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    Clinical Trial Results:
    Panitumimab in combination with radiotherapy in patients with locally advanced RAS wildtype rectal cancer (clinical stages II and III)

    Summary
    EudraCT number
    		 2009-016782-28
    Trial protocol
    		 DE  
    Global end of trial date
    18 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2024
    First version publication date
    02 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GMIHO-009/2009/AG52
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01257360
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH
    Sponsor organisation address
    Almstadtstrasse 7, Berlin, Germany, 10119
    Public contact
    Medical Consulting, GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH, +49 35125933100, info@gmiho.de
    Scientific contact
    Medical Consulting, GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH, +49 35125933100, info@gmiho.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
    19 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to estimate the efficacy of panitumumab concurrent to radiotherapy in patients with wild-type RAS. The rate of pathological complete remissions will be compared to expectations derived from historical data.
    Protection of trial subjects
    A Data Safety and Monitoring Board will be established, consisting of two experts in medical oncology specializing in rectal cancer, and a statistical expert. The DSMB will receive regular information on safety results of the trial, namely a list of reported SAEs/SUSARs. A formal interim analysis report on safety, based on the data of the first ten patients enrolled, will be presented to the DSMB in order to decide on the feasibility and continuation of the study. Details on the work of the board will be described in a specific DSMB charter, to be jointly agreed upon by the board and the sponsor.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    54
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 18 February 2011 through 21 January 2015, a total of 59 patients were recruited at 5 study sites in Germany. 58 patients initially planned; plus 4 additional patients (RAS mutated in retesting), resulting in 62 patients.

    Pre-assignment
    Screening details
    		 5 patients were non-eligible; 4 due to RAS mutational status in the retesting; 1 due to ambiguous results in two independent KRAS tests at inclusion.

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

    Arms
    Arm title
    		 Conditioning therapy
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Vectibix
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6mg/kg BW q2w day -14, 1, 15, 29, 43 (d 43 optional if radiotherapy still ongoing)

    Number of subjects in period 1
    		Conditioning therapy
    Started
    54
    Completed
    54

    Baseline characteristics

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

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 54 54
    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)
    		 54 54
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 34 34
    Subject analysis sets

    Subject analysis set title
    ITT analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The primary endpoint of the study is the pCR rate, defined by the number of patients with a pCR finding divided by the number of patients recruited and having received at least one application of antitumor therapy.

    Subject analysis sets values
    		 ITT analysis
    Number of subjects
    54
    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)
    54
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    20
        Male
    34

    End points

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    End points reporting groups
    Reporting group title
    Conditioning therapy
    Reporting group description
    		 -

    Subject analysis set title
    ITT analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The primary endpoint of the study is the pCR rate, defined by the number of patients with a pCR finding divided by the number of patients recruited and having received at least one application of antitumor therapy.

    Primary: pathological complete response (pCR) rate

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    End point title
    		 pathological complete response (pCR) rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    20 weeks
    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: pCR rate (primary endpoint), and other rates are calculated, providing confidence intervals. All other parameters were evaluated in an explorative or descriptive manner, providing means, medians, interquartile and total ranges, standard deviations and/or confidence intervals, as appropriate for the respective data types.
    End point values
    		 ITT analysis
    Number of subjects analysed
    54
    Units: percent
        number (confidence interval 95%)
    3.7 (0.5 to 12.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    20 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: During radio-immuno therapy, the most common (above 5%) grad 3/4 toxicities were diarrhea (10%) and skin rash (acneiform) (20%). More then 90% of the patients experienced an acneiform skin rash (all grades), which fits well to the known data of panitumumab. During pre-operative therapy one patient died due to sudden death, which was assessed as not related to study treatment by the investigator.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2013
    Protocol Version 1.9 from 13.11.13 The aim of the amendment was to change the inclusion criteria as a consequence of the current change of the SmPC. Instead of KRAS wildtype, all patients should be RAS wildtype, as patients with KRAS exon 2 wildtype, but mutation in KRAS exon 3 or 4, or NRAS exons 2 to 4, do not benefit from Panitumumab therapy.

    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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