with a two-sided 95% confidence interval (CI) of [0.48, 0.81].
    No statistical analyses for this end point

    Primary: Diarrhoea Grade 3/4

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    End point title
    		 Diarrhoea Grade 3/4 [3]
    End point description
    The safety primary endpoint is to assess the rate of patients with at least one diarrhoea event of grade 3 or 4 (Common Terminology Criteria for Adverse Events (CTCAE) v4.0). For patients without early end of therapy/study before neoadjuvant staging: if diarrhoea documentation for a neoadjuvant therapy visit is missing and there is no prior documented diarrhoea grade III/IV adverse event -- no diarrhoea grade III/IV is assumed for that cycle. For patients with early end of treatment/study before neoadjuvant staging visit: o no diarrhoea Grade III/IV is assumed if the patient died without disease o a diarrhoea Grade III/IV is assumed if the patient had an early end of therapy due to disease progression, due to other (no diarrhoea) toxicity or if the patient withdraws Informed consent during neoadjuvant therapy The number of patients with Diarrhoea Grade 3/4 is given.
    End point type
    Primary
    End point timeframe
    During 4 cycles of neoadjuvant therapy
    Notes
    [3] - 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: Analysis is descriptive only.
    End point values
    		 ITT
    Number of subjects analysed
    35
    Units: Subjects
        yes
    5
        no
    30
    No statistical analyses for this end point

    Secondary: ORR in patients without liver tissue damage

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    End point title
    		 ORR in patients without liver tissue damage
    End point description
    Objective response rate (ORR) is evaluated using RECIST (1.1), measured by multislice 3-phase CT and is based on target and non-target lesions. Missing radiological response evaluation is evaluated as no objective response. ORR is defined as the proportion of patients with overall response of CR (complete response) or PR (partial response). The number of patients with objective response in those without liver tissue damage, as well as the number of patients with liver tissue damage are given. Presence of liver tissue damage is defined as chemotherapy-associated steatohepatitis (CASH) or chemotherapyassociated liver injuries. CASH is evaluated through NAFLD activity score (NAS) and Fibrosis score. A NAS score of greater or equal to 3 with or without any fibrosis are diagnostic for CASH. Liver injuries are defined as presence of CASH, sinusoidal obstruction syndrome (SOS) or nodular regenerative hyperplasia (NRH). No liver tissue damage is assumed if neither CASH nor SOS nor NRH occurs.
    End point type
    Secondary
    End point timeframe
    After neoadjuvant therapy (4 cycles)
    End point values
    		 ITT
    Number of subjects analysed
    5 [4]
    Units: Subjects
        yes
    5
        no
    0
    Notes
    [4] - 5 patients didn't have liver damage (CASH), 13 patients had; 17 had missing documentation
    No statistical analyses for this end point

    Secondary: Resection rate

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    End point title
    		 Resection rate
    End point description
    All liver lesions resected after final liver metastases surgery are evaluated. Liver lesions with resection margin status R2 (macroscopic residual tumor) are not considered as resected, while RX/R0/R1 are considered as resected. The liver resection rate is evaluated through the number of patients with documented surgery of liver metastases and with all liver lesions resected after final liver metastases surgery. The number of patients with liver resection, as well as the estimated rate and the exact 95% confidence intervals are given.
    End point type
    Secondary
    End point timeframe
    After neoadjuvant chemotherapy
    End point values
    		 ITT
    Number of subjects analysed
    35 [5]
    Units: Subjects
        yes
    29
        no
    6
    Notes
    [5] - The estimated resection rate is 0.83 with a two-sided 95% confidence interval (CI) of [0.66, 0.93].
    No statistical analyses for this end point

    Secondary: Perioperative morbidity and mortality

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    End point title
    		 Perioperative morbidity and mortality
    End point description
    Perioperative morbidity is measured by Dindo classification during post-operative stay. Perioperative mortality is defined as any death, regardless of cause, occurring within 30 days after surgery. The number of patients with perioperative morbidity and mortality is given in the different grade categories.
    End point type
    Secondary
    End point timeframe
    During post-operative stay
    End point values
    		 ITT
    Number of subjects analysed
    28 [6]
    Units: Subjects
        Grade I
    22
        Grade II
    3
        Grade IIIb
    1
        Grade IVa
    1
        Grade V
    1
    Notes
    [6] - From 29 patients with surgery of liver metastases, classification was documented for 28 patients.
    No statistical analyses for this end point

    Secondary: Complete pathological response

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    End point title
    		 Complete pathological response
    End point description
    Pathological response of neoadjuvant chemotherapy is measured by tumor regression grade, a histological tumor response assessment of hepatic colorectal metastases established by Rubbia-Brandt et al. Complete pathological response is defined as a tumor with Rubbia-Brandt tumor regression grade (TRG) 1. The number of patients with complete pathological response is reported.
    End point type
    Secondary
    End point timeframe
    At surgery
    End point values
    		 ITT
    Number of subjects analysed
    25 [7]
    Units: Subjects
        yes
    2
        no
    23
    Notes
    [7] - For 25 of the 29 patients who underwent surgery of liver metastases TRG was evaluable.
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    Progression-free survival (PFS) was defined as the time from registration date to the date of first observed progression (defined as occurrence of new secondary carcinoma or death of any cause whichever comes first). Patients who had no progression and did not die prior to the analysis data cut-off date were censored at their last known progression free date. Survival rate estimates at 24 months with 2-sided 95% confidence intervals were calculated by Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    end of study
    End point values
    		 ITT
    Number of subjects analysed
    35
    Units: percent
        number (confidence interval 95%)
    30.8 (16.2 to 46.7)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival (OS) was defined as the time from registration date to the date of death (of any cause). Patients who did not die prior to the analysis data cut-off date were censored at their last contact date. Survival rate estimates at 24 months with 2-sided 95% confidence intervals were calculated by Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    end of study
    End point values
    		 ITT
    Number of subjects analysed
    35
    Units: percent
        number (confidence interval 95%)
    73.3 (54.8 to 85.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    (S)AE reporting was mandatory from the date of informed consent form signature (i.e., screening phase) until 42 days after the last dose of neoadjuvant study treatment.
    Adverse event reporting additional description
    Screening Phase: only AEs deemed to be serious (SAEs) and related to protocol mandated and not routinely performed procedures have to be reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Reporting group description
    		 -

    Reporting group title
    Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A)
    Reporting group description
    		 -

    Serious adverse events
    		 Pertuzumab+Trastuzumab+Epirubicin (Arm B) Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 29 (20.69%)
    5 / 29 (17.24%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
    Additional description: Infusion related reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiomyopathy
    Additional description: Cardiomyopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
    Additional description: Febrile neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
    Additional description: General physical health deterioration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Alveolar osteitis
    Additional description: Alveolar osteitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
    Additional description: COVID-19
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
    Additional description: Febrile infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pertuzumab+Trastuzumab+Epirubicin (Arm B) Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 29 (100.00%)
    29 / 29 (100.00%)
    Vascular disorders
    Hypotension
    Additional description: Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Hot flush
    Additional description: Hot flush
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Hypertension
    Additional description: Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Thrombophlebitis
    Additional description: Thrombophlebitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
    Additional description: Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 29 (58.62%)
    14 / 29 (48.28%)
         occurrences all number
    35
    29
    Chills
    Additional description: Chills
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 29 (24.14%)
    7 / 29 (24.14%)
         occurrences all number
    7
    8
    Pyrexia
    Additional description: Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 29 (24.14%)
    5 / 29 (17.24%)
         occurrences all number
    8
    8
    Pain
    Additional description: Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Mucosal inflammation
    Additional description: Mucosal inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    5 / 29 (17.24%)
         occurrences all number
    6
    8
    Influenza like illness
    Additional description: Influenza like illness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Breast pain
    Additional description: Breast pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Vulvovaginal dryness
    Additional description: Vulvovaginal dryness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    4
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Epistaxis
    Additional description: Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Nasal dryness
    Additional description: Nasal dryness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    Rhinorrhoea
    Additional description: Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Psychiatric disorders
    Sleep disorder
    Additional description: Sleep disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Injury, poisoning and procedural complications
    Infusion related reaction
    Additional description: Infusion related reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    3
    2
    Nervous system disorders
    Dysgeusia
    Additional description: Dysgeusia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    1
    4
    Ageusia
    Additional description: Ageusia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Headache
    Additional description: Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 29 (27.59%)
    7 / 29 (24.14%)
         occurrences all number
    16
    7
    Paraesthesia
    Additional description: Paraesthesia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    2
    4
    Polyneuropathy
    Additional description: Polyneuropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    2
    5
    Taste disorder
    Additional description: Taste disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    5
    3
    Blood and lymphatic system disorders
    Neutropenia
    Additional description: Neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    6 / 29 (20.69%)
         occurrences all number
    7
    9
    Leukopenia
    Additional description: Leukopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    Anaemia
    Additional description: Anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
         occurrences all number
    4
    6
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    4
    10
    Eye disorders
    Visual impairment
    Additional description: Visual impairment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Dry eye
    Additional description: Dry eye
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Nausea
    Additional description: Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    20 / 29 (68.97%)
    20 / 29 (68.97%)
         occurrences all number
    45
    38
    Diarrhoea
    Additional description: Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 29 (62.07%)
    17 / 29 (58.62%)
         occurrences all number
    43
    42
    Constipation
    Additional description: Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 29 (27.59%)
    5 / 29 (17.24%)
         occurrences all number
    15
    9
    Abnormal faeces
    Additional description: Abnormal faeces
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
    Additional description: Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Stomatitis
    Additional description: Stomatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    Vomiting
    Additional description: Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    6
    4
    Dyspepsia
    Additional description: Dyspepsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    2 / 29 (6.90%)
         occurrences all number
    8
    2
    Hepatobiliary disorders
    Hypertransaminasaemia
    Additional description: Hypertransaminasaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    3
    2
    Skin and subcutaneous tissue disorders
    Nail disorder
    Additional description: Nail disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Pruritus
    Additional description: Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Intertrigo
    Additional description: Intertrigo
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    Eczema
    Additional description: Eczema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
         occurrences all number
    5
    0
    Alopecia
    Additional description: Alopecia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 29 (27.59%)
    12 / 29 (41.38%)
         occurrences all number
    10
    14
    Dry skin
    Additional description: Dry skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    4 / 29 (13.79%)
         occurrences all number
    5
    4
    Rash
    Additional description: Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    3 / 29 (10.34%)
         occurrences all number
    5
    3
    Renal and urinary disorders
    Dysuria
    Additional description: Dysuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Endocrine disorders
    Immune-mediated hyperthyroidism
    Additional description: Immune-mediated hyperthyroidism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 29 (17.24%)
         occurrences all number
    3
    5
    Pain in extremity
    Additional description: Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    Myalgia
    Additional description: Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    3
    3
    Muscle spasms
    Additional description: Muscle spasms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Back pain
    Additional description: Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    3
    3
    Infections and infestations
    Urinary tract infection
    Additional description: Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 29 (13.79%)
         occurrences all number
    2
    7
    Rhinitis
    Additional description: Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Respiratory tract infection
    Additional description: Respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Oral herpes
    Additional description: Oral herpes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    Nasopharyngitis
    Additional description: Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    1 / 29 (3.45%)
         occurrences all number
    5
    1
    Candida infection
    Additional description: Candida infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Decreased appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    6 / 29 (20.69%)
         occurrences all number
    6
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2013
    Approval for anti-EGFR therapy with Panitumuab was adapted for patients with wild-type RAS mCRC (without mutations in exon 2,3 and 4 of KAS and NRAS) which was reflected in the amendment, along with changes and clarifications in protocol definitions, endpoints, recruitment period (extension to 24 months), as well as administrative and technical updates and corrections (e.g. change of datamanagement system, typo corrections).

    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.
    Limitation of a nonrandomized design.
    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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