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    Clinical Trial Results:
    A Non-randomised Phase II Study to Evaluate the Optimal Uptake Time of 68Ga-OPS202 as a SSTR2 Positive PET Imaging Agent in Subjects with Newly Diagnosed Breast Cancer.

    Summary
    EudraCT number
    		 2018-000028-33
    Trial protocol
    		 AT  
    Global end of trial date
    09 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2020
    First version publication date
    02 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D-FR-01070-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03697551
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    65 quai Georges Gorse, Boulogne-Billancourt, France, 92100
    Public contact
    Medical Director, Ipsen Pharma, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Pharma, clinical.trials@ipsen.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
    06 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The co-primary objectives were to evaluate the percentage of women with newly diagnosed breast cancer who have somatostatin receptor subtype 2 (sstr2) positive lesions that were identified using gallium-68-satoreotide trizoxetan (68Ga-satoreotide trizoxetan; formerly known as 68Ga-OPS202); and to define the optimal positron emission tomography (PET) imaging time of 68Ga-satoreotide trizoxetan at 0.5, 1.0 and 2 hours post injection, based on detected lesions in adult women with sstr2 positive newly diagnosed early or advanced breast cancer.
    Protection of trial subjects
    The study was conducted in compliance with independent ethics committees, informed consent regulations, the Declaration of Helsinki and International Conference on Harmonisation Good Clinical Practice Guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2018
    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
    Austria: 4
    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)
    3
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Female subjects with newly diagnosed breast cancer who had a sstr2 positive lesion were recruited to this study from 22 October 2018, and the last subject last visit was on 6 February 2019. The study was terminated early on 9 August 2019.

    Pre-assignment
    Screening details
    		 Six subjects were screened and 4 subjects were eligible to receive 68Ga-satoreotide trizoxetan as a sstr2 positive PET imaging agent. The screening period was up to 14 days prior to the 68Ga-satoreotide trizoxetan administration on Day 1, with a follow-up visit at Day 14 for safety evaluation.

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

    Arms
    Arm title
    		 68Ga-Satoreotide Trizoxetan
    Arm description
    		 Subjects received a single dose of 68Ga-satoreotide trizoxetan on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-satoreotide trizoxetan
    Investigational medicinal product code
    Other name
    68Ga-OPS202; 68Ga-IPN01070
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    It was planned for subjects to receive a single dose of 68Ga-satoreotide trizoxetan which consisted of a peptide mass of up to 45 micrograms, with a radioactivity range of 150-200 megabecquerel (per protocol), administered as a slow intravenous bolus injected over 1 minute.

    Number of subjects in period 1
    		68Ga-Satoreotide Trizoxetan
    Started
    4
    Completed
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    68Ga-Satoreotide Trizoxetan
    Reporting group description
    		 Subjects received a single dose of 68Ga-satoreotide trizoxetan on Day 1.

    Reporting group values
    		 68Ga-Satoreotide Trizoxetan Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.8 ( 14.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    68Ga-Satoreotide Trizoxetan
    Reporting group description
    		 Subjects received a single dose of 68Ga-satoreotide trizoxetan on Day 1.

    Primary: Percentage of Subjects with Sufficiently Avid Lesion(s) Identified as sstr2 Positive Lesions (Co-Primary Endpoint)

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    End point title
    		 Percentage of Subjects with Sufficiently Avid Lesion(s) Identified as sstr2 Positive Lesions (Co-Primary Endpoint) [1]
    End point description
    The percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion using 68Ga-satoreotide trizoxetan was to be determined.
    End point type
    Primary
    End point timeframe
    At 0.5, 1.0 and 2.0 hours post injection on Day 1.
    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 study was stopped prematurely, prior to the generation of data sufficient to conduct formal statistical analyses. Consequently, statistical analyses as described in the protocol were not conducted.
    End point values
    		 68Ga-Satoreotide Trizoxetan
    Number of subjects analysed
    0 [2]
    Units: Percentage of subjects
    Notes
    [2] - No data was analysed for this endpoint due to early termination of the study.
    No statistical analyses for this end point

    Primary: Differences in the Number of Lesions Detected by 68Ga-satoreotide trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)

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    End point title
    		 Differences in the Number of Lesions Detected by 68Ga-satoreotide trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint) [3]
    End point description
    The differences in the number of lesions detected by 68Ga-satoreotide trizoxetan between the 3 PET acquisition timepoints, and reader interpretation was to be determined.
    End point type
    Primary
    End point timeframe
    0.5, 1.0 and 2.0 hours post injection on Day 1
    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: The study was stopped prematurely, prior to the generation of data sufficient to conduct formal statistical analyses. Consequently, statistical analyses as described in the protocol were not conducted.
    End point values
    		 68Ga-Satoreotide Trizoxetan
    Number of subjects analysed
    0 [4]
    Units: Number of lesions
    Notes
    [4] - No data was analysed for this endpoint due to early termination of the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Treatment emergent adverse events were monitored from Day 1 up to Day 14 (+/- 3 days) (2 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    68Ga-Satoreotide Trizoxetan
    Reporting group description
    		 Subjects received a single dose of 68Ga-satoreotide trizoxetan on Day 1.

    Serious adverse events
    		 68Ga-Satoreotide Trizoxetan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (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
    		 68Ga-Satoreotide Trizoxetan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (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: No serious and no non-serious adverse events were reported for this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2018
    To modify the restrictions on the minimum number of subjects per tumour stage, to update the version of the National Cancer Institute-Common Terminology Criteria for Adverse Events to be used, to update the pharmacovigilance contact details and to add instructions on spillage of the product, to make clarifications and to correct typographical errors.
    14 Sep 2018
    To correct a typo in the exclusion criterion which defined previous cancer of subjects not eligible for the study.

    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.
    The study was terminated early on 9 August 2019 due to recruitment challenges and the potential overlap with another Ipsen study, and not due to safety concerns.
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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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