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    Clinical Trial Results:
    A Randomised Open-Label Phase II Study to Assess the Efficacy and Safety of AZD4547 Monotherapy versus Paclitaxel in Patients with Advanced Gastric Adenocarcinoma (including Adenocarcinoma of the Lower-Third of the Oesophagus or the Gastro-Oesophageal Junction) with FGFR2 Polysomy or Gene Amplification (Shine study)

    Summary
    EudraCT number
    		 2010-023377-19
    Trial protocol
    		 GB   DE   CZ   ES   BE   IT   HU   BG  
    Global end of trial date
    27 Jun 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2016
    First version publication date
    04 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2610C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astrazeneca
    Sponsor organisation address
    Alderley Park, Cheshire, United Kingdom, SK10 4TG
    Public contact
    Prof Eric Van Cutsem, MD, PhD, University Hospital Gasthuisberg, eric.vancutsem@med.kuleuven.be
    Scientific contact
    Donal Landers, Astra Zeneca, Donal.Landers@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
    17 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Prompted by slow recruitment and concerns about the feasibility of completing enrolment in a realistic timeframe, AstraZeneca and the Safety Review Committee (SRC) for the study agreed that it would be appropriate to conduct an unscheduled analysis of the efficacy (based on average change in tumour size) and tolerability data. The results of this unscheduled analysis did not show superiority of AZD4547 over paclitaxel in patients with advanced gastric cancer tumours that have FGFR2 amplification. Thus, it was concluded that the study was unlikely to meet its primary objective of demonstrating superiority of AZD4547 monotherapy over paclitaxel, based on PFS, and a decision was made to cease enrolment and close the study.
    Protection of trial subjects
    An SRC was appointed to review all available safety data at approximately 2-month intervals.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 17
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    India: 1
    Country: Number of subjects enrolled
    Spain: 13
    Worldwide total number of subjects
    71
    EEA total number of subjects
    42
    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)
    44
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 11 countries. Enrolment started in November 2011 and last patient visit was in August 2013. In total, 960 patients were enrolled out of which 71 were randomised. A total of 67 patients received treatment , 40 of these patients received AZD4547 and 27 received Paclitaxel.

    Pre-assignment
    Screening details
    		 Patients ≥ 25 years with locally advanced or metastatic gastric adenocarcinoma that had FGFR2 polysomy or FGFR2 gene amplification and whose disease had progressed during or after 1st line therapy. Patients whose disease had progressed within 6 months following adjuvant or neo-adjuvant therapy could be included at the discretion of the investigator

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD4547
    Arm description
    		 80mg BD 2 weeks on/1 week off
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD4547
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80mg BD 2 weeks on/1 week off

    Arm title
    		 Paclitaxel
    Arm description
    		 80mg / m**2
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    80mg / m**2

    Number of subjects in period 1
    		AZD4547 Paclitaxel
    Started
    41
    30
    Received treatment
    40
    27
    Did not receive treatment
    1
    3
    Ongoing treatment at data cut-off
    1
    1
    Completed
    0
    0
    Not completed
    41
    30
         Adverse event, serious fatal
    27
    16
         Consent withdrawn by subject
    1
    1
         Death before treatment
    1
    2
         Lost to follow-up
    1
    -
         Did not receive treatment
    -
    1
         Unclassified reason for not completed
    11
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD4547
    Reporting group description
    		 80mg BD 2 weeks on/1 week off

    Reporting group title
    Paclitaxel
    Reporting group description
    		 80mg / m**2

    Reporting group values
    		 AZD4547 Paclitaxel Total
    Number of subjects
    		 41 30 71
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 27 17 44
        From 65-84 years
    		 14 13 27
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ± 11.38 61.9 ± 10.65 -
    Gender, Male/Female
    Gender
    Units: Participants
        Female
    		 12 8 20
        Male
    		 29 22 51
    Age, Customized
    Age by category
    Units: Subjects
        <50 years
    		 7 4 11
        >=50 - < 65 years
    		 20 13 33
        >= 65 years
    		 14 13 27

    End points

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    End points reporting groups
    Reporting group title
    AZD4547
    Reporting group description
    		 80mg BD 2 weeks on/1 week off

    Reporting group title
    Paclitaxel
    Reporting group description
    		 80mg / m**2

    Primary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).
    End point type
    Primary
    End point timeframe
    Week 8 (±1 week) and then every 8 weeks (±1 week)
    End point values
    		 AZD4547 Paclitaxel
    Number of subjects analysed
    38
    30
    Units: Patients
    36
    26
    Statistical analysis title
    		 Progression free survival (Full analysis set)
    Statistical analysis description
    The analysis was performed using a Cox proportional hazards model with factors for treatment and FGFR2 FISH score (4/5 versus 6).
    Comparison groups
    AZD4547 v Paclitaxel
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.9581 [2]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.57
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 2.21
    Notes
    [1] - The 3 patients from the Full analysis set with an FGFR FISH score of 2 or 3 were not included in the analysis.A hazard ratio < 1 favours AZD4547 80mg BD 2 weeks on/1 week off.CI calculated using Profile Likelihood.
    [2] - 1-sided

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8 (±1 week) and then every 8 weeks (±1 week)
    End point values
    		 AZD4547 Paclitaxel
    Number of subjects analysed
    38
    30
    Units: Patients
    27
    18
    Statistical analysis title
    		 Overall Survival
    Comparison groups
    AZD4547 v Paclitaxel
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.8156 [3]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.31
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.95
    Notes
    [3] - 1-sided

    Secondary: Objective Response Rate

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    End point title
    		 Objective Response Rate
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8 (±1 week) and then every 8 weeks (±1 week)
    End point values
    		 AZD4547 Paclitaxel
    Number of subjects analysed
    38
    30
    Units: Patients
    1
    7
    Statistical analysis title
    		 Objective response Rate
    Comparison groups
    AZD4547 v Paclitaxel
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.997 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.09
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.35
    Notes
    [4] - 1-sided

    Secondary: Change in tumour size at 8 weeks

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    End point title
    		 Change in tumour size at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8 (±1 week)
    End point values
    		 AZD4547 Paclitaxel
    Number of subjects analysed
    34
    26
    Units: patients
        geometric mean (geometric coefficient of variation)
    27.5 ± 26.9
    -7 ± 37.3
    Statistical analysis title
    		 Change in tumour size at 8 wks
    Comparison groups
    AZD4547 v Paclitaxel
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.99 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    39.44
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 25.18
         upper limit
    		 55.33
    Notes
    [5] - 1-sided

    Secondary: Mean change in tumour size

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    End point title
    		 Mean change in tumour size
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8 (±1 week)
    End point values
    		 AZD4547 Paclitaxel
    Number of subjects analysed
    36
    26
    Units: Patients
        number (not applicable)
    28.4
    -1.1
    No statistical analyses for this end point

    Secondary: Percentage of patients without progressive disease at 8 weeks

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    End point title
    		 Percentage of patients without progressive disease at 8 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8 (±1 week)
    End point values
    		 AZD4547 Paclitaxel
    Number of subjects analysed
    41
    30
    Units: Patients
    number (not applicable)
        Number of patients
    10
    16
        Percentage of patients
    24.4
    53.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs will be collected throughout the study, from randomisation until the end of the follow-up period. The follow-up period is defined as 28 days after study treatment (AZD4547 or paclitaxel) is discontinued.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Paclitaxel
    Reporting group description
    		 80mg / m**2

    Reporting group title
    AZD4547
    Reporting group description
    		 80mg BD 2 weeks on/1 week off

    Serious adverse events
    		 Paclitaxel AZD4547
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 27 (22.22%)
    8 / 40 (20.00%)
         number of deaths (all causes)
    16
    27
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Blood bilirubin indirect increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
    alternative dictionary used: MedDRA 16
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial disorder
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         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
    Anaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyphagia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting alone
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Obstruction of bile duct
    alternative dictionary used: MedDRA 16
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Biliary tract infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infectio
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 Paclitaxel AZD4547
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 27 (96.30%)
    39 / 40 (97.50%)
    General disorders and administration site conditions
    Asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 27 (18.52%)
    11 / 40 (27.50%)
         occurrences all number
    5
    11
    fatigue
         subjects affected / exposed
    8 / 27 (29.63%)
    6 / 40 (15.00%)
         occurrences all number
    8
    6
    Oedema of extremities
    Additional description: Oedema peripheral
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 40 (10.00%)
         occurrences all number
    2
    4
    Pyrexia
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 40 (10.00%)
         occurrences all number
    2
    4
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    productiveCough
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 40 (5.00%)
         occurrences all number
    3
    2
    Peripheral neuropathy hereditary
    Additional description: Neuropathy periheral
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 40 (2.50%)
         occurrences all number
    4
    1
    Investigations
    aspartate
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 27 (18.52%)
    7 / 40 (17.50%)
         occurrences all number
    0
    7
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 27 (3.70%)
    4 / 40 (10.00%)
         occurrences all number
    1
    4
    Bilirubin value increased
         subjects affected / exposed
    0 / 27 (0.00%)
    5 / 40 (12.50%)
         occurrences all number
    0
    5
    Alanine amonitransferase increased
    Additional description: Alanine amonitransferase increased
         subjects affected / exposed
    1 / 27 (3.70%)
    4 / 40 (10.00%)
         occurrences all number
    1
    4
    Blood phosphorus increase
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    4 / 27 (14.81%)
    6 / 40 (15.00%)
         occurrences all number
    4
    6
    Headache
         subjects affected / exposed
    1 / 27 (3.70%)
    4 / 40 (10.00%)
         occurrences all number
    1
    4
    Dizziness
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Lethargy
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 27 (22.22%)
    7 / 40 (17.50%)
         occurrences all number
    6
    7
    Neutropenia
         subjects affected / exposed
    9 / 27 (33.33%)
    2 / 40 (5.00%)
         occurrences all number
    9
    2
    Eye disorders
    Detachment of macular retinal pigment epithelium
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 27 (0.00%)
    6 / 40 (15.00%)
         occurrences all number
    0
    6
    Dryness of eyes
         subjects affected / exposed
    0 / 27 (0.00%)
    4 / 40 (10.00%)
         occurrences all number
    0
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 27 (22.22%)
    10 / 40 (25.00%)
         occurrences all number
    6
    10
    Constipation
         subjects affected / exposed
    5 / 27 (18.52%)
    10 / 40 (25.00%)
         occurrences all number
    5
    10
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    5 / 27 (18.52%)
    9 / 40 (22.50%)
         occurrences all number
    5
    9
    Vomiting alone
         subjects affected / exposed
    5 / 27 (18.52%)
    8 / 40 (20.00%)
         occurrences all number
    5
    8
    Stomatitis ulcerative
    Additional description: Stomatitis
         subjects affected / exposed
    2 / 27 (7.41%)
    10 / 40 (25.00%)
         occurrences all number
    2
    10
    Abdominal pain upper
         subjects affected / exposed
    0 / 27 (0.00%)
    9 / 40 (22.50%)
         occurrences all number
    0
    9
    Hepatobiliary disorders
    Diarrhoea
         subjects affected / exposed
    6 / 27 (22.22%)
    6 / 40 (15.00%)
         occurrences all number
    6
    6
    Skin and subcutaneous tissue disorders
    Alopecia mucinosa
    Additional description: Alopecia
         subjects affected / exposed
    13 / 27 (48.15%)
    2 / 40 (5.00%)
         occurrences all number
    13
    2
    Dry skin
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Onychomadesis
    Additional description: Onychomadesis
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3
    Nail discolouration
    Additional description: Nail discolouration
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    onycholysis
    Additional description: onycholysis
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 27 (22.22%)
    1 / 40 (2.50%)
         occurrences all number
    6
    1
    Arthralgia
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Urinary tract infectio
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 27 (29.63%)
    16 / 40 (40.00%)
         occurrences all number
    8
    16
    Hyperkalaemia
    Additional description: Hyperkalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Dry mouth
         subjects affected / exposed
    0 / 27 (0.00%)
    9 / 40 (22.50%)
         occurrences all number
    0
    9
    Hyperphosphataemia
    Additional description: Hyperphosphataemia
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2012
    Patients with gastric adenocarcinoma of lower-third of the oesophagus or the Gastro-oesophageal junction were to be included in the study. The phase of the study was modified to Phase II due to increased sample size. Clarification of patient population and re-labelling of the study as Phase II to reflect the increase in study size. Sample size of randomised patients was increased to 160 patients.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Jun 2013
    It was concluded that the study was unlikely to meet its primary objective of demonstrating superiority of AZD4547 monotherapy over paclitaxel, based on PFS, and a decision was made to cease enrolment and close the study.
    -

    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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