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    Clinical Trial Results:
    A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma

    Summary
    EudraCT number
    		 2008-006344-19
    Trial protocol
    		 DE   GB   CZ   FR   SE   HU   ES   NL  
    Global end of trial date
    20 Nov 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2016
    First version publication date
    22 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1532C00006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Charter Way, Macclesfield, United Kingdom, SK10 2NA
    Public contact
    Gabriella Mariani, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Gabriella Mariani, AstraZeneca, ClinicalTrialTransparency@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
    20 Nov 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the efficacy in terms of OS of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first-line patients with BRAF mutation-positive advanced cutaneous or unknown primary melanoma.
    Protection of trial subjects
    Patients were to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure was anticipated
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 6
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Norway: 5
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    91
    EEA total number of subjects
    71
    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)
    67
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Tumour evaluation and confirmation of BRAF mutation status using patient’s tumour sample, serum and plasma sample for extraction of cfDNA, demography, medical and surgical history, previous anti-cancer treatment, disease staging, smoking status, height, eligibility check.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 selumetinib 75mg BD +dacarbazine
    Arm description
    		 selumetinib 75mg twice daily + Dacarbazine
    Arm type
    		 Experimental

    Investigational medicinal product name
    selumetinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    75mg BD

    Arm title
    		 Placebo BD + Dacarbazine
    Arm description
    		 Placebo twice daily + Dacarbazine
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    BD

    Number of subjects in period 1
    		selumetinib 75mg BD +dacarbazine Placebo BD + Dacarbazine
    Started
    45
    46
    Received Treatment
    44
    45
    Completed
    44
    45
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    selumetinib 75mg BD +dacarbazine
    Reporting group description
    		 selumetinib 75mg twice daily + Dacarbazine

    Reporting group title
    Placebo BD + Dacarbazine
    Reporting group description
    		 Placebo twice daily + Dacarbazine

    Reporting group values
    		 selumetinib 75mg BD +dacarbazine Placebo BD + Dacarbazine Total
    Number of subjects
    		 45 46 91
    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)
    		 32 35 67
        From 65-84 years
    		 13 11 24
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 55.7 ± 14.89 51.6 ± 16.21 -
    Gender, Male/Female
    Units: Participants
        Female
    		 23 18 41
        Male
    		 22 28 50
    Subject analysis sets

    Subject analysis set title
    selumetinib 75mg BD + dacarbazine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    selumetinib 75mg twice daily + dacarbazine

    Subject analysis set title
    Placebo + dacarbazine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matched Placebo + dacarbazine

    Subject analysis sets values
    		 selumetinib 75mg BD + dacarbazine Placebo + dacarbazine
    Number of subjects
    45
    46
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    32
    35
        From 65-84 years
    13
    11
        85 years and over
    0
    0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    55.7 ± 14.89
    51.6 ± 16.21
    Gender, Male/Female
    Units: Participants
        Female
    23
    18
        Male
    22
    28

    End points

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    End points reporting groups
    Reporting group title
    selumetinib 75mg BD +dacarbazine
    Reporting group description
    		 selumetinib 75mg twice daily + Dacarbazine

    Reporting group title
    Placebo BD + Dacarbazine
    Reporting group description
    		 Placebo twice daily + Dacarbazine

    Subject analysis set title
    selumetinib 75mg BD + dacarbazine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    selumetinib 75mg twice daily + dacarbazine

    Subject analysis set title
    Placebo + dacarbazine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matched Placebo + dacarbazine

    Primary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Time from randomization to death due to any cause
    End point type
    Primary
    End point timeframe
    Randomzation to data cutoff
    End point values
    		 selumetinib 75mg BD + dacarbazine Placebo + dacarbazine
    Number of subjects analysed
    45
    46
    Units: Days
        median (full range (min-max))
    424 (63 to 760)
    321 (66 to 739)
    Statistical analysis title
    		 Overall Survival Analysis
    Statistical analysis description
    If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.
    Comparison groups
    selumetinib 75mg BD + dacarbazine v Placebo + dacarbazine
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3873 [1]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.28
    Notes
    [1] - 1-sided p-value

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    Time from randomization to objective disease progression, according to RECIST 1.0, or death.
    End point type
    Secondary
    End point timeframe
    Randomization to data cutoff
    End point values
    		 selumetinib 75mg BD + dacarbazine Placebo + dacarbazine
    Number of subjects analysed
    45
    46
    Units: Days
        median (full range (min-max))
    169 (37 to 596)
    92 (32 to 660)
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Patients classified as a responder have a best response of partial response of complete response as per RECIST 1.0
    End point type
    Secondary
    End point timeframe
    randomization up to and including PFS event
    End point values
    		 selumetinib 75mg BD + dacarbazine Placebo + dacarbazine
    Number of subjects analysed
    45
    46
    Units: Participants
        Response
    18
    12
        Complete Response
    1
    1
        Partial Response
    17
    11
        Non-response
    27
    34
        Stable Disease >=6 weeks
    13
    10
        Progression
    14
    24
    No statistical analyses for this end point

    Secondary: Change in target lesion tumour size at week 12

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    End point title
    		 Change in target lesion tumour size at week 12
    End point description
    End point type
    Secondary
    End point timeframe
    randomization to week 12
    End point values
    		 selumetinib 75mg BD + dacarbazine Placebo + dacarbazine
    Number of subjects analysed
    45
    46
    Units: % change
        median (full range (min-max))
    -8.85 (-65.22 to 121.77)
    0.22 (-72.5 to 295.79)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Following randomisation on Day 1 until 30 days after the last dose of the last study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Placebo BD + Dacarbazine
    Reporting group description
    		 Placebo twice daily + Dacarbazine

    Reporting group title
    selumetinib 75mg BD +dacarbazine
    Reporting group description
    		 selumetinib 75mg twice daily + Dacarbazine

    Serious adverse events
    		 Placebo BD + Dacarbazine selumetinib 75mg BD +dacarbazine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 45 (17.78%)
    22 / 44 (50.00%)
         number of deaths (all causes)
    34
    30
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intracranial tumour haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial thrombosis limb
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Left atrial dilatation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Febrile neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Periorbital oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Groin Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BD + Dacarbazine selumetinib 75mg BD +dacarbazine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 45 (97.78%)
    44 / 44 (100.00%)
    Vascular disorders
    HYPERTENSION
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    8 / 44 (18.18%)
         occurrences all number
    1
    9
    LYMPHOEDEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    11 / 44 (25.00%)
         occurrences all number
    2
    11
    General disorders and administration site conditions
    ASTHENIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 45 (11.11%)
    12 / 44 (27.27%)
         occurrences all number
    8
    22
    CHILLS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 44 (6.82%)
         occurrences all number
    1
    4
    FACE OEDEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 44 (6.82%)
         occurrences all number
    1
    4
    GENERALISED OEDEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    6 / 44 (13.64%)
         occurrences all number
    2
    7
    FATIGUE
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 45 (33.33%)
    16 / 44 (36.36%)
         occurrences all number
    23
    21
    OEDEMA PERIPHERAL
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 45 (6.67%)
    19 / 44 (43.18%)
         occurrences all number
    3
    27
    LOCALISED OEDEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    4
    PYREXIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 45 (11.11%)
    5 / 44 (11.36%)
         occurrences all number
    9
    8
    Respiratory, thoracic and mediastinal disorders
    COUGH
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    3 / 44 (6.82%)
         occurrences all number
    4
    3
    DYSPNOEA EXERTIONAL
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 45 (13.33%)
    8 / 44 (18.18%)
         occurrences all number
    7
    10
    EPISTAXIS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 44 (6.82%)
         occurrences all number
    1
    4
    DYSPNOEA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    3 / 44 (6.82%)
         occurrences all number
    2
    3
    Psychiatric disorders
    ANXIETY
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 45 (11.11%)
    5 / 44 (11.36%)
         occurrences all number
    5
    5
    BRADYPHRENIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    DEPRESSION
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    3 / 44 (6.82%)
         occurrences all number
    2
    3
    INSOMNIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 45 (6.67%)
    3 / 44 (6.82%)
         occurrences all number
    3
    3
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    3 / 45 (6.67%)
    4 / 44 (9.09%)
         occurrences all number
    3
    4
    BLOOD CREATININE PHOSPHOKINASE INCREASED
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    7 / 44 (15.91%)
         occurrences all number
    0
    9
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    5 / 44 (11.36%)
         occurrences all number
    1
    6
    BLOOD PRESSURE INCREASED
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    5
    WEIGHT INCREASED
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    Nervous system disorders
    DIZZINESS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    6 / 44 (13.64%)
         occurrences all number
    2
    12
    DYSGEUSIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    4 / 44 (9.09%)
         occurrences all number
    4
    4
    HEADACHE
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 45 (26.67%)
    5 / 44 (11.36%)
         occurrences all number
    17
    6
    LETHARGY
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    2 / 44 (4.55%)
         occurrences all number
    4
    2
    PARAESTHESIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    3 / 44 (6.82%)
         occurrences all number
    6
    3
    SYNCOPE
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    Blood and lymphatic system disorders
    ANAEMIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 44 (9.09%)
         occurrences all number
    2
    4
    LEUKOPENIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 45 (6.67%)
    1 / 44 (2.27%)
         occurrences all number
    3
    2
    Thrombocytopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 45 (13.33%)
    11 / 44 (25.00%)
         occurrences all number
    9
    19
    NEUTROPENIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 45 (15.56%)
    7 / 44 (15.91%)
         occurrences all number
    11
    19
    Eye disorders
    PERIORBITAL OEDEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 44 (9.09%)
         occurrences all number
    1
    4
    EYELID OEDEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    4
    Gastrointestinal disorders
    Abdominal Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    9 / 44 (20.45%)
         occurrences all number
    4
    10
    Abdominal Pain Upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    4 / 44 (9.09%)
         occurrences all number
    4
    4
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 45 (28.89%)
    12 / 44 (27.27%)
         occurrences all number
    19
    18
    DIARRHOEA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 45 (28.89%)
    21 / 44 (47.73%)
         occurrences all number
    18
    46
    DRY MOUTH
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    6 / 44 (13.64%)
         occurrences all number
    0
    6
    DYSPEPSIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    6 / 44 (13.64%)
         occurrences all number
    3
    6
    FLATULENCE
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 45 (11.11%)
    1 / 44 (2.27%)
         occurrences all number
    5
    1
    GASTROOESOPHAGEAL REFLUX DISEASE
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    STOMATITIS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 45 (11.11%)
    8 / 44 (18.18%)
         occurrences all number
    6
    10
    NAUSEA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    25 / 45 (55.56%)
    28 / 44 (63.64%)
         occurrences all number
    48
    57
    VOMITING
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 45 (31.11%)
    20 / 44 (45.45%)
         occurrences all number
    22
    39
    Skin and subcutaneous tissue disorders
    DERMATITIS ACNEIFORM
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    23 / 44 (52.27%)
         occurrences all number
    1
    32
    DRY SKIN
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    10 / 44 (22.73%)
         occurrences all number
    2
    12
    ECZEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    5 / 44 (11.36%)
         occurrences all number
    1
    6
    ERYTHEMA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 44 (9.09%)
         occurrences all number
    1
    5
    EXFOLIATIVE RASH
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 44 (6.82%)
         occurrences all number
    4
    2
    HAIR COLOUR CHANGES
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    NIGHT SWEATS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    3 / 44 (6.82%)
         occurrences all number
    4
    3
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    5 / 44 (11.36%)
         occurrences all number
    0
    6
    PRURITUS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    3 / 44 (6.82%)
         occurrences all number
    3
    3
    SKIN CHAPPED
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    5
    SKIN FISSURES
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    ALOPECIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    6 / 44 (13.64%)
         occurrences all number
    2
    6
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 45 (6.67%)
    4 / 44 (9.09%)
         occurrences all number
    3
    5
    BACK PAIN
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 45 (6.67%)
    7 / 44 (15.91%)
         occurrences all number
    4
    7
    MYALGIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 44 (6.82%)
         occurrences all number
    1
    5
    PAIN IN EXTREMITY
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 45 (8.89%)
    3 / 44 (6.82%)
         occurrences all number
    5
    3
    Infections and infestations
    FOLLICULITIS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    5 / 44 (11.36%)
         occurrences all number
    0
    6
    PARONYCHIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    6 / 44 (13.64%)
         occurrences all number
    0
    8
    NASOPHARYNGITIS
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 45 (13.33%)
    3 / 44 (6.82%)
         occurrences all number
    7
    5
    RASH PUSTULAR
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    6 / 44 (13.64%)
         occurrences all number
    0
    7
    UPPER RESPIRATORY TRACT INFECTION
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 44 (9.09%)
         occurrences all number
    4
    5
    URINARY TRACT INFECTION
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    5 / 44 (11.36%)
         occurrences all number
    0
    9
    Metabolism and nutrition disorders
    DECREASED APPETITE
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 45 (24.44%)
    10 / 44 (22.73%)
         occurrences all number
    13
    11
    HYPOKALAEMIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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