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    Clinical Trial Results:
    AN OPEN-LABEL STUDY OF SIPULEUCEL-T IN EUROPEAN MEN WITH METASTATIC, CASTRATE RESISTANT PROSTATE CANCER

    Summary
    EudraCT number
    2011-001192-39
    Trial protocol
    AT   GB   NL  
    Global end of trial date
    10 Jun 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Dec 2016
    First version publication date
    27 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P11-1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dendreon Pharmaceuticals, Inc
    Sponsor organisation address
    1301 2nd Avenue, Seattle, United States,
    Public contact
    Jennifer Lill, Dendreon Pharmaceuticals, Inc, +1 206-455-2174, jlill@dendreon.com
    Scientific contact
    Jennifer Lill, Dendreon Pharmaceuticals, Inc, +1 206-455-2174, jlill@dendreon.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
    10 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that sipuleucel-T can be successfully manufactured for subjects with mCRPC at a European manufacturing facility.
    Protection of trial subjects
    Utilization of an Independent Data Monitoring Committee that met at 3 month intervals and established procedures regarding chain of identity to ensure autologous product is delivered correctly.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Jun 2012
    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
    Netherlands: 15
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Austria: 17
    Country: Number of subjects enrolled
    France: 8
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    12
    From 65 to 84 years
    34
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Administration of informed consent, evaluation of inclusion criteria, clinical evaluations and assorted laboratory tests.

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

    Arms
    Arm title
    sipuleucel-T
    Arm description
    Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
    Arm type
    Experimental

    Investigational medicinal product name
    Sipuleucel-T
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 250 mL doses infused approximately 2 weeks apart.

    Number of subjects in period 1
    sipuleucel-T
    Started
    47
    Completed
    43
    Not completed
    4
         Started a medication restricted per the protocol
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    47 47
    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)
    12 12
        From 65-84 years
    34 34
        85 years and over
    1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.2 ± 7.8 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    47 47
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects registered were included in the analysis.

    Subject analysis sets values
    Full analysis
    Number of subjects
    47
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    12
        From 65-84 years
    34
        85 years and over
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.2 ± 7.8
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    47

    End points

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    End points reporting groups
    Reporting group title
    sipuleucel-T
    Reporting group description
    Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

    Subject analysis set title
    Full analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects registered were included in the analysis.

    Primary: Cumulative CD54 Upregulation

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    End point title
    Cumulative CD54 Upregulation [1]
    End point description
    End point type
    Primary
    End point timeframe
    Over 3 infusions of Sipuleucel-T
    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: Cumulative CD54 Upregulation parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3) and cumulative (summed across infusions). Descriptive statistics are sufficient for this single-arm study.
    End point values
    Full analysis
    Number of subjects analysed
    47
    Units: Ratio
        arithmetic mean (standard error)
    34.1 ± 1.24
    No statistical analyses for this end point

    Primary: CD54+ cell count

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    End point title
    CD54+ cell count [2]
    End point description
    End point type
    Primary
    End point timeframe
    Cumulative through infusion 3
    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: CD54+ cell count parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3) and cumulative (summed across infusions) Descriptive statistics are sufficient for this single-arm study.
    End point values
    Full analysis
    Number of subjects analysed
    Units: 10^9
        arithmetic mean (standard error)
    1.58 ± 0.1
    No statistical analyses for this end point

    Primary: Total nucleated cell count

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    End point title
    Total nucleated cell count [3]
    End point description
    End point type
    Primary
    End point timeframe
    Cumulative through infusion 3
    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: Total nucleated cell count parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3) and cumulative (summed across infusions) Descriptive statistics are sufficient for this single-arm study.
    End point values
    Full analysis
    Number of subjects analysed
    Units: 10^9
        arithmetic mean (standard error)
    12.54 ± 0.74
    No statistical analyses for this end point

    Primary: Product viability (percentage)

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    End point title
    Product viability (percentage) [4]
    End point description
    End point type
    Primary
    End point timeframe
    Infusion 3
    Notes
    [4] - 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: Product viability (percentage) parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3). Descriptive statistics are sufficient for this single-arm study.
    End point values
    Full analysis
    Number of subjects analysed
    Units: percentage
        arithmetic mean (full range (min-max))
    96.75 (90.4 to 99.53)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to last visit
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    -

    Serious adverse events
    All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 47 (6.38%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Gastroenteritis radiation
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pain
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 47 (85.11%)
    Injury, poisoning and procedural complications
    Citrate Toxicity
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 47 (10.64%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    14 / 47 (29.79%)
         occurrences all number
    14
    Chills
         subjects affected / exposed
    10 / 47 (21.28%)
         occurrences all number
    10
    Influenza like illness
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Pain
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 47 (10.64%)
         occurrences all number
    5
    Constipation
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    11 / 47 (23.40%)
         occurrences all number
    11
    Myalgia
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    4
    Arthralgia
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Bone pain
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jun 2012
    Quality of Life questionnaire assessments added. Clarification of sample size from 10 up to 45 subjects in the statistical analysis (justification for 45 subjects). Statistical clarification for the decision to stop enrollment.
    09 Jul 2013
    Added thromboembolic and CVE reporting criteria of all countries to align with IB, edition 18.
    02 Dec 2013
    Updated leukapheresis and sipuleucel-T risks sections, and infusion section to align with IB, edition 19.

    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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    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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