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    Clinical Trial Results:
    A Single Arm Phase II trial of BMN 673 for inoperable, advanced endometrial cancer with retrospective PTEN, MSI and MRE11 analysis.

    Summary
    EudraCT number
    		 2013-003469-32
    Trial protocol
    		 GB  
    Global end of trial date
    09 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2019
    First version publication date
    31 Oct 2019
    Other versions
    Summary report(s)
    		 Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    UCL/13/0045
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02127151
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower Street, London, United Kingdom,
    Public contact
    Cancer Research UK & UCL Cancer Trials Centre, University College London, ctc.enquiries@ucl.ac.uk
    Scientific contact
    Cancer Research UK & UCL Cancer Trials Centre, University College London, ctc.enquiries@ucl.ac.uk
    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
    09 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main aim of this trial is to show whether or not BMN 673 has therapeutic benefit in the treatment of inoperable, advanced, recurrent or metastatic endometrial cancer; specifically whether the drug extends the progression free survival of patients i.e. the length of time during and after the treatment that the patient lives with the cancer but it does not get significantly worse. This will be measured by looking at how many patients of the recruited patients are alive and progression free 6 months after their first dose of BMN 673.
    Protection of trial subjects
    No specific measure in place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2014
    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
    United Kingdom: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Trial abandoned during set-up by the sponsor (University College London) due to withdrawal of industry support. No sites activated and no patients entered the study, therefore no data/results are available. PLEASE NOTE: THE RESULTS SYSTEM DOES NOT ALLOW NUMBER OF PATIENTS TO BE ZERO, INSTEAD '1' WAS ADDED IN PATIENT SECTION TO ALLOW RESULT POSTING

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

    Arms
    Arm title
    		 Treatment Phase
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMN 673
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    250ug

    Number of subjects in period 1
    		Treatment Phase
    Started
    1
    Completed
    0
    Not completed
    1
         No patients actually enrolled on study
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment Phase
    Reporting group description
    		 -

    Primary: Progression free survival (PFS) rate at 6 months measured by RECIST v1.1.

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    End point title
    		 Progression free survival (PFS) rate at 6 months measured by RECIST v1.1. [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months from first BMN 673 dose.
    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: Trial abandoned during set-up by the sponsor (University College London) due to withdrawal of industry support. No sites activated and no patients entered the study, therefore no data/results are available. PLEASE NOTE: THE RESULTS POSTING SYSTEM DOES NOT ALLOW NUMBER OF PATIENTS TO BE ZERO, INSTEAD NUMBER OF PATIENTS WAS ADDED AS 1 IN ORDER TO ALLOW POSTING OF THE DATASET.
    End point values
    		 Treatment Phase
    Number of subjects analysed
    1 [2]
    Units: Patients
    0
    Notes
    [2] - No patients were actually enrolled in trial.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Dosing period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Treatment Phase
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    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: Trial abandoned during set-up by the sponsor (University College London) due to withdrawal of industry support. No sites activated and no patients entered the study, therefore no data/results are available. PLEASE NOTE: THE RESULTS POSTING SYSTEM DOES NOT ALLOW NUMBER OF PATIENTS TO BE ZERO, INSTEAD NUMBER OF PATIENTS WAS ADDED AS 1 IN ORDER TO ALLOW POSTING OF THE DATASET.

    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.
    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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