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    Clinical Trial Results:
    A multicentre phase III randomised double blind placebo controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancer

    Summary
    EudraCT number
    2005-005821-71
    Trial protocol
    GB  
    Global end of trial date
    13 Nov 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Oct 2016
    First version publication date
    13 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UCL/05/129
    Additional study identifiers
    ISRCTN number
    ISRCTN56306957
    US NCT number
    NCT00433498
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower Street, London, United Kingdom, WC1E 6BT
    Public contact
    Trial Coordinator, Cancer Research UK & UCL Cancer Trials Centre, 0044 02076799747, ctc.lungstar@ucl.ac.uk
    Scientific contact
    Trial Coordinator, Cancer Research UK & UCL Cancer Trials Centre, 0044 02076799974, ctc.lungstar@ucl.ac.uk
    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
    30 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine in patients with SCLC if survival is affected by the addition of pravastatin to either cisplatin/etoposide or carboplatin/etoposide.
    Protection of trial subjects
    Dose modification guidance in place to allow for dose reductions. Guidance for management of adverse events in place Regular assessments of adverse events during treatment and follow-up
    Background therapy
    None
    Evidence for comparator
    All patients were randomised to receive either 'chemotherapy and pravastatin' OR 'chemotherapy and placebo'. The choice of chemotherapy (either cisplatin and etoposide OR carboplatin and etoposide) was determined as per local practice and are the standard drugs used in this patient population.
    Actual start date of recruitment
    19 Feb 2007
    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
    United Kingdom: 846
    Worldwide total number of subjects
    846
    EEA total number of subjects
    846
    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)
    412
    From 65 to 84 years
    432
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    All patients were recruited between 19 February 2007 and 31/01/2012

    Pre-assignment
    Screening details
    All screening assessments were performed up to 21 days prior to randomisation (CT scan were performed up to 31 days prior to randomisation).

    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
    Investigator, Monitor, Carer, Assessor, Subject
    Blinding implementation details
    Use of a matched placebo

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Pravastatin
    Arm description
    Chemotherapy (cisplatin and etoposide or carboplatin and etoposide) + pravastatin
    Arm type
    Active comparator

    Investigational medicinal product name
    cisplatin or carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    According to local guidelines - for a maximum of 6 cycles

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft, Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    According to local guidelines - for a maximum of 6 cycles

    Investigational medicinal product name
    Pravastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg daily for a maximum of 24 months.

    Arm title
    Placebo
    Arm description
    Matched placebo
    Arm type
    Placebo

    Investigational medicinal product name
    cisplatin or carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    According to local guidelines - for a maximum of 6 cycles

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft, Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    According to local guidelines - for a maximum of 6 cycles

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily for a maximum of 24 months.

    Number of subjects in period 1
    Pravastatin Placebo
    Started
    422
    424
    Completed
    422
    424

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pravastatin
    Reporting group description
    Chemotherapy (cisplatin and etoposide or carboplatin and etoposide) + pravastatin

    Reporting group title
    Placebo
    Reporting group description
    Matched placebo

    Reporting group values
    Pravastatin Placebo Total
    Number of subjects
    422 424 846
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    200 212 412
        From 65-84 years
    221 211 432
        85 years and over
    1 1 2
    Gender categorical
    Units: Subjects
        Female
    203 210 413
        Male
    219 214 433

    End points

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    End points reporting groups
    Reporting group title
    Pravastatin
    Reporting group description
    Chemotherapy (cisplatin and etoposide or carboplatin and etoposide) + pravastatin

    Reporting group title
    Placebo
    Reporting group description
    Matched placebo

    Primary: Overall Survival

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    End point title
    Overall Survival
    End point description
    End point type
    Primary
    End point timeframe
    01/10/2015
    End point values
    Pravastatin Placebo
    Number of subjects analysed
    422
    424
    Units: Subjects
        Dead
    381
    377
    Attachments
    Overall survival
    Statistical analysis title
    Hazard ratio
    Comparison groups
    Pravastatin v Placebo
    Number of subjects included in analysis
    846
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    1.16

    Secondary: Progression Free Survival

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    End point title
    Progression Free Survival
    End point description
    Progressed or died.
    End point type
    Secondary
    End point timeframe
    01/10/2015
    End point values
    Pravastatin Placebo
    Number of subjects analysed
    422
    424
    Units: Subjects
        Progressed
    395
    392
    Attachments
    Progression-free survival
    Statistical analysis title
    Hazard ratio
    Comparison groups
    Pravastatin v Placebo
    Number of subjects included in analysis
    846
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.81
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    1.13

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent and 28 days post last trial treatment administration
    Adverse event reporting additional description
    01/10/2015
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Pravastatin
    Reporting group description
    Chemotherapy (cisplatin and etoposide or carboplatin and etoposide) + pravastatin

    Reporting group title
    Placebo
    Reporting group description
    Matched placebo

    Serious adverse events
    Pravastatin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    221 / 422 (52.37%)
    213 / 424 (50.24%)
         number of deaths (all causes)
    381
    377
         number of deaths resulting from adverse events
    2
    0
    Vascular disorders
    Peripheral arterial ischemia
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis/thrombus/embolism
         subjects affected / exposed
    14 / 422 (3.32%)
    20 / 424 (4.72%)
         occurrences causally related to treatment / all
    2 / 16
    0 / 21
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    Vascular - other
         subjects affected / exposed
    0 / 422 (0.00%)
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visceral arterial ischemia
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death not associated with CTCAE term
         subjects affected / exposed
    1 / 422 (0.24%)
    5 / 424 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    Fatigue
         subjects affected / exposed
    11 / 422 (2.61%)
    4 / 424 (0.94%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    8 / 422 (1.90%)
    6 / 424 (1.42%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    35 / 422 (8.29%)
    25 / 424 (5.90%)
         occurrences causally related to treatment / all
    1 / 38
    2 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight loss
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Bilirubin
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Arrhythmia - Other
         subjects affected / exposed
    3 / 422 (0.71%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac General - Other
         subjects affected / exposed
    1 / 422 (0.24%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac ischemia/infarction
         subjects affected / exposed
    2 / 422 (0.47%)
    10 / 424 (2.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hypotension
         subjects affected / exposed
    1 / 422 (0.24%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular systolic dysfunction
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular arrhythmia
         subjects affected / exposed
    10 / 422 (2.37%)
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Valvular heart disease
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasovagal episode
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ARDS
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 422 (0.24%)
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnea
         subjects affected / exposed
    23 / 422 (5.45%)
    26 / 424 (6.13%)
         occurrences causally related to treatment / all
    0 / 25
    1 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypoxia
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 422 (0.71%)
    4 / 424 (0.94%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 422 (0.47%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 422 (0.24%)
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary - Other
         subjects affected / exposed
    3 / 422 (0.71%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood - other
         subjects affected / exposed
    0 / 422 (0.00%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin
         subjects affected / exposed
    24 / 422 (5.69%)
    26 / 424 (6.13%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 32
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhage
         subjects affected / exposed
    4 / 422 (0.95%)
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhage pulmonary
         subjects affected / exposed
    4 / 422 (0.95%)
    5 / 424 (1.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhage, GI
         subjects affected / exposed
    4 / 422 (0.95%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INR (Int. normalized ratio of prothrombin time)
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytes
         subjects affected / exposed
    7 / 422 (1.66%)
    5 / 424 (1.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatics - Other
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophils
         subjects affected / exposed
    32 / 422 (7.58%)
    27 / 424 (6.37%)
         occurrences causally related to treatment / all
    0 / 36
    0 / 31
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Oedema: head and neck
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema: limb
         subjects affected / exposed
    0 / 422 (0.00%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelets
         subjects affected / exposed
    16 / 422 (3.79%)
    12 / 424 (2.83%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CNS ischemia
         subjects affected / exposed
    3 / 422 (0.71%)
    4 / 424 (0.94%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disturbance
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusion
         subjects affected / exposed
    14 / 422 (3.32%)
    9 / 424 (2.12%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    7 / 422 (1.66%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mood alteration
         subjects affected / exposed
    2 / 422 (0.47%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurology - Other
         subjects affected / exposed
    3 / 422 (0.71%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy: cranial
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy-motor
         subjects affected / exposed
    2 / 422 (0.47%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy-sensory
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Personality
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    6 / 422 (1.42%)
    8 / 424 (1.89%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech impairment
         subjects affected / exposed
    1 / 422 (0.24%)
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope (fainting)
         subjects affected / exposed
    4 / 422 (0.95%)
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    6 / 422 (1.42%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    5 / 422 (1.18%)
    11 / 424 (2.59%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    3 / 422 (0.71%)
    8 / 424 (1.89%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Diarrhoea
         subjects affected / exposed
    19 / 422 (4.50%)
    15 / 424 (3.54%)
         occurrences causally related to treatment / all
    2 / 20
    4 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    5 / 422 (1.18%)
    7 / 424 (1.65%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Esophagitis
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GI - other
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    heartburn
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis (clinical exam)
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis (functional/symptomatic)
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    13 / 422 (3.08%)
    13 / 424 (3.07%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction GI
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 422 (0.00%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stricture, Gianotti-Crosti syndrome
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Taste alteration
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer, GI
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    24 / 422 (5.69%)
    19 / 424 (4.48%)
         occurrences causally related to treatment / all
    3 / 28
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary - Other
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver dysfunction
         subjects affected / exposed
    0 / 422 (0.00%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Fistula, GU
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Perforation, GU
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal - Other
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary frequency
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 422 (0.00%)
    4 / 424 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture
         subjects affected / exposed
    0 / 422 (0.00%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle weakness
         subjects affected / exposed
    4 / 422 (0.95%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal - Other
         subjects affected / exposed
    4 / 422 (0.95%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Antidiuretic hormone
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    CPK
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hypercalcemia
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycemia
         subjects affected / exposed
    2 / 422 (0.47%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycemia
         subjects affected / exposed
    1 / 422 (0.24%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalemia
         subjects affected / exposed
    4 / 422 (0.95%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypernatremia
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesemia
         subjects affected / exposed
    0 / 422 (0.00%)
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatremia
         subjects affected / exposed
    8 / 422 (1.90%)
    6 / 424 (1.42%)
         occurrences causally related to treatment / all
    0 / 11
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolic/Lab - Other
         subjects affected / exposed
    0 / 422 (0.00%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Colitis, infectious
         subjects affected / exposed
    2 / 422 (0.47%)
    0 / 424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    22 / 422 (5.21%)
    18 / 424 (4.25%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infection - other
         subjects affected / exposed
    41 / 422 (9.72%)
    52 / 424 (12.26%)
         occurrences causally related to treatment / all
    0 / 48
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infection (clinically documented)
         subjects affected / exposed
    29 / 422 (6.87%)
    31 / 424 (7.31%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 31
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Infection with normal ANC
         subjects affected / exposed
    12 / 422 (2.84%)
    4 / 424 (0.94%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection with unknown ANC
         subjects affected / exposed
    1 / 422 (0.24%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection, opportunistic
         subjects affected / exposed
    5 / 422 (1.18%)
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Pravastatin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    392 / 422 (92.89%)
    401 / 424 (94.58%)
    Investigations
    Thrombocytopenia
    Additional description: CTCAE v3.0 - SOC = coagulation Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    156 / 422 (36.97%)
    141 / 424 (33.25%)
         occurrences all number
    156
    141
    Elevated ALT / AST
    Additional description: CTCAE v3.0- SOC = Metabolic / laboratory Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    118 / 422 (27.96%)
    122 / 424 (28.77%)
         occurrences all number
    118
    122
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
    Additional description: CTCAE v3.0 - SOC = Pulmonary / upper respiratory Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    145 / 422 (34.36%)
    148 / 424 (34.91%)
         occurrences all number
    145
    148
    Cough
    Additional description: CTCAE v3.0 - SOC = Pulmonary / upper respiratory Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    125 / 422 (29.62%)
    115 / 424 (27.12%)
         occurrences all number
    125
    115
    Blood and lymphatic system disorders
    Anaemia
    Additional description: CTCAE v3.03 - SOC = Blood / bone marrow Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    309 / 422 (73.22%)
    0 / 424 (0.00%)
         occurrences all number
    309
    0
    Neutropenia
    Additional description: CTCAE v3.0 - SOC = Blood / bone marrow Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    293 / 422 (69.43%)
    296 / 424 (69.81%)
         occurrences all number
    293
    296
    Leukopenia
    Additional description: CTCAE v3.0 - SOC = Blood / bone marrow Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    216 / 422 (51.18%)
    209 / 424 (49.29%)
         occurrences all number
    216
    209
    Nervous system disorders
    Dizziness
    Additional description: CTCAE v3.0 - SOC = Neurology Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    51 / 422 (12.09%)
    40 / 424 (9.43%)
         occurrences all number
    51
    40
    Neuropathy
    Additional description: CTCAE v3.0 - SOC = neurology Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    44 / 422 (10.43%)
    52 / 424 (12.26%)
         occurrences all number
    44
    52
    General disorders and administration site conditions
    Fatigue
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    287 / 422 (68.01%)
    273 / 424 (64.39%)
         occurrences all number
    287
    273
    Pain
    Additional description: CTCAE v3.0 - SOC = pain Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    235 / 422 (55.69%)
    221 / 424 (52.12%)
         occurrences all number
    235
    221
    Gastrointestinal disorders
    Nausea
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    241 / 422 (57.11%)
    231 / 424 (54.48%)
         occurrences all number
    241
    231
    Constipation
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    214 / 422 (50.71%)
    187 / 424 (44.10%)
         occurrences all number
    214
    187
    Anorexia
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    196 / 422 (46.45%)
    148 / 424 (34.91%)
         occurrences all number
    196
    148
    Mucositis/Stomatitis
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    193 / 422 (45.73%)
    149 / 424 (35.14%)
         occurrences all number
    193
    149
    Vomiting
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    139 / 422 (32.94%)
    123 / 424 (29.01%)
         occurrences all number
    139
    123
    Diarrhoea
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    113 / 422 (26.78%)
    115 / 424 (27.12%)
         occurrences all number
    113
    115
    Renal and urinary disorders
    Renal
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    43 / 422 (10.19%)
    53 / 424 (12.50%)
         occurrences all number
    43
    53
    Skin and subcutaneous tissue disorders
    Alopecia
    Additional description: CTCAE v3.0 - SOC = dermatology Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    148 / 422 (35.07%)
    146 / 424 (34.43%)
         occurrences all number
    148
    146
    Urticaria
    Additional description: CTCAE v3.0 - SOC = Dermatology / skin Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    45 / 422 (10.66%)
    62 / 424 (14.62%)
         occurrences all number
    45
    62
    Musculoskeletal and connective tissue disorders
    Myalgia / myositis
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    74 / 422 (17.54%)
    77 / 424 (18.16%)
         occurrences all number
    74
    77
    Infections and infestations
    Infection
    Additional description: Occurrences not reported. Value displayed is the number of patients affected
         subjects affected / exposed
    248 / 422 (58.77%)
    276 / 424 (65.09%)
         occurrences all number
    248
    276

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Aug 2004
    Correction of drug name - lipostat to pravastatin
    06 Sep 2006
    Consent form – Changing date and version number of PIS in consent form
    29 Jan 2007
    - EDTA and C&G method included for measuring GFR formula and WRIGHT formula removed, and “GFR > 50mls/min as measured by EDTA OR GFR > 40mls/min as measured by the C&G formula” included - Stratification: “and by participating site” removed - Baseline supply clarified “3 months of pravastatin or placebo (3 x 30 tablets)”. - GFR to be capped at 130ml/min with maximum Carboplatin dose of 1000mg
    27 Nov 2007
    Addition of a patient card
    22 Jun 2009
    - Inclusion criteria - Change: The timing of the baseline CT scan has been increased from 28 to 31days - Inclusion criteria - a definition has been added of what is consider limited disease within this trial. - Exclusion criteria - The wording in this section has been changed to clarify that patients are only ineligible when the LFTs reach 3 x ULN. - Exclusion criteria - a sentence has been added, to state that patients who have received methotrexate for arthritis can be entered into the trial. - A list has been added for all the data that is required at the time of randomisation and one for data that is required, but acceptable to send post randomisation. - Dose modifications - The ANC level at which to delay chemotherapy for a week has been changed to <1.0 ANC as a lower limit, with provision for sites to use <1.5 as a cut off point if this is as per local practice. - Criteria for stopping pravastatin/placebo - a paragraph has been added to make it clear that a patient can restart the pravastatin/placebo after a period off study drug.
    19 Sep 2011
    Following receipt of the MHRA Safety Update volume 5, issue 2, September 2011, giving new information on the risk of rhabdomyolysis should fusidic acid be used in combination with statins, all sites were advise that fusidic acid must not be used concurrently with pravastatin. Sites were asked to check whether any LungStar patients were being prescribed fusidic acid and, if so, to take action to temporarily stop pravastatin for a minimum of 7 days after stopping fusidic acid. The protocol, Patient Information Sheet (PIS), GP Letter and Patient Card were updated in line with the guidance from the MHRA Safety Update.

    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.
    AEs reported at each assessment was based on worst grade observed. Occurrences not reported for Adverse Events. Value displayed is the number of patients affected
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