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    Clinical Trial Results:
    Open-Label, Non-Randomized Study of U3-1287 in Combination with Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    2013-000104-42
    Trial protocol
    DE  
    Global end of trial date
    09 Apr 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Apr 2016
    First version publication date
    09 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U31287-A-U201E
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo Development Limited
    Sponsor organisation address
    Chiltern Place, Chalfont Park, Gerrards Cross, United Kingdom, SL9 0BG
    Public contact
    Clinical Trial Information, Daiichi Sankyo Development Limited, 44 1753 482800, info@dsd-eu.com
    Scientific contact
    Clinical Trial Information, Daiichi Sankyo Development Limited, 44 1753 482800, info@dsd-eu.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To allow continuation of study treatment for subjects who have demonstrated clinical benefit (stable disease or better) at the time of study closure for U31287-A-U201.
    Protection of trial subjects
    The study was conducted in compliance with ethical principles that have their origin in the Declarations of Helsinki the International Conference on Harmonisation (ICH) consolidated Guideline E6 for Good Clinical Practice (GCP) (CPMP/ICH/135/95), and applicable regulatory requirement(s): • USA FDA GCP guidelines; • USA Code of Federal Regulations Title 21, parts 11, 50, 54, 56, and 312; • EU Directive 2001/20/EC Implementation of good clinical practice in the conduct of clinical studies on medicinal products for human use; • EU Directive 2005/28/EC: Laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products; • Other applicable regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Nov 2013
    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
    Romania: 2
    Country: Number of subjects enrolled
    Germany: 2
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects who demonstrated clinical benefit (SD or better) at the time of study closure for U31287-A-U201, continued study treatment as last received in U31287-A-U201.

    Pre-assignment
    Screening details
    The open-label treatment assigned to each subject continuing under this protocol corresponded to the subject’s randomly assigned treatment received under protocol U31287-A-U201 with the exception of placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Erlotinib
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercial supplies of erlotinib were used. Erlotinib 150 mg or 100 mg tablet was self-administered PO QD. On the day of patritumab administration, erlotinib was taken after the infusion of patritumab was completed. Erlotinib was to be taken 1 h before or at least 2 h after meals.

    Arm title
    Erlotinib + Patritumab
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercial supplies of erlotinib were used. Erlotinib 150 mg or 100 mg tablet was self-administered PO QD. On the day of patritumab administration, erlotinib was taken after the infusion of patritumab was completed. Erlotinib was to be taken 1 h before or at least 2 h after meals.

    Investigational medicinal product name
    Patritumab
    Investigational medicinal product code
    U3-1287
    Other name
    AMG 888
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patritumab infusions were administered every 3 weeks. Patritumab was administered as a continuous intravenous infusion over 60 minutes (± 10 minutes). Infusion times could be extended to a maximum of 120 minutes for subjects unable to tolerate the 60 minute infusion.

    Number of subjects in period 1
    Erlotinib Erlotinib + Patritumab
    Started
    2
    2
    Completed
    0
    0
    Not completed
    2
    2
         Progressive Disease
    2
    2

    Baseline characteristics

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

    Reporting group values
    Treatment period Total
    Number of subjects
    4 4
    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)
    1 1
        From 65-84 years
    3 3
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    -

    Reporting group title
    Erlotinib + Patritumab
    Reporting group description
    -

    Primary: Safety - Adverse Events

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    End point title
    Safety - Adverse Events [1]
    End point description
    End point type
    Primary
    End point timeframe
    Until up to 60 days after end of treatment
    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: The primary objective of U31287-A-U201E was to allow continuation of study treatment for subjects who demonstrated clinical benefit (stable disease [SD] or better) at the time of study closure for U31287-A-U201. Safety data were collected but analysis was descriptive only due to small sample size.
    End point values
    Erlotinib Erlotinib + Patritumab
    Number of subjects analysed
    2
    2
    Units: Number of AEs
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from time of Informed Consent to the EOT visit assessment and up to 53 days after the last dose of U3-1287, or, if U3-1287 was discontinued earlier or if subject received erlotinib alone, up to 30 days after the last dose of erlotinib
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Erlotinib
    Reporting group description
    -

    Reporting group title
    Erlotinib + Patritumab
    Reporting group description
    -

    Serious adverse events
    Erlotinib Erlotinib + Patritumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Erlotinib Erlotinib + Patritumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    Although 1 subject was assigned the patritumab erlotinib combo on U201, they were on erlotinib and placebo at end of U201 and therefore only received erlotinib on U201E.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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