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    Clinical Trial Results:
    A Phase II, Open-Label Study To Assess The Efficacy and Tolerability of ZD6474 (ZACTIMA) 100mg Monotherapy In Subjects with Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer

    Summary
    EudraCT number
    2006-001354-28
    Trial protocol
    NL   ES   IT  
    Global end of trial date
    30 May 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    21 May 2016
    First version publication date
    21 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D4200C00068
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Lisa McCormack, AstraZeneca Pharmaceuticals. LP, +44 01625 5151063, lisa.mccormack@astrazeneca.com
    Scientific contact
    Gabriella Mariani, AstraZeneca Pharmaceuticals. LP, +44 07818523899, gabriella.mariani@astrazeneca.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
    11 Jul 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to determine the objective response rate in patients treated with vandetanib 100 mg monotherapy.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/GCP, applicable regulatory requirements and the AstraZeneca policy on Bioethics.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Aug 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    2 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    22
    EEA total number of subjects
    14
    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)
    19
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    22
    Number of subjects completed
    19

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Incorrect enrollment: 2
    Reason: Number of subjects
    Consent withdrawn by subject: 1
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Arm title
    Vandetanib 100mg
    Arm description
    Vandetanib 100mg per day
    Arm type
    Experimental

    Investigational medicinal product name
    ZD6474
    Investigational medicinal product code
    F013025
    Other name
    ZACTIMA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 100mg tablet to be taken whole, orally per day.

    Number of subjects in period 1 [1]
    Vandetanib 100mg
    Started
    19
    Completed
    19
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 22 patients were enrolled worldwide but 3 patients did not pass screening – 2 had the incorrect enrolment and 1 withdrew their consent, thus only 19 patients entered the baseline period which is less than the number enrolled.
    Period 2
    Period 2 title
    100mg Vandetanib
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    Vandetanib 100mg
    Arm description
    Vandetanib 100mg per day
    Arm type
    Experimental

    Investigational medicinal product name
    ZD6474
    Investigational medicinal product code
    F013025
    Other name
    ZACTIMA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 100mg tablet to be taken whole, orally per day.

    Number of subjects in period 2
    Vandetanib 100mg
    Started
    19
    Completed
    11
    Not completed
    8
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    3
         Lack of efficacy
    4
    Period 3
    Period 3 title
    Post-Progression Vandetanib 300mg
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Arm title
    Post Progression Treatment
    Arm description
    Post progression Vandetanib 300mg per day
    Arm type
    Experimental

    Investigational medicinal product name
    ZD6474
    Investigational medicinal product code
    F013383
    Other name
    ZACTIMA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 300mg tablet to be taken whole, orally per day.

    Number of subjects in period 3 [2]
    Post Progression Treatment
    Started
    4
    Completed
    3
    Not completed
    1
         Lack of efficacy
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: "Post-progression Van 300mg” part of the study is optional and only 4 of the 19 patients that started the 100mg part, opted to continue on the 300mg, thus the number is less than the 100 mg patient numbers.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vandetanib 100mg
    Reporting group description
    Vandetanib 100mg per day

    Reporting group values
    Vandetanib 100mg Total
    Number of subjects
    19 19
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    17 17
        From 65-74 years
    1 1
        75 years and over
    1 1
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    44.7 (22 to 79) -
    Gender Categorical
    Units: Subjects
        Female
    6 6
        Male
    13 13
    Race
    Units: Subjects
        Caucasian
    18 18
        Other
    1 1
    Ethnic Group
    Units: Subjects
        Not applicable
    17 17
        Native Hawaiian/Pacific islander
    1 1
        Other
    1 1
    Disease Stage
    Units: Subjects
        IVA
    1 1
        IVC
    18 18
    Locally advanced disease sites
    Units: Subjects
        Lymph nodes
    7 7
        Neck
    1 1
        Other sites
    1 1
        None
    10 10
    Previous therapies for MTC
    Units: Subjects
        Anticancer therapy
    6 6
        Radiotherapy
    4 4
        Chemotherapy
    2 2
        None
    7 7
    Family history of MTC
    Units: Subjects
        Yes
    14 14
        No
    3 3
        Unknown
    2 2
    Associated endocrinopathies
    Units: Subjects
        MEN 2a
    17 17
        FMTC
    1 1
        MEN 2b
    1 1
    RET mutation status
    Units: Subjects
        Positive
    17 17
        Negative
    0 0
        Unknown
    2 2
    WHO performance status at entry
    Units: Subjects
        0 (Normal activity)
    16 16
        1 (Restricted activity)
    1 1
        2 (In bed ≤50% of the time)
    2 2
        3 (In bed >50% of the time)
    0 0
        4 (100% bedridden)
    0 0
    Time since diagnosis
    Units: years
        arithmetic mean (full range (min-max))
    13 (5 to 33) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set consisted of all patients who received at least 1 dose of vandetanib.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set comprised all patients who received at least 1 dose of vandetanib.

    Subject analysis set title
    PK Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The PK analysis population consisted of all patients who received at least 1 dose of vandetanib.

    Subject analysis sets values
    Full Analysis Set Safety Analysis Set PK Analysis Set
    Number of subjects
    19
    19
    19
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    17
    17
    17
        From 65-74 years
    1
    1
    1
        75 years and over
    1
    1
    1
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    44.7 (22 to 79)
    44.7 (22 to 79)
    44.7 (22 to 79)
    Gender Categorical
    Units: Subjects
        Female
    6
    6
    6
        Male
    13
    13
    13
    Race
    Units: Subjects
        Caucasian
    18
    18
    18
        Other
    1
    1
    1
    Ethnic Group
    Units: Subjects
        Not applicable
    17
    17
    17
        Native Hawaiian/Pacific islander
    1
    1
    1
        Other
    1
    1
    1
    Disease Stage
    Units: Subjects
        IVA
    1
    1
    1
        IVC
    18
    18
    18
    Locally advanced disease sites
    Units: Subjects
        Lymph nodes
    7
    7
    7
        Neck
    1
    1
    1
        Other sites
    1
    1
    1
        None
    10
    10
    10
    Previous therapies for MTC
    Units: Subjects
        Anticancer therapy
    6
    6
    6
        Radiotherapy
    4
    4
    4
        Chemotherapy
    2
    2
    2
        None
    7
    7
    7
    Family history of MTC
    Units: Subjects
        Yes
    14
    14
    14
        No
    3
    3
    3
        Unknown
    2
    2
    2
    Associated endocrinopathies
    Units: Subjects
        MEN 2a
    17
    17
    17
        FMTC
    1
    1
    1
        MEN 2b
    1
    1
    1
    RET mutation status
    Units: Subjects
        Positive
    17
    17
    17
        Negative
    0
    0
    0
        Unknown
    2
    2
    2
    WHO performance status at entry
    Units: Subjects
        0 (Normal activity)
    16
    16
    16
        1 (Restricted activity)
    1
    1
    1
        2 (In bed ≤50% of the time)
    2
    2
    2
        3 (In bed >50% of the time)
    0
    0
    0
        4 (100% bedridden)
    0
    0
    0
    Time since diagnosis
    Units: years
        arithmetic mean (full range (min-max))
    13 (5 to 33)
    13 (5 to 33)
    13 (5 to 33)

    End points

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    End points reporting groups
    Reporting group title
    Vandetanib 100mg
    Reporting group description
    Vandetanib 100mg per day
    Reporting group title
    Vandetanib 100mg
    Reporting group description
    Vandetanib 100mg per day
    Reporting group title
    Post Progression Treatment
    Reporting group description
    Post progression Vandetanib 300mg per day

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set consisted of all patients who received at least 1 dose of vandetanib.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set comprised all patients who received at least 1 dose of vandetanib.

    Subject analysis set title
    PK Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The PK analysis population consisted of all patients who received at least 1 dose of vandetanib.

    Primary: Objective Response Rate

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    End point title
    Objective Response Rate [1]
    End point description
    Responders were those patients with a best objective response of CR or PR. A best response of CR meant that the patient satisfied the criteria for CR on 1 visit,and that the CR status was confirmed by repeat imaging at not less than 4 weeks following the date of identified CR. A best response of PR meant that the patient satisfied the criteria for PR on 1 visit, confirmed by repeat imaging at not less than 4 weeks following the date of PR.
    End point type
    Primary
    End point timeframe
    Best response during 100mg Vandetanib period
    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: As this is a small single arm study there are no formal statistical analyses.
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    19
    Units: Subjects
        Response - CR
    0
        Response - PR
    3
        Response - Total
    3
        Non response - SD >= 8wks
    12
        Non response - PD
    3
        Non response - NE
    1
        Non response - Total
    16
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    Progression Free Survival
    End point description
    PFS is calculated from the date of first dose until the date of objective progression or death (by any cause in the absence of documented disease progression). Subjects who have not progressed or died at the time of statistical analysis will be censored at the time of their latest objective tumor assessment. This includes subjects who are lost to follow-up or those who have withdrawn consent.
    End point type
    Secondary
    End point timeframe
    PFS during 100mg Vandetanib period
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    19
    Units: Subjects
        Progression - RECIST
    4
        Progression - Death
    1
        Progression - Total
    5
        No Progression - Alive
    14
        No Progression - Death
    0
        No Progression - Lost to FUP
    0
        No Progression - Total
    14
    No statistical analyses for this end point

    Secondary: Disease Control Rate

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    End point title
    Disease Control Rate
    End point description
    DCR will be based upon data from assessments performed at baseline, during treatment, and at follow-up. DCR will be defined as the percentage of subjects who have a best response of CR, or PR or SD ≥12 weeks.
    End point type
    Secondary
    End point timeframe
    DCR during 100mg Vandetanib period
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    19
    Units: Subjects
        Disease Control
    13
        No Disease Control
    6
    No statistical analyses for this end point

    Secondary: Duration of Objective Response

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    End point title
    Duration of Objective Response
    End point description
    DOR will be calculated for those subjects who have a best response of CR or PR.DOR will be defined in two ways:1. From date of first documentation of the response until the date of disease progression or death from any cause.2. From date of first dose until the date of disease progression or death from any cause.
    End point type
    Secondary
    End point timeframe
    DOR during the 100mg Vandetanib period
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    3
    Units: Days
    median (confidence interval 95%)
        Duration of response from onset of response
    168 (158 to 245)
        Duration of response from first dose
    252 (246 to 400)
        Time to response from first dose
    89 (85 to 156)
    No statistical analyses for this end point

    Secondary: Duration of Disease Control

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    End point title
    Duration of Disease Control
    End point description
    Duration of disease control will be calculated for those subjects who have a best response of CR, PR or SD ≥12 weeks only.Duration of disease control will be defined from date of first dose until the date of disease progression or death from any cause. Any subject who has not progressed or died by the date of data cut-off, or who has been lost to follow up, will be right-censored in the analysis at the date of their last disease assessment.
    End point type
    Secondary
    End point timeframe
    Duration of disease control during the 100mg Vandetanib period
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    13
    Units: Days
    median (confidence interval 95%)
        Duration of disease control
    256 (246 to 343)
    No statistical analyses for this end point

    Secondary: Symptomatic Diarrhoea Response

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    End point title
    Symptomatic Diarrhoea Response
    End point description
    Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level.
    End point type
    Secondary
    End point timeframe
    Response during the 100mg Vandetanib period
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    19
    Units: Subjects
        Symptomatic Response
    0
        No Symptomatic Response
    19
    No statistical analyses for this end point

    Secondary: Best Objective Response and CTN Biochemical Response

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    End point title
    Best Objective Response and CTN Biochemical Response
    End point description
    BOR based on CTN biochemical response
    End point type
    Secondary
    End point timeframe
    CTN response during the 100mg Vandetanib period
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    19
    Units: Subjects
        Response - CR
    0
        Response - PR
    3
        Response - Total
    3
        Non-response - SD
    13
        Non-response- PD
    2
        Non-response - NE
    1
        Non-response - Total
    16
    No statistical analyses for this end point

    Secondary: Best Objective Response and CEA Biochemical Response

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    End point title
    Best Objective Response and CEA Biochemical Response
    End point description
    BOR based on CEA biochemical response
    End point type
    Secondary
    End point timeframe
    Response during the 100mg Vandetanib period
    End point values
    Vandetanib 100mg
    Number of subjects analysed
    19
    Units: Subjects
        Response - CR
    0
        Response - PR
    1
        Response - Total
    1
        Non-response - SD
    11
        Non-response PD
    2
        Non-respons - NE
    5
        Non-response - Total
    18
    No statistical analyses for this end point

    Other pre-specified: Objective Progression

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    End point title
    Objective Progression
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Including 300mg Vandetanib period
    End point values
    Post Progression Treatment
    Number of subjects analysed
    4
    Units: Subjects
        Progression - RECIST
    1
        Progression - Death
    0
        Progression - Total
    1
        No Progression - Alive
    3
        No Progression - Death
    0
        No Progression - Lost to FUP
    0
        No Progression - Total
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to end of 60-day follow-up period.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Post Progression Treatment
    Reporting group description
    Post progression 300mg Vandetanib

    Reporting group title
    Vandetanib 100mg
    Reporting group description
    Vandetanib 100mg per day

    Serious adverse events
    Post Progression Treatment Vandetanib 100mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 19 (21.05%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Phaechromocytoma
    alternative dictionary used: MedDRA 10.1
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia Aspiration
    alternative dictionary used: MedDRA 10.1
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endocrine disorders
    Diabetes Disorders
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Post Progression Treatment Vandetanib 100mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    17 / 19 (89.47%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Flushing
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    8 / 19 (42.11%)
         occurrences all number
    0
    9
    Asthenia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Influenza Like Illness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Mucous Membrane Disorde
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Thirst
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Erectile Dysfunction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Menorrhagia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Coughing
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Dyspnea Exertional
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pharyngolaryngeal Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Haemoptysi
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Investigations
    Weight Decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Weight Increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Dysarthria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Deafness Unilateral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Diplopia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Visual Disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhea NOS
         subjects affected / exposed
    1 / 4 (25.00%)
    9 / 19 (47.37%)
         occurrences all number
    1
    11
    Constipation
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 19 (21.05%)
         occurrences all number
    0
    4
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Abdominal Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Flatulenc
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Dry Mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Oral Discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 19 (26.32%)
         occurrences all number
    0
    5
    Photosensitivity reaction (NOS)
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Dermatitis Acneiform
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    4
    Dry Skin
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Acne NOS
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pruritis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Rash Erythematou
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Rash Maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Skin Exfoliatio
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Renal Failure
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Mobility Decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Muscle Spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Muscular Weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Myalg
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Neck Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Furuncle
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Tinea Pedis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Upper resp tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 19 (15.79%)
         occurrences all number
    1
    3
    Hypocalcemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2006
    Increase number of sites; clarification on post-progression 300mg treatment phase; further explanation of RECIST assessment schedule for subjects discontinuning treatment; increase ECG monitoring for subjects in 300mg treatment period; clarify and make consistent schedule of assessments
    09 Oct 2006
    Clarification of schedule of assessments and procedures. Addition of patients with CTCAE Grade 4 HTN having treatment withheld; clarification of administration of treatment; blood sampling schedule and change in personnel
    18 Nov 2009
    Include procedures for management of subjects still receiving treatment following final planned analyses.
    04 Nov 2011
    Update list of medications with possible risk of TdP; approval of ZD6474 by FDA, additional regulatory approvals pending

    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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