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    Clinical Trial Results:
    Phase II window of opportunity study of short term preoperative treatment with enzalutamide (alone or in combination with exemestane) in patients with primary breast cancer.

    Summary
    EudraCT number
    		 2014-002001-37
    Trial protocol
    		 GB   ES   DE  
    Global end of trial date
    31 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2021
    First version publication date
    15 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    009684QM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02676986
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Not applicable: Not applicable
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    Mile End Road, London, United Kingdom, E1 4NS
    Public contact
    CECM Trials Team, Queen Mary University of London, +44 2078828197, bci-cecmmonitoring@qmul.ac.uk
    Scientific contact
    CECM Trials Team, Queen Mary University of London, +44 2078828197, bci-cecmmonitoring@qmul.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
    23 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Determine the ability of enzalutamide, when taken alone or in combination with exemestane, to affect the growth of cancer cells in patients with newly diagnosed breast cancer.
    Protection of trial subjects
    The study design aimed to minimise potential risks. Eligibility criteria were selected to enhance the safety of patients in this trial and a number of exclusion criteria were specifically based on the known safety profiles of the study drug treatments. Short-term preoperative ‘window’ studies of 2-4 weeks treatment are a validated strategy to provide rapid and cost-efficient proof-of-concept for novel treatment approaches by assessing the direct effects of the study treatment on the tumour tissue.
    Background therapy
    		 None
    Evidence for comparator
    		 The ER+ve cohort focused on postmenopausal women with newly diagnosed, untreated ER+ve, invasive primary breast cancer. In this cohort, the trial evaluated the effects of preoperative therapy with enzalutamide plus exemestane relative to exemestane alone. It was established practice to treat ER-positive patients with endocrine therapy as soon as the diagnosis of breast cancer has been established, and several clinical trials had shown that two weeks preoperative therapy with an AI or tamoxifen markedly reduces proliferation as measured by Ki67 in human breast cancer. Experimental evidence furthermore suggests that short duration endocrine therapy shortly before and immediately after breast cancer surgery might improve long term outcome with no additional toxicity or resource implications. For TNBC, data for short-term preoperative therapy was less established due to the lack of a targeted treatment strategy with a favourable toxicity profile. In this context enzalutamide was offered as the only drug given to investigate the effects of enzalutamide alone.
    Actual start date of recruitment
    22 Sep 2015
    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
    Spain: 24
    Country: Number of subjects enrolled
    United Kingdom: 64
    Country: Number of subjects enrolled
    Germany: 124
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    219
    EEA total number of subjects
    212
    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)
    105
    From 65 to 84 years
    110
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 From September 2015 to November 2017, 194 patients with newly diagnosed, untreated ER+ve, invasive primary breast cancer were recruited and 27 patients were recruited to the AR+ve, triple negative breast cancer cohort. In total, 221 patients were enrolled but 219 patients received treatment and were therefore included in the result analysis.

    Pre-assignment
    Screening details
    		 The ER+ve cohort focused on postmenopausal women with newly diagnosed, untreated ER+ve, invasive primary breast cancer. The AR+ve, TNBC cohort focused on women with newly diagnosed, untreated, AR+ve, TNBC invasive primary breast cancer. All patients had to have been previously untreated, a tumour size over 1cm, ECOG performance status 0-2.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ER+ve Cohort Exemestane Only
    Arm description
    		 Patients were given 25mg/day of exemestane for a minimum of 15 days and a maximum of 29 days until patients either had definitive surgery or primary medical treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Exemestane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg in 1 tablet (25 mg)

    Arm title
    		 ER+ve Cohort Enzalutamide and Exemestane
    Arm description
    		 Patients were treated with 160mg/day of enzalutamide plus 50mg of exemestane for a minimum of 15 days and a maximum of 29 days before patients either had definitive surgery or primary medical treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Enzalutamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    160mg/day

    Investigational medicinal product name
    Exemestane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg in 2 tablets (25 mg each)

    Arm title
    		 AR+ve, TNBC
    Arm description
    		 The AR+ve, TNBC cohort included patients with newly diagnosed, untreated, AR+ve, TNBC invasive primary breast cancer. In this cohort, the trial evaluated the effects of preoperative therapy with enzalutamide alone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enzalutamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    160mg/day of enzalutamide

    Number of subjects in period 1
    		ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC
    Started
    63
    129
    27
    Completed
    59
    122
    26
    Not completed
    4
    7
    1
         Consent withdrawn by subject
    3
    1
    1
         Adverse event, non-fatal
    1
    4
    -
         Protocol deviation
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ER+ve Cohort Exemestane Only
    Reporting group description
    		 Patients were given 25mg/day of exemestane for a minimum of 15 days and a maximum of 29 days until patients either had definitive surgery or primary medical treatment.

    Reporting group title
    ER+ve Cohort Enzalutamide and Exemestane
    Reporting group description
    		 Patients were treated with 160mg/day of enzalutamide plus 50mg of exemestane for a minimum of 15 days and a maximum of 29 days before patients either had definitive surgery or primary medical treatment.

    Reporting group title
    AR+ve, TNBC
    Reporting group description
    		 The AR+ve, TNBC cohort included patients with newly diagnosed, untreated, AR+ve, TNBC invasive primary breast cancer. In this cohort, the trial evaluated the effects of preoperative therapy with enzalutamide alone.

    Reporting group values
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC Total
    Number of subjects
    		 63 129 27 219
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 28 61 16 105
        From 65-84 years
    		 34 65 11 110
        85 years and over
    		 1 3 0 4
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (52 to 86) 65 (49 to 87) 60 (44 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 63 129 27 219
        Male
    		 0 0 0 0
    Tumour Grade
    Units: Subjects
        Grade 1
    		 7 18 1 26
        Grade 2
    		 46 87 12 145
        Grade 3
    		 10 24 14 48
    ECOG Performance Status
    Units: Subjects
        0 - Fully active
    		 58 119 26 203
        1 - Ambulatory
    		 5 10 1 16

    End points

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    End points reporting groups
    Reporting group title
    ER+ve Cohort Exemestane Only
    Reporting group description
    		 Patients were given 25mg/day of exemestane for a minimum of 15 days and a maximum of 29 days until patients either had definitive surgery or primary medical treatment.

    Reporting group title
    ER+ve Cohort Enzalutamide and Exemestane
    Reporting group description
    		 Patients were treated with 160mg/day of enzalutamide plus 50mg of exemestane for a minimum of 15 days and a maximum of 29 days before patients either had definitive surgery or primary medical treatment.

    Reporting group title
    AR+ve, TNBC
    Reporting group description
    		 The AR+ve, TNBC cohort included patients with newly diagnosed, untreated, AR+ve, TNBC invasive primary breast cancer. In this cohort, the trial evaluated the effects of preoperative therapy with enzalutamide alone.

    Primary: Geometric mean change in Ki67 expression in ER+ve Cohort

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    End point title
    		 Geometric mean change in Ki67 expression in ER+ve Cohort [1]
    End point description
    Mean change in Ki67 expression is primary endpoint for the ER+ cohort only. The difference in geometric mean change (end of treatment – pre-treatment) in Ki67 expression between the two treatment groups (Mean ΔKi67). Geometric mean Ki67 suppression is calculated as 1 minus the back-transformation of the arithmetic mean of [ln(Ki67post) – ln(Ki67pre)].
    End point type
    Primary
    End point timeframe
    Baseline to end of treatment
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Comparison not applicable for single arm cohort
    End point values
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane
    Number of subjects analysed
    48
    93
    Units: Ki67 expression
    geometric mean (confidence interval 95%)
        Geometric mean Ki67 suppression (%)
    55.9 (47.1 to 63.2)
    59.8 (53.1 to 65.6)
    Statistical analysis title
    		 Relative Risk
    Comparison groups
    ER+ve Cohort Exemestane Only v ER+ve Cohort Enzalutamide and Exemestane
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.771
    Method
    		 t-test, 1-sided
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.17

    Primary: AR+ve TNBC individual anti-proliferative response

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    End point title
    		 AR+ve TNBC individual anti-proliferative response [2] [3]
    End point description
    Individual anti-proliferative response rate (RRΔKi67), where response is defined as a ≥50% fall in Ki67 expression over the course of the study treatment.
    End point type
    Primary
    End point timeframe
    Baseline to end of treatment
    Notes
    [2] - 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: Comparisons not applicable as single arm cohort
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Comparisons not applicable as single arm cohort
    End point values
    		 AR+ve, TNBC
    Number of subjects analysed
    21
    Units: Response rate
    number (confidence interval 95%)
        RRΔKi67 response rate
    4.8 (0.1 to 23.8)
    No statistical analyses for this end point

    Secondary: Geometric mean Ki67 expression at the end of study treatment

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    End point title
    		 Geometric mean Ki67 expression at the end of study treatment
    End point description
    ER+ve: The difference in geometric mean Ki67 expression at the end of study treatment (Mean Ki67post) between the two treatment groups. AR+ve: Geometric mean Ki67 expression at the end of study treatment (Mean Ki67post).
    End point type
    Secondary
    End point timeframe
    End of treatment
    End point values
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC
    Number of subjects analysed
    48
    93
    21
    Units: Ki67 expression
        geometric mean (confidence interval 95%)
    5.9 (4.6 to 7.5)
    5.7 (4.7 to 6.8)
    19.8 (13.2 to 29.8)
    No statistical analyses for this end point

    Secondary: Individual end-of treatment anti-proliferative response (RRKi67-Post)

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    End point title
    		 Individual end-of treatment anti-proliferative response (RRKi67-Post)
    End point description
    ER+ve: Individual end of treatment anti-proliferative response rate (RRKi67-post) in both treatment groups, where response is defined as the natural logarithm of percentage positive Ki67 of less than 1 at the end of study treatment; the analysis will be limited to patients with pre-treatment ln(%Ki67)≥1. AR+ve: Individual end of treatment anti-proliferative response rate (RRKi67-post), where response is defined as the natural logarithm of percentage positive Ki67 of less than 1 at the end of study treatment; the analysis will be limited to patients with pre-treatment ln(%Ki67)≥1.
    End point type
    Secondary
    End point timeframe
    End of treatment
    End point values
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC
    Number of subjects analysed
    48
    93
    21
    Units: Ki67 response rate
        number (confidence interval 95%)
    14.6 (6.1 to 27.8)
    21.5 (13.7 to 31.2)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Individual anti-proliferative response (RRΔKi67) in ER+ve cohort

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    End point title
    		 Individual anti-proliferative response (RRΔKi67) in ER+ve cohort [4]
    End point description
    ER+ve: Individual anti-proliferative response rate (RRΔKi67), where response is defined as a ≥50% fall in Ki67 expression over the course of the study treatment in both treatment groups.
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Comparison not applicable for single arm cohort
    End point values
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane
    Number of subjects analysed
    48
    93
    Units: Anti proliferative response rate
    number (confidence interval 95%)
        anti-proliferative response (RRΔKi67)
    54.2 (39.2 to 68.6)
    63.4 (52.8 to 73.2)
    No statistical analyses for this end point

    Secondary: Geometric mean change in Caspase-3

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    End point title
    		 Geometric mean change in Caspase-3
    End point description
    ER+ve: The difference in geometric mean change (end of treatment – pre-treatment) in Caspase-3 between the two treatment groups (Mean ΔCaspase-3). AR+ve: Geometric mean change in Caspase-3 at the end of study treatment (Mean ΔCaspase-3).
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment
    End point values
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC
    Number of subjects analysed
    47
    92
    20
    Units: Caspase-3 expression
        geometric mean (confidence interval 95%)
    1.7 (-102.4 to 52.2)
    18.2 (-33.5 to 49.9)
    0.1 (-34.6 to 25.8)
    No statistical analyses for this end point

    Secondary: Individual apoptotic response (RRΔCaspase-3)

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    End point title
    		 Individual apoptotic response (RRΔCaspase-3)
    End point description
    ER+ve: Individual apoptotic response rate (RRΔCaspase-3), where response is defined as a ≥50% increase in Caspase-3 over the course of the study treatment in both treatment groups. AR+ve: Individual apoptotic response rate (RRΔCaspase-3), where response is defined as a ≥50% increase in Caspase-3 over the course of the study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment
    End point values
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC
    Number of subjects analysed
    47
    92
    20
    Units: Response rate
        number (confidence interval 95%)
    29.8 (17.3 to 44.9)
    30.4 (21.3 to 40.9)
    20 (5.7 to 43.7)
    No statistical analyses for this end point

    Secondary: Geometric mean change in Ki67 expression in AR+ve cohort

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    End point title
    		 Geometric mean change in Ki67 expression in AR+ve cohort [5]
    End point description
    The difference in geometric mean change (end of treatment – pre-treatment) in Ki67 expression between the two treatment groups (Mean ΔKi67). Geometric mean Ki67 suppression is calculated as 1 minus the back-transformation of the arithmetic mean of [ln(Ki67post) – ln(Ki67pre)].
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Comparisons not applicable as single arm cohort
    End point values
    		 AR+ve, TNBC
    Number of subjects analysed
    21
    Units: Ki67 expression
        geometric mean (confidence interval 95%)
    7.5 (-8.2 to 21)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline until 30days after last day of treatment or study discontinuation/termination, whichever is later.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    ER+ve Cohort Exemestane Only
    Reporting group description
    		 Patients were given 25mg/day of exemestane for a minimum of 15 days and a maximum of 29 days until patients either had definitive surgery or primary medical treatment.

    Reporting group title
    ER+ve Cohort Enzalutamide and Exemestane
    Reporting group description
    		 Patients were treated with enzalutamide plus exemestane for a minimum of 15 days and a maximum of 29 days before patients either had definitive surgery or primary medical treatment.

    Reporting group title
    AR+ve, TNBC
    Reporting group description
    		 The AR+ve, TNBC cohort included patients with newly diagnosed, untreated, AR+ve, TNBC invasive primary breast cancer. In this cohort, the trial evaluated the effects of preoperative therapy with enzalutamide alone.

    Serious adverse events
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 129 (0.78%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Coma hypoglycemic
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 129 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Reduced general condition
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 129 (0.78%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 129 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ER+ve Cohort Exemestane Only ER+ve Cohort Enzalutamide and Exemestane AR+ve, TNBC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 63 (60.32%)
    63 / 129 (48.84%)
    15 / 27 (55.56%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    8 / 63 (12.70%)
    19 / 129 (14.73%)
    2 / 27 (7.41%)
         occurrences all number
    8
    20
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 63 (11.11%)
    9 / 129 (6.98%)
    2 / 27 (7.41%)
         occurrences all number
    7
    10
    2
    Dizziness
         subjects affected / exposed
    6 / 63 (9.52%)
    2 / 129 (1.55%)
    3 / 27 (11.11%)
         occurrences all number
    7
    3
    4
    Vertigo
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 129 (2.33%)
    1 / 27 (3.70%)
         occurrences all number
    4
    4
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 63 (6.35%)
    19 / 129 (14.73%)
    6 / 27 (22.22%)
         occurrences all number
    4
    22
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 63 (9.52%)
    11 / 129 (8.53%)
    3 / 27 (11.11%)
         occurrences all number
    6
    12
    4
    Diarrhoea
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 129 (3.10%)
    2 / 27 (7.41%)
         occurrences all number
    2
    5
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 129 (0.78%)
    3 / 27 (11.11%)
         occurrences all number
    2
    1
    3
    Exanthema subitum
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 129 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Mucositis
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 129 (1.55%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Sep 2015
    This amendment related to the addition of two sites.
    20 Nov 2015
    This amendment related to the addition of one site.
    08 Jan 2016
    This amendment related to the change of PI at one site.
    15 Apr 2016
    This amendment related to the addition of new sites.
    29 Jun 2016
    This amendment related to the addition of new sites.
    14 Nov 2019
    This amendment was to extend the date of end of trial.

    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 TNBC AR+ve cohort recruited 27/55 patients due to the funder not renewing stocks of existing IMP. The ER+ve cohort had completed recruitment, but the TNBC cohort was therefore stopped to recruitment early. The trial continued endpoint follow up.
    For support, Contact us.
    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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