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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled Phase II-III multi-centre study to evaluate the effect of adjuvant pazopanib (GW786034) versus placebo on post-surgical disease-free survival in patients with stage I non small cell lung cancer and tumor size equal or inferior to 7 cm.

    Summary
    EudraCT number
    		 2008-004897-41
    Trial protocol
    		 FR  
    Global end of trial date
    01 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2023
    First version publication date
    10 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFCT-0703
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00775307
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IFCT
    Sponsor organisation address
    10 rue de la Grange Batelière , Paris, France, 75009
    Public contact
    Contact, IFCT, +33 156811045, contact@ifct.fr
    Scientific contact
    Contact, IFCT, +33 156811045, contact@ifct.fr
    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 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate ‘feasibility of regimen’ by measuring compliance in patients with once-daily (QD) pazopanib, or placebo, dosed according to protocol, based on the proportion (%) of patients that receive pazopanib, or placebo, for at least 12 weeks within 24 weeks of randomization.
    Protection of trial subjects
    Algorithms for management of adverse events were provided in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2009
    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
    France: 142
    Worldwide total number of subjects
    142
    EEA total number of subjects
    142
    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)
    114
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between March 2009 and August 2012, 143 patients were randomly assigned, 72 to pazopanib and 71 to placebo, in 29 centers. One patient (pazopanib arm) was ineligible being randomized without consent (and did not receive any treatment) and was excluded from all analyses.

    Pre-assignment
    Screening details
    		 Patients (18 to 70 years) with completely resected stage I NSCLC (7th TNM edition), an ECOG performance status of 0 or 1, and adequate hematologic, hepatic, renal, and blood coagulation function were eligible.

    Pre-assignment period milestones
    Number of subjects started
    		 142
    Number of subjects completed
    		 142

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    This double-blind, multicenter, phase II/III study assigned by central randomization (1:1, block method)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pazopanib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    GW786034
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib was administered at 800 or 400 mg once a day. After 64 patients were included (interim analysis), the independent data monitoring committee (IDMC) recommended reducing the pazopanib dose to 400 mg/day given insufficient compliance.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered at 800 or 400 mg once a day. After 64 patients were included (interim analysis), the independent data monitoring committee (IDMC) recommended reducing the dose to 400 mg/day given insufficient compliance.

    Number of subjects in period 1
    		Pazopanib Placebo
    Started
    71
    71
    Completed
    69
    69
    Not completed
    2
    2
         Physician decision
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Pazopanib Placebo Total
    Number of subjects
    		 71 71 142
    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))
    		 57 (33 to 70) 61 (44 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 30 26 56
        Male
    		 41 45 86
    ECOG performance status
    Units: Subjects
        PS 0
    		 47 58 105
        PS 1
    		 24 13 37
    Ethnicity
    Units: Subjects
        Caucasian
    		 69 69 138
        Other
    		 2 2 4
    Smoking status
    Units: Subjects
        Never
    		 6 6 12
        Current
    		 13 12 25
        Former
    		 52 52 104
        Missing
    		 0 1 1
    Stage
    Units: Subjects
        IA
    		 54 59 113
        IB
    		 16 12 28
        Missing
    		 1 0 1
    Histology
    Units: Subjects
        Adenocarcinoma
    		 51 56 107
        Squamous cell carcinoma
    		 12 11 23
        Other
    		 8 4 12

    End points

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    End points reporting groups
    Reporting group title
    Pazopanib
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Compliance rate by planned dose and treatment arm

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    End point title
    		 Compliance rate by planned dose and treatment arm [1]
    End point description
    To evaluate ‘feasibility of regimen’ by measuring compliance in patients with once-daily (QD) pazopanib, or placebo, dosed according to protocol, based on the proportion (%) of patients that receive pazopanib, or placebo, for at least 12 weeks within 24 weeks of randomization.
    End point type
    Primary
    End point timeframe
    Within 24 weeks of randomization.
    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: Not available
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: % of patients
    number (confidence interval 95%)
        800 mg/day
    38 (23 to 55)
    88 (73 to 96)
        400 mg/day
    69 (50 to 84)
    93 (77 to 99)
    No statistical analyses for this end point

    Secondary: Duration of treatment

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    End point title
    		 Duration of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Within 24 weeks of randomization
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: weeks
    median (full range (min-max))
        800 mg/day
    7.2 (0.3 to 26.0)
    24.1 (0.3 to 26.4)
        400 mg/day
    22.6 (0.7 to 26.6)
    24.3 (0.3 to 26.3)
    No statistical analyses for this end point

    Secondary: Dose modification

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    End point title
    		 Dose modification
    End point description
    End point type
    Secondary
    End point timeframe
    Within 24 weeks of randomization
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: Number of patients
        800 mg/day
    16
    2
        400 mg/day
    12
    2
    No statistical analyses for this end point

    Secondary: Number of dose modification

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    End point title
    		 Number of dose modification
    End point description
    End point type
    Secondary
    End point timeframe
    Within 24 weeks from randomization
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: Number of patients
        800 mg/day : 1 dose reduction
    13
    12
        800 mg/day : 2 dose reductions
    3
    2
        400 mg/day : 1 dose reduction
    2
    0
        400 mg/day :2 dose reductions
    0
    0
    No statistical analyses for this end point

    Secondary: Quality of life

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    End point title
    		 Quality of life
    End point description
    End point type
    Secondary
    End point timeframe
    Within 24 weeks from randomization
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: Pourcentage
    arithmetic mean (standard error)
        Global Health Status : baseline
    64.9 ± 17.4
    67.8 ± 20.5
        Global Health Status : W12
    63.2 ± 20.3
    72.7 ± 18.1
        Global Health Status : W24
    64.1 ± 20.1
    68.6 ± 23.1
        Physical functioning : baseline
    84.4 ± 12.8
    83.2 ± 15.0
        Physical functioning : W12
    81.0 ± 15.6
    84.4 ± 14.5
        Physical functioning : W24
    86.4 ± 13.4
    86.1 ± 12.0
        Fatigue : baseline
    31.3 ± 22.8
    32.4 ± 23.8
        Fatigue : W12
    32.3 ± 23.2
    27.1 ± 25.6
        Fatigue : W24
    31.6 ± 25.9
    23.8 ± 21.9
        Nausea and vomiting : baseline
    3.5 ± 9.6
    5.4 ± 11.8
        Nausea and vomiting : W12
    7.0 ± 16.7
    8.2 ± 15.3
        Nausea and vomiting : W24
    9.6 ± 17.1
    4.3 ± 12.3
        Dyspnoea : baseline
    24.2 ± 18.5
    25.5 ± 20.7
        Dyspnoea : W12
    24.2 ± 22.9
    23.6 ± 21.2
        Dyspnoea : W24
    26.4 ± 22.7
    25.4 ± 20.8
        Pain in chest : baseline
    18.8 ± 27.4
    20.6 ± 23.8
        Pain in chest : W12
    17.1 ± 24.9
    20.8 ± 24.5
        Pain in chest : W24
    14.7 ± 21.7
    14.6 ± 19.3
    No statistical analyses for this end point

    Post-hoc: Quality of blinding - Treatment guess by patient

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    End point title
    		 Quality of blinding - Treatment guess by patient
    End point description
    End point type
    Post-hoc
    End point timeframe
    Up to 47 months
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    69
    69
    Units: Number of patients
        Placebo
    3
    32
        Pazopanib
    61
    29
        Missing
    5
    8
    No statistical analyses for this end point

    Post-hoc: Quality of blinding - Treatment guess by investigator

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    End point title
    		 Quality of blinding - Treatment guess by investigator
    End point description
    End point type
    Post-hoc
    End point timeframe
    Up to 47 months
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    69
    69
    Units: Number of patients
        Placebo
    5
    48
        Pazopanib
    62
    15
        Missing
    2
    6
    No statistical analyses for this end point

    Post-hoc: Quality of blinding - Concordance between patients’ and clinicians’ guess of treatment

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    End point title
    		 Quality of blinding - Concordance between patients’ and clinicians’ guess of treatment
    End point description
    End point type
    Post-hoc
    End point timeframe
    Up to 47 weeks
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    64
    56
    Units: Number of patients
        Yes
    5
    17
        No
    59
    39
    No statistical analyses for this end point

    Post-hoc: 5-year overall survival

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    End point title
    		 5-year overall survival
    End point description
    End point type
    Post-hoc
    End point timeframe
    Up to 47 months
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: % of patients
        number (confidence interval 95%)
    83 (72 to 94)
    94 (88 to 100)
    No statistical analyses for this end point

    Post-hoc: Three-year Recurrence-Free Survival

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    End point title
    		 Three-year Recurrence-Free Survival
    End point description
    End point type
    Post-hoc
    End point timeframe
    Up to 47 months
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: % of patients
        number (confidence interval 95%)
    76 (65 to 86)
    83 (74 to 92)
    No statistical analyses for this end point

    Post-hoc: Second primary cancers

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    End point title
    		 Second primary cancers
    End point description
    End point type
    Post-hoc
    End point timeframe
    Up to 47 patients
    End point values
    		 Pazopanib Placebo
    Number of subjects analysed
    71
    71
    Units: Number of patients
        800 mg/day
    8
    3
        400 mg/day
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected for a patient from the date of signature of inform consent form, during treatment period and until 30 days after the last dose of study treatment. Deaths were collected until data analysis.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Safety population - Pazopanib 800 mg
    Reporting group description
    		 -

    Reporting group title
    Safety population - Placebo 800 mg
    Reporting group description
    		 -

    Reporting group title
    Safety population - Pazopanib 400 mg
    Reporting group description
    		 -

    Reporting group title
    Safety population - Placebo 400 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population - Pazopanib 800 mg Safety population - Placebo 800 mg Safety population - Pazopanib 400 mg Safety population - Placebo 400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 41 (4.88%)
    4 / 32 (12.50%)
    3 / 30 (10.00%)
         number of deaths (all causes)
    6
    1
    1
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Frature
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reduced general condition
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Pregnancy of partner
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bloody diarrhea
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population - Pazopanib 800 mg Safety population - Placebo 800 mg Safety population - Pazopanib 400 mg Safety population - Placebo 400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 39 (97.44%)
    39 / 41 (95.12%)
    31 / 32 (96.88%)
    29 / 30 (96.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    21 / 39 (53.85%)
    11 / 41 (26.83%)
    16 / 32 (50.00%)
    2 / 30 (6.67%)
         occurrences all number
    21
    11
    16
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    23 / 39 (58.97%)
    19 / 41 (46.34%)
    26 / 32 (81.25%)
    15 / 30 (50.00%)
         occurrences all number
    23
    19
    26
    15
    Fever
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 41 (9.76%)
    4 / 32 (12.50%)
    0 / 30 (0.00%)
         occurrences all number
    1
    4
    4
    0
    Pain
         subjects affected / exposed
    22 / 39 (56.41%)
    19 / 41 (46.34%)
    24 / 32 (75.00%)
    22 / 30 (73.33%)
         occurrences all number
    22
    19
    24
    22
    Respiratory, thoracic and mediastinal disorders
    Haemorrhage nose
         subjects affected / exposed
    5 / 39 (12.82%)
    1 / 41 (2.44%)
    2 / 32 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    5
    1
    2
    2
    Cough
         subjects affected / exposed
    13 / 39 (33.33%)
    16 / 41 (39.02%)
    10 / 32 (31.25%)
    14 / 30 (46.67%)
         occurrences all number
    13
    16
    10
    14
    Dyspnea
         subjects affected / exposed
    12 / 39 (30.77%)
    19 / 41 (46.34%)
    15 / 32 (46.88%)
    10 / 30 (33.33%)
         occurrences all number
    12
    19
    15
    10
    Voice change
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 41 (4.88%)
    2 / 32 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    3
    2
    2
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 39 (5.13%)
    9 / 41 (21.95%)
    5 / 32 (15.63%)
    5 / 30 (16.67%)
         occurrences all number
    2
    9
    5
    5
    Mood altered
         subjects affected / exposed
    5 / 39 (12.82%)
    4 / 41 (9.76%)
    6 / 32 (18.75%)
    5 / 30 (16.67%)
         occurrences all number
    5
    4
    6
    5
    Irritability
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    3 / 30 (10.00%)
         occurrences all number
    0
    0
    1
    3
    Investigations
    Weight loss
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Alanine aminotransferase
         subjects affected / exposed
    17 / 39 (43.59%)
    12 / 41 (29.27%)
    17 / 32 (53.13%)
    4 / 30 (13.33%)
         occurrences all number
    17
    12
    17
    4
    Aspartate aminotransferase
         subjects affected / exposed
    18 / 39 (46.15%)
    14 / 41 (34.15%)
    10 / 32 (31.25%)
    5 / 30 (16.67%)
         occurrences all number
    18
    14
    10
    5
    Alkaline phosphatase
         subjects affected / exposed
    6 / 39 (15.38%)
    7 / 41 (17.07%)
    5 / 32 (15.63%)
    3 / 30 (10.00%)
         occurrences all number
    6
    7
    5
    3
    Bicarbonate serum-low
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 41 (7.32%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Bilirubin
         subjects affected / exposed
    9 / 39 (23.08%)
    7 / 41 (17.07%)
    6 / 32 (18.75%)
    2 / 30 (6.67%)
         occurrences all number
    9
    7
    6
    2
    Cholesterol
         subjects affected / exposed
    9 / 39 (23.08%)
    15 / 41 (36.59%)
    13 / 32 (40.63%)
    15 / 30 (50.00%)
         occurrences all number
    9
    15
    13
    15
    Creatinine
         subjects affected / exposed
    0 / 39 (0.00%)
    4 / 41 (9.76%)
    2 / 32 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    4
    2
    1
    Gamma-glutamyltransferase
         subjects affected / exposed
    15 / 39 (38.46%)
    16 / 41 (39.02%)
    12 / 32 (37.50%)
    11 / 30 (36.67%)
         occurrences all number
    15
    16
    12
    11
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 39 (2.56%)
    6 / 41 (14.63%)
    1 / 32 (3.13%)
    4 / 30 (13.33%)
         occurrences all number
    1
    6
    1
    4
    Headache
         subjects affected / exposed
    11 / 39 (28.21%)
    6 / 41 (14.63%)
    11 / 32 (34.38%)
    5 / 30 (16.67%)
         occurrences all number
    11
    6
    11
    5
    Memory impairment
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 41 (4.88%)
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    0
    2
    Neuropathy-sensory
         subjects affected / exposed
    0 / 39 (0.00%)
    4 / 41 (9.76%)
    1 / 32 (3.13%)
    1 / 30 (3.33%)
         occurrences all number
    0
    4
    1
    1
    Blood and lymphatic system disorders
    Haemoglobin
         subjects affected / exposed
    7 / 39 (17.95%)
    9 / 41 (21.95%)
    5 / 32 (15.63%)
    5 / 30 (16.67%)
         occurrences all number
    7
    9
    5
    5
    Leukocyte
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 41 (0.00%)
    3 / 32 (9.38%)
    1 / 30 (3.33%)
         occurrences all number
    3
    0
    3
    1
    Lymphopenia
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 41 (7.32%)
    2 / 32 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    3
    3
    2
    2
    Neutrophil
         subjects affected / exposed
    5 / 39 (12.82%)
    4 / 41 (9.76%)
    9 / 32 (28.13%)
    2 / 30 (6.67%)
         occurrences all number
    5
    4
    9
    2
    Platelet
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 41 (2.44%)
    7 / 32 (21.88%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    7
    1
    Eye disorders
    Blurred vision
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 41 (0.00%)
    4 / 32 (12.50%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    4
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    15 / 39 (38.46%)
    5 / 41 (12.20%)
    10 / 32 (31.25%)
    2 / 30 (6.67%)
         occurrences all number
    15
    5
    10
    2
    Anorexia
         subjects affected / exposed
    16 / 39 (41.03%)
    5 / 41 (12.20%)
    8 / 32 (25.00%)
    2 / 30 (6.67%)
         occurrences all number
    16
    5
    8
    2
    Constipation
         subjects affected / exposed
    4 / 39 (10.26%)
    5 / 41 (12.20%)
    2 / 32 (6.25%)
    3 / 30 (10.00%)
         occurrences all number
    4
    5
    2
    3
    Diarrhoea
         subjects affected / exposed
    24 / 39 (61.54%)
    11 / 41 (26.83%)
    21 / 32 (65.63%)
    8 / 30 (26.67%)
         occurrences all number
    24
    1
    21
    8
    Dysguesia
         subjects affected / exposed
    9 / 39 (23.08%)
    2 / 41 (4.88%)
    3 / 32 (9.38%)
    0 / 30 (0.00%)
         occurrences all number
    9
    2
    3
    0
    Flatulence
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 41 (2.44%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    0
    2
    Mucositis stomatitis
         subjects affected / exposed
    5 / 39 (12.82%)
    2 / 41 (4.88%)
    3 / 32 (9.38%)
    0 / 30 (0.00%)
         occurrences all number
    5
    2
    3
    0
    Nausea
         subjects affected / exposed
    18 / 39 (46.15%)
    5 / 41 (12.20%)
    14 / 32 (43.75%)
    3 / 30 (10.00%)
         occurrences all number
    18
    5
    14
    3
    Vomiting
         subjects affected / exposed
    10 / 39 (25.64%)
    7 / 41 (17.07%)
    9 / 32 (28.13%)
    5 / 30 (16.67%)
         occurrences all number
    10
    7
    9
    5
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    1
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 39 (12.82%)
    1 / 41 (2.44%)
    9 / 32 (28.13%)
    3 / 30 (10.00%)
         occurrences all number
    5
    1
    9
    3
    Dry skin
         subjects affected / exposed
    5 / 39 (12.82%)
    1 / 41 (2.44%)
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    5
    1
    1
    2
    Erythema multiforme
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 41 (2.44%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Hand foot skin reaction
         subjects affected / exposed
    4 / 39 (10.26%)
    0 / 41 (0.00%)
    2 / 32 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    4
    0
    2
    1
    Hyperpigmentation
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 41 (4.88%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hypopigmentation
         subjects affected / exposed
    13 / 39 (33.33%)
    2 / 41 (4.88%)
    19 / 32 (59.38%)
    4 / 30 (13.33%)
         occurrences all number
    13
    2
    19
    4
    Pruritus
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 41 (7.32%)
    2 / 32 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    2
    3
    2
    2
    Rash
         subjects affected / exposed
    8 / 39 (20.51%)
    6 / 41 (14.63%)
    5 / 32 (15.63%)
    3 / 30 (10.00%)
         occurrences all number
    8
    6
    5
    3
    Ulceration
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 41 (7.32%)
    2 / 32 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    2
    3
    2
    1
    Dermatitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)
    2 / 32 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    2
    2
    Renal and urinary disorders
    Haemoglobinuria
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 41 (2.44%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 41 (4.88%)
    2 / 32 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    2
    2
    Proteinuria
         subjects affected / exposed
    19 / 39 (48.72%)
    16 / 41 (39.02%)
    10 / 32 (31.25%)
    3 / 30 (10.00%)
         occurrences all number
    19
    16
    10
    3
    Endocrine disorders
    Hot flashes
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 41 (7.32%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 41 (4.88%)
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    0
    2
    Hypothyroidism
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 41 (4.88%)
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 39 (12.82%)
    1 / 41 (2.44%)
    3 / 32 (9.38%)
    1 / 30 (3.33%)
         occurrences all number
    5
    1
    3
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    12 / 39 (30.77%)
    18 / 41 (43.90%)
    10 / 32 (31.25%)
    9 / 30 (30.00%)
         occurrences all number
    12
    18
    10
    9
    Hyperkalaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    5 / 41 (12.20%)
    4 / 32 (12.50%)
    4 / 30 (13.33%)
         occurrences all number
    2
    5
    4
    4
    Hypertriglyceridemia
         subjects affected / exposed
    14 / 39 (35.90%)
    21 / 41 (51.22%)
    22 / 32 (68.75%)
    16 / 30 (53.33%)
         occurrences all number
    14
    21
    22
    16
    Hyperuricemia
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 41 (7.32%)
    8 / 32 (25.00%)
    7 / 30 (23.33%)
         occurrences all number
    3
    3
    8
    7
    Hypoalbuminemia
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 41 (7.32%)
    0 / 32 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    3
    3
    0
    3
    Hypocalcemia
         subjects affected / exposed
    4 / 39 (10.26%)
    3 / 41 (7.32%)
    3 / 32 (9.38%)
    2 / 30 (6.67%)
         occurrences all number
    4
    3
    3
    2
    Hypoglycemia
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 41 (7.32%)
    1 / 32 (3.13%)
    4 / 30 (13.33%)
         occurrences all number
    1
    3
    1
    4
    Hyponatremia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 41 (4.88%)
    3 / 32 (9.38%)
    1 / 30 (3.33%)
         occurrences all number
    2
    2
    3
    1
    Hypophosphatemia
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 41 (7.32%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences all number
    0
    3
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2008
    Clarify recurrence or second cancer.
    23 Mar 2009
    Make minor correction to the protocol and update according to the new investigator brochure.
    19 Oct 2009
    Update IFCT address.
    10 Mar 2010
    Make minor correction to the protocol and update according to the new investigator brochure.
    22 Oct 2010
    Update statistical section following recommendations of the independent data monitoring committee (IDMC) to perform ITT analyses.
    29 Dec 2010
    Reduce the pazopanib dose to 400 mg/day given insufficient compliance as recommended by IDMC and increase the number of inclusions as the recruitment of 31 additional patients in each arm is necessary to evaluate compliance.

    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/28327934
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