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    Clinical Trial Results:
    Phase II trial to evaluate the efficacy and safety of chemoradiotherapy with 5-fluorouracil, mitomycin C and panitumumab as a treatment for squamous cell carcinoma of the anal canal

    Summary
    EudraCT number
    		 2010-018430-48
    Trial protocol
    		 ES  
    Global end of trial date
    16 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jul 2019
    First version publication date
    31 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GEMCAD-09-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01285778
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD)
    Sponsor organisation address
    Pau Alsina, 64-68, esc. B, entlo. 5ª, Barcelona, Spain, 08024
    Public contact
    Dr. Carlos Fernández Martos , Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD), 0034 934344412, secretaria@gemcad.org
    Scientific contact
    Dr. Carlos Fernández Martos , Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD), 0034 934344412, secretaria@gemcad.org
    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
    26 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the three-year disease-free survival rate in patients treated with 5-FU, mytomicin C and panitumumab concurrently with radiation therapy as treatment for squamous cell carcinoma of the anal canal (SCCAC).
    Protection of trial subjects
    For subjects who experienced unacceptable toxicity while in the study, one or more doses of panitumumab were suspended, reduced or delayed. Once the toxicity was solved, a limited number of attempts were made to re-increase the reduced doses of panitumumab. Escalations of doses higher than the initial dose of 6.0 mg / kg were not allowed.
    Background therapy
    		 None.
    Evidence for comparator
    		 Chemoradiotherapy with 5-FU and mitomycin C is the standard of care in Europe and U.S for the SCCAC. Panitumumab has been effective in other tumors and anti-EGFR treatment has demonstrated clinical activity in a single report of a refractory patient with SCCAC.
    Actual start date of recruitment
    24 Jan 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    41
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 58 patients were included in this study. All of them were included in the ITT, PP and safety populations. This national study included patients from 25 Spanish centers.

    Pre-assignment
    Screening details
    		 Key inclusion criteria: Male or female ≥18 years with histologically or cytologically confirmed SCACC; T2-T4 stage and any N stage (pelvic or inguinal) determined radiologically by MRI; ECOG performance status 0 to 2. All patients met the inclusion criteria.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable.

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Patients received treatment with panitumumab (Vectibix®, Amgen) 6 mg/kg intravenously (IV) on day 1 and every 2 weeks for 8 weeks. Panitumumab treatment was followed by 5-FU 1 000 mg/day by continuous IV infusion on days 1-4 and 29-32, and mitomycin C 10 mg/m2 IV on days 1 and 29. Radiotherapy was given on day 1-37 to a total dose of 45 Gy (1.8 Gy/fraction, 5 fractions per week) to the primary tumour and mesorectal, iliac and inguinal lymph nodes, plus a boost dose of 10-15 Gy to the primary tumour and affected lymph nodes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Panitumumab was administered by i.v. infusion. on day 1 and every 2 weeks for 8 weeks. The dose of panitumumab was 6 mg / kg. The total dose could be rounded up or down by no more than 10 mg. The dose of panitumumab was calculated from the subject's actual body weight at baseline (ie, cycle 1) and was not recalculated unless the changes in actual body weight were at least 10% from baseline. Panitumumab was diluted in a minimum of 100 mL of 0.9% sodium chloride apyrogenic solution, according to the USP / PhEur / JP (normal saline, provided by the center). The maximum concentration of the diluted solution that was administered by infusion should not exceed 10 mg / mL; if necessary, the volume of normal saline should be increased to 150 mL.

    Investigational medicinal product name
    Mitomycin C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received treatment with panitumumab (Vectibix®, Amgen) 6 mg/kg intravenously (IV) on day 1 and every 2 weeks for 8 weeks. Panitumumab treatment was followed by 5-FU 1 000 mg/day by continuous IV infusion on days 1-4 and 29-32, and mitomycin C 10 mg/m2 IV on days 1 and 29.

    Investigational medicinal product name
    5-fluorouracil (5-FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received treatment with panitumumab (Vectibix®, Amgen) 6 mg/kg intravenously (IV) on day 1 and every 2 weeks for 8 weeks. Panitumumab treatment was followed by 5-FU 1 000 mg/day by continuous IV infusion on days 1-4 and 29-32, and mitomycin C 10 mg/m2 IV on days 1 and 29.

    Investigational medicinal product name
    Radiotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Radiotherapy was administered on day 1-37 to a total dose of 45 Gy (1.8 Gy/fraction, 5 fractions per week) to the primary tumour and mesorectal, iliac and inguinal lymph nodes, plus a boost dose of 10-15 Gy to the primary tumour and affected lymph nodes.

    Number of subjects in period 1
    		Treatment
    Started
    58
    Completed
    58

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 58 58
    Age categorical
    Adults aged between 33 and 83 years.
    Units: Subjects
        Adults (18-64 years)
    		 41 41
        From 65-84 years
    		 17 17
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 59.2 (49.9 to 66.0) -
    Gender categorical
    Adult men and women
    Units: Subjects
        Female
    		 31 31
        Male
    		 27 27
    ECOG performance status
    Units: Subjects
        ECOG 0
    		 24 24
        ECOG 1
    		 33 33
        ECOG 2
    		 1 1
    TNM stage
    Units: Subjects
        TNM stage I
    		 0 0
        TNM stage II
    		 17 17
        TNM stage IIIA
    		 12 12
        TNM stage IIIB
    		 27 27
        TNM stage NE
    		 2 2
    HIV positive
    13 patients for the HIV results were not evaluated.
    Units: Subjects
        HIV positive
    		 4 4
        HIV negative
    		 41 41
        Not recorded
    		 13 13
    HPV positive
    12 patients for the HPV results were not evaluated.
    Units: Subjects
        HPV positive
    		 39 39
        HPV negative
    		 7 7
        Not recorded
    		 12 12
    Etnicity
    Units: Subjects
        Caucasian
    		 57 57
        Other
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Patients received treatment with panitumumab (Vectibix®, Amgen) 6 mg/kg intravenously (IV) on day 1 and every 2 weeks for 8 weeks. Panitumumab treatment was followed by 5-FU 1 000 mg/day by continuous IV infusion on days 1-4 and 29-32, and mitomycin C 10 mg/m2 IV on days 1 and 29. Radiotherapy was given on day 1-37 to a total dose of 45 Gy (1.8 Gy/fraction, 5 fractions per week) to the primary tumour and mesorectal, iliac and inguinal lymph nodes, plus a boost dose of 10-15 Gy to the primary tumour and affected lymph nodes.

    Primary: 3-year disease-free survival (DFS %)

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    End point title
    		 3-year disease-free survival (DFS %) [1]
    End point description
    Disease free survival was defined as number of months between the first treatment dose until the first treatment failure (defined as disease progression by MRI or CT, persistence of disease confirmed by biopsy performed at least 6 months after end of treatment, rescue surgery/colostomy by progression or death by progression).
    End point type
    Primary
    End point timeframe
    Percentage of subjects who are still alive and without disease after 3 years of follow-up.
    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: No statistical analysis was performed. There was only one arm treatment.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
    number (confidence interval 95%)
        36 months
    61.09 (47.13 to 72.40)
    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 was defined as the number of months between the first treatment dose until progression, rescue surgery/colostomy due to progression or death.
    End point type
    Secondary
    End point timeframe
    Time from the 1st dose of treatment to 3 years of progression.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
    number (confidence interval 95%)
        36 months
    57.54 (43.64 to 69.19)
    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 was defined as number of months between first treatment dose and death for any reason.
    End point type
    Secondary
    End point timeframe
    Overall survival at 3 years.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
    number (confidence interval 95%)
        36 months
    78.4 (65.1 to 87.1)
    No statistical analyses for this end point

    Secondary: Colostomy free survival (CFS %)

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    End point title
    		 Colostomy free survival (CFS %)
    End point description
    Colostomy free survival rate was defined as the number of patients alive and without a colostomy.
    End point type
    Secondary
    End point timeframe
    Percentage of subjects who are still alive and without colostomy after 2 years of follow-up.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
    number (confidence interval 95%)
        24 months
    68.11 (54.24 to 78.58)
    No statistical analyses for this end point

    Secondary: Locoregional failure (LRF %) free rate

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    End point title
    		 Locoregional failure (LRF %) free rate
    End point description
    LRF was defined as relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes.
    End point type
    Secondary
    End point timeframe
    Percentage of subjects who continue without local-regional relapses after 3 years of follow-up.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
    number (confidence interval 95%)
        36 months
    64.77 (50.87 to 75.65)
    No statistical analyses for this end point

    Secondary: Distant failure free rate (%)

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    End point title
    		 Distant failure free rate (%)
    End point description
    LRF was defined as relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes. All other relapses were considered distant failures.
    End point type
    Secondary
    End point timeframe
    Percentage of subjects who continue without relapses at distance after 3 years of follow-up.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
    number (confidence interval 95%)
        36 months
    92.98 (82.37 to 97.31)
    No statistical analyses for this end point

    Secondary: Complete response (CR) rate

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    End point title
    		 Complete response (CR) rate
    End point description
    Percentage of subjects who have reached a clinical and radiological CR. Response was evaluated clinically or radiologically according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1).
    End point type
    Secondary
    End point timeframe
    Patients who have reached at some point a clinical and/or radiological CR during the study.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
        number (confidence interval 95%)
    81.0 (69.8 to 92.2)
    No statistical analyses for this end point

    Secondary: Recurrence free survival (CFS %))

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    End point title
    		 Recurrence free survival (CFS %))
    End point description
    Recurrence free survival was defined as number of months between the first CR to the treatment until the first treatment failure (disease progression analysed by MRI or TC, rescue surgery/colostomy due to progression or death due to progression).
    End point type
    Secondary
    End point timeframe
    CFS at 2 years.
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: percent
    number (confidence interval 95%)
        24 months
    72.75 (56.20 to 83.89)
    No statistical analyses for this end point

    Other pre-specified: Analysis of duplication

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    End point title
    		 Analysis of duplication
    End point description
    Evaluation of the predictive molecular markers of response: the presence of duplications in 23 different genes in 27 patients with available samples.
    End point type
    Other pre-specified
    End point timeframe
    During the study
    End point values
    		 Treatment
    Number of subjects analysed
    27
    Units: frequency
    number (not applicable)
        EGFR
    26
        KRAS
    37
        BRAF
    0
        PIK3CA
    85
        PTEN
    26
        BRCA1
    4
        BRCA2
    22
        ERCC1
    48
        ERCC6
    4
        ERCC3
    4
        ERCC4
    26
        ERCC2
    37
        ERCC8
    33
        ERCC5
    19
        XRCC1
    30
        XRCC2
    59
        XRCC3
    4
        XRCC5
    4
        XRCC6
    26
        XRCC4
    30
        CCNA2 (cyclin a)
    19
        TP53
    15
        MDM2
    30
    No statistical analyses for this end point

    Other pre-specified: Analysis of deletions

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    End point title
    		 Analysis of deletions
    End point description
    Evaluation of the predictive molecular markers of response: the presence of deletions in 23 different genes in 27 patients with available samples.
    End point type
    Other pre-specified
    End point timeframe
    During the study
    End point values
    		 Treatment
    Number of subjects analysed
    27
    Units: frequency
    number (not applicable)
        EGFR
    7
        KRAS
    0
        BRAF
    15
        PIK3CA
    0
        PTEN
    15
        BRCA1
    59
        BRCA2
    33
        ERCC1
    4
        ERCC6
    74
        ERCC3
    30
        ERCC4
    7
        ERCC2
    7
        ERCC8
    15
        ERCC5
    22
        XRCC1
    0
        XRCC2
    7
        XRCC3
    33
        XRCC5
    37
        XRCC6
    7
        XRCC4
    15
        CCNA2 (cyclin a)
    19
        TP53
    48
        MDM2
    7
    No statistical analyses for this end point

    Other pre-specified: Analysis of single nucleotide polymorphisms (SNP)

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    End point title
    		 Analysis of single nucleotide polymorphisms (SNP)
    End point description
    Evaluation of the predictive molecular markers of response: the presence of SNP in 23 different genes in 27 patients with available samples.
    End point type
    Other pre-specified
    End point timeframe
    During the study
    End point values
    		 Treatment
    Number of subjects analysed
    58
    Units: frequency
    number (not applicable)
        EGFR
    0
        KRAS
    0
        BRAF
    4
        PIK3CA
    33
        PTEN
    4
        BRCA1
    15
        BRCA2
    7
        ERCC1
    0
        ERCC6
    7
        ERCC3
    7
        ERCC4
    4
        ERCC2
    4
        ERCC8
    0
        ERCC5
    4
        XRCC1
    0
        XRCC2
    0
        XRCC3
    0
        XRCC5
    0
        XRCC6
    4
        XRCC4
    7
        CCNA2 (cyclin a)
    0
        TP53
    4
        MDM2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The medically significant AEs that the investigator or the promoter considered related to the product under investigation were monitored until their resolution or until stabilization.
    Adverse event reporting additional description
    SAEs were collected and reported within 1 working day of the discovery or notification of the event if it appeared > 30 days after the last dose of the investigational product or after the end of the study and if it was believed that it was possibly related to the product under investigation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Patients received treatment with: 1,000 mg2 of 5-FU on days 1-4 and 29-32; 10 mg / m2 of mitomycin C on days 1 and 29; 6 mg / m2 of panitumumab on day 1 and every 2 weeks for 8 weeks; Radiotherapy: 45 Gy (1.8 Gy per fraction) in the regional and inguinal lymph nodes and the primary tumor, and then a 10-15 Gy boost in the primary tumor and affected lymph nodes.

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 58 (41.38%)
         number of deaths (all causes)
    13
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Weight decreased
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Platelet count decreased
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Enteritis
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Proctalgia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 58 (100.00%)
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    38 / 58 (65.52%)
         occurrences all number
    110
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Platelet count decreased
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    12
    Anaemia
         subjects affected / exposed
    16 / 58 (27.59%)
         occurrences all number
    35
    Leukopenia
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    13
    Lymphopenia
         subjects affected / exposed
    12 / 58 (20.69%)
         occurrences all number
    26
    Neutropenia
         subjects affected / exposed
    25 / 58 (43.10%)
         occurrences all number
    46
    Febrile neutropenia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    9
    Thrombocytopenia
         subjects affected / exposed
    14 / 58 (24.14%)
         occurrences all number
    19
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    33 / 58 (56.90%)
         occurrences all number
    54
    Pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Mucosal inflammation
         subjects affected / exposed
    25 / 58 (43.10%)
         occurrences all number
    38
    Pyrexia
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    13
    Xerosis
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    6
    Oedema peripheral
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Perineal pain
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    44 / 58 (75.86%)
         occurrences all number
    90
    Abdominal pain
         subjects affected / exposed
    14 / 58 (24.14%)
         occurrences all number
    18
    Abdominal pain upper
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Enteritis
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Perianal erythema
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    8
    Stomatitis
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    18
    Constipation
         subjects affected / exposed
    12 / 58 (20.69%)
         occurrences all number
    14
    Rectal haemorrhage
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Haemorrhoids
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    5
    Anal incontinence
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Anal inflammation
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    9
    Anorectal discomfort
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    18 / 58 (31.03%)
         occurrences all number
    22
    Odynophagia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Proctalgia
         subjects affected / exposed
    20 / 58 (34.48%)
         occurrences all number
    26
    Proctitis
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    8
    Rectal tenesmus
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    13 / 58 (22.41%)
         occurrences all number
    17
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    14
    Alopecia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Dermatitis
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    18
    Dermatitis acneiform
         subjects affected / exposed
    13 / 58 (22.41%)
         occurrences all number
    20
    Erythema
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    7
    Rash
         subjects affected / exposed
    31 / 58 (53.45%)
         occurrences all number
    52
    Skin fissures
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    5
    Dry skin
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    10
    Pruritus
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    14
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Urinary tract infection
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Pneumonia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    16 / 58 (27.59%)
         occurrences all number
    23
    Hypokalaemia
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    7
    Hypomagnesaemia
         subjects affected / exposed
    15 / 58 (25.86%)
         occurrences all number
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2010
    Through this amendment, the changes suggested by the Clinical Research Ethics Committees in the protocol were: the Subject Information Sheet, the Informed Consent Form, the Subject Information Sheet and the Informed Consent form of the optional study of molecular predictors. The changes to the protocol were as follows: the amount of panitumumab per vial was specified; and appendix E (panitumumab pharmaceutical guide) was modified in order to facilitate its comprehension.
    25 Jan 2011
    Through this amendment several typographical errors were amended in the protocol in order to facilitate its comprehension.

    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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