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    Clinical Trial Results:
    Phase II study of thalidomide in combination with temozolomide in metastatic malignant melanoma with brain metastases

    Summary
    EudraCT number
    2004-005164-25
    Trial protocol
    DK  
    Global end of trial date
    04 Dec 2007

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Jul 2021
    First version publication date
    21 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    04.09
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J. B. Winsløws vej 2, entrance 140, basement, Odense C, Denmark, 5000
    Public contact
    Ida Coordt Elle, Odense University Hospital, +45 29335922, ida.coordt.elle@rsyd.dk
    Scientific contact
    Lars Bastholt, Odense University Hospital, +45 24849408, lars.bastholt@rsyd.dk
    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
    01 Jul 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine tumor response rate including determination of stable disease
    Protection of trial subjects
    Treatment with steroids if necessary. Pre-medication to minimize adverse events.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jun 2004
    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
    Denmark: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    30
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    All patients included in the study had brain metastases in progression not amenable for surgery or stereotactic radiotherapy and due to limited symptoms whole brain radiotherapy was not indicated. WHO performance status (PS) ≤ 0.1.

    Pre-assignment
    Screening details
    Forty screened patients were eligible and evaluable for response, and 39 were evaluable for toxicity. 25 patients had asymptomatic and 15 symptomatic brain metastases.

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

    Arms
    Arm title
    Tem-Thal
    Arm description
    TMZ in a dose of 150 mg/m2 qd for seven days, followed by seven days off therapy and THA in 200 mg qd, both orally administered.
    Arm type
    Experimental

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg/m2 qd for seven days, followed by seven days off therapy.

    Investigational medicinal product name
    Thalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose of THA was 100 mg qd orally, taken in the evening to reduce drug-related daytime somnolence. The dose was escalated after one week to a maximum of 200 mg qd given continuously.

    Number of subjects in period 1
    Tem-Thal
    Started
    40
    Completed
    40

    Baseline characteristics

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

    Reporting group values
    Trial Total
    Number of subjects
    40 40
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    55 (29 to 76) -
    Gender categorical
    Patients in the trial.
    Units: Subjects
        Female
    21 21
        Male
    19 19
    Performance status
    Units: Subjects
        PS0
    16 16
        PS1
    24 24
    Subject analysis sets

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Forty screened patients were eligible and evaluable for response, and 39 were evaluable for toxicity. 25 patients had asymptomatic and 15 symptomatic brain metastases.

    Subject analysis sets values
    Patients
    Number of subjects
    40
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    55 (29 to 76)
    Gender categorical
    Patients in the trial.
    Units: Subjects
        Female
    21
        Male
    19
    Performance status
    Units: Subjects
        PS0
    16
        PS1
    24

    End points

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    End points reporting groups
    Reporting group title
    Tem-Thal
    Reporting group description
    TMZ in a dose of 150 mg/m2 qd for seven days, followed by seven days off therapy and THA in 200 mg qd, both orally administered.

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Forty screened patients were eligible and evaluable for response, and 39 were evaluable for toxicity. 25 patients had asymptomatic and 15 symptomatic brain metastases.

    Primary: Response rate (CR+PR+SD)

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    End point title
    Response rate (CR+PR+SD) [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 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: Please see attached publication for full statistical analysis.
    End point values
    Tem-Thal Patients
    Number of subjects analysed
    40
    40
    Units: percent
    number (not applicable)
        Response rate
    17.5
    17.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days post-last treatment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Patients
    Reporting group description
    -

    Serious adverse events
    Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 40 (47.50%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Lymphopenia
    Additional description: Grade 3+4
         subjects affected / exposed
    19 / 40 (47.50%)
         occurrences causally related to treatment / all
    19 / 19
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 40 (92.50%)
    Vascular disorders
    Embolism
    Additional description: Thrombo-embolism
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Lymphopenia
    Additional description: Grade 1+2
         subjects affected / exposed
    13 / 40 (32.50%)
         occurrences all number
    13
    Nervous system disorders
    Neurotoxicity
         subjects affected / exposed
    14 / 40 (35.00%)
         occurrences all number
    14
    General disorders and administration site conditions
    Dry mouth
         subjects affected / exposed
    32 / 40 (80.00%)
         occurrences all number
    32
    Fatigue
         subjects affected / exposed
    37 / 40 (92.50%)
         occurrences all number
    37
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    20 / 40 (50.00%)
         occurrences all number
    20
    Constipation
         subjects affected / exposed
    31 / 40 (77.50%)
         occurrences all number
    31
    Diarrhoea
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    23 / 40 (57.50%)
         occurrences all number
    23
    Vomiting
         subjects affected / exposed
    24 / 40 (60.00%)
         occurrences all number
    24
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    22 / 40 (55.00%)
         occurrences all number
    22

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/22275974
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