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    Clinical Trial Results:
    Study of Females Exposed to Eleclazine

    Summary
    EudraCT number
    		 2019-003958-86
    Trial protocol
    		 DK   IT   NL   FR  
    Global end of trial date
    31 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2024
    First version publication date
    31 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-356-5413
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    31 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to find out if any female participants had signs or symptoms potentially consistent with uterine cancer after eleclazine exposure.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2022
    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
    Netherlands: 2
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    United States: 46
    Country: Number of subjects enrolled
    New Zealand: 3
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    77
    EEA total number of subjects
    26
    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)
    62
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, Europe, New Zealand, the United Kingdom and Israel.

    Pre-assignment
    Screening details
    		 Participants who received eleclazine during prior clinical trials were enrolled in this study.

    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
    		 Eleclazine
    Arm description
    		 Female participants who received eleclazine tablets at a dose of 1 mg, 3 mg, 6 mg, 10 mg or 60 mg in previous Gilead-sponsored studies were enrolled in this study. Participants did not receive any treatment during this study. Participants were examined to see the signs or symptoms of uterine cancer.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eleclazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Number of subjects in period 1
    		Eleclazine
    Started
    77
    Completed
    68
    Not completed
    9
         Death
    8
         Investigator's discretion
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eleclazine
    Reporting group description
    		 Female participants who received eleclazine tablets at a dose of 1 mg, 3 mg, 6 mg, 10 mg or 60 mg in previous Gilead-sponsored studies were enrolled in this study. Participants did not receive any treatment during this study. Participants were examined to see the signs or symptoms of uterine cancer.

    Reporting group values
    		 Eleclazine Total
    Number of subjects
    		 77 77
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 62 62
        From 65-84 years
    		 15 15
    Gender categorical
    Units: Subjects
        Female
    		 77 77
        Male
    		 0 0
    Race
    Units: Subjects
        White
    		 66 66
        Black or African American
    		 7 7
        Not Collected
    		 3 3
        Asian
    		 1 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 50 50
        Hispanic or Latino
    		 24 24
        Not Collected
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Eleclazine
    Reporting group description
    		 Female participants who received eleclazine tablets at a dose of 1 mg, 3 mg, 6 mg, 10 mg or 60 mg in previous Gilead-sponsored studies were enrolled in this study. Participants did not receive any treatment during this study. Participants were examined to see the signs or symptoms of uterine cancer.

    Primary: Number of Female Participants Enrolled Who Signed the Informed Consent Form

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    End point title
    		 Number of Female Participants Enrolled Who Signed the Informed Consent Form [1]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 2.8 months
    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: No statistical comparison was planned or performed.
    End point values
    		 Eleclazine
    Number of subjects analysed
    77
    Units: participants
    69
    No statistical analyses for this end point

    Primary: Percentage of Female Participants with Signs or Symptoms Potentially Consistent with Uterine Cancer After Eleclazine Exposure

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    End point title
    		 Percentage of Female Participants with Signs or Symptoms Potentially Consistent with Uterine Cancer After Eleclazine Exposure [2]
    End point description
    The percentage of female participants with signs or symptoms potentially consistent with uterine cancer after eleclazine exposure included participants with uterine cancer reported on the medical history form or on the adverse event form or participants with symptoms reported on the Uterine Cancer symptom and risk factor form including intermenstrual or postmenopausal bleeding, pelvic pain and unexplained weight loss. Analysis Population Description: Enrolled population excluding participants enrolled with waiver: All female participants included in the enrolled population excluding participants with informed consent form (ICF) waiver obtained from institutional review board / ethics committee (IRB/EC).
    End point type
    Primary
    End point timeframe
    Up to 2.8 months
    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: No statistical comparison was planned or performed.
    End point values
    		 Eleclazine
    Number of subjects analysed
    69
    Units: percentage of participants
        number (confidence interval 95%)
    8.7 (3.3 to 18.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All-Cause Mortality: Up to 2.8 months Adverse Events: Up to 2.4 weeks
    Adverse event reporting additional description
    All-cause mortality and adverse events: Enrolled Population: All females who signed the informed consent form (ICF (or whose legally authorized representatives signed the ICF)) or enrolled with ICF waiver and met all eligibility criteria for the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Eleclazine
    Reporting group description
    		 Female participants who received eleclazine tablets at a dose of 1 mg, 3 mg, 6 mg, 10 mg or 60 mg in previous Gilead-sponsored studies were enrolled in this study. Participants did not receive any treatment during this study. Participants were examined to see the signs or symptoms of uterine cancer.

    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: The participants did not experience any non serious adverse events.
    Serious adverse events
    		 Eleclazine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 77 (10.39%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Procedural shock
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Cardiac failure chronic
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Thalamus haemorrhage
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hepatobiliary disorders
    Chronic hepatic failure
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    End stage renal disease
         subjects affected / exposed
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Eleclazine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 77 (0.00%)

    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.
    The data for deaths could not be collected for participants with waiver for participants who were deceased.
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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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