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    Clinical Trial Results:
    A randomised placebo-controlled trial of saracatinib (AZD0530) plus weekly paclitaxel in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.

    Summary
    EudraCT number
    		 2009-017171-13
    Trial protocol
    		 GB  
    Global end of trial date
    12 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2017
    First version publication date
    25 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UCL/09/0105
    Additional study identifiers
    ISRCTN number
    		 ISRCTN32163062
    US NCT number
    		 NCT01196741
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Joint Research Office, Gower Street, London, United Kingdom, WC1E 6BT
    Public contact
    Mr Lee Webber, Cancer Research UK & UCL Cancer Trials Centre, 44 2076799872, ctc.sapproc@ucl.ac.uk
    Scientific contact
    Mr Lee Webber, Cancer Research UK & UCL Cancer Trials Centre, 44 2076799872, ctc.sapproc@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
    31 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research question was to see whether adding the drug saracatinib to weekly paclitaxel chemotherapy improves 6 month progression-free survival in patients with platinum-resistant ovarian cancer.
    Protection of trial subjects
    Protection included risk assessment, on-site monitoring, dose modifications and emergency unblinding procedure.
    Background therapy
    		 Not applicable, both saracatinib (and matched placebo) and paclitaxel were classed as IMP
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    11 Apr 2011
    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: 107
    Worldwide total number of subjects
    107
    EEA total number of subjects
    107
    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)
    62
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 107 patients were randomised from 12 UK sites between April 2011 and May 2012

    Pre-assignment
    Screening details
    		 Patients were recruited following successful screening, according to pre-specified protocol eligibility criteria and baseline assessments

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Blinding via Interactive Web-based Randomisation System (IWRS). Sites were provided with a detailed unblinding procedure

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Weekly paclitaxel plus saracatinib
    Arm description
    		 Weekly paclitaxel plus saracatinib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Full dose of 80mg per metre squared, with dose reductions to 70mg and 60mg per metre squared - 8 weekly cycles whereby paclitaxel given weekly for 6 weeks followed by a 2 week rest

    Investigational medicinal product name
    Saracatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    175 mg daily, commencing 7 days prior to start of weekly paclitaxel - daily until disease progression

    Arm title
    		 Weekly paclitaxel plus placebo
    Arm description
    		 Weekly paclitaxel plus placebo
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Full dose of 80mg per metre squared, with dose reductions to 70mg and 60mg per metre squared - 8 weekly cycles whereby paclitaxel given weekly for 6 weeks followed by a 2 week rest

    Investigational medicinal product name
    Matched placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commencing 7 days prior to start of weekly paclitaxel - daily until disease progression

    Number of subjects in period 1
    		Weekly paclitaxel plus saracatinib Weekly paclitaxel plus placebo
    Started
    71
    36
    Completed
    69
    35
    Not completed
    2
    1
         Adverse event, non-fatal
    1
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Weekly paclitaxel plus saracatinib
    Reporting group description
    		 Weekly paclitaxel plus saracatinib

    Reporting group title
    Weekly paclitaxel plus placebo
    Reporting group description
    		 Weekly paclitaxel plus placebo

    Reporting group values
    		 Weekly paclitaxel plus saracatinib Weekly paclitaxel plus placebo Total
    Number of subjects
    		 71 36 107
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 46 16 62
        From 65-84 years
    		 25 20 45
    Age continuous
    Units: years
        median (full range (min-max))
    		 62.8 (34.5 to 78.8) 66.9 (20 to 82.1) -
    Gender categorical
    Units: Subjects
        Female
    		 71 36 107
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat weekly paclitaxel plus saracatinib
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised who took at least one dose of study medication

    Subject analysis set title
    Intention-to-treat weekly paclitaxel plus placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised who took at least one dose of study medication

    Subject analysis sets values
    		 Intention-to-treat weekly paclitaxel plus saracatinib Intention-to-treat weekly paclitaxel plus placebo
    Number of subjects
    69
    35
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    45
    15
        From 65-84 years
    24
    20
    Age continuous
    Units: years
        median (full range (min-max))
    62.4 (34.5 to 78.8)
    67 (47.4 to 82.1)
    Gender categorical
    Units: Subjects
        Female
    69
    35
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Weekly paclitaxel plus saracatinib
    Reporting group description
    		 Weekly paclitaxel plus saracatinib

    Reporting group title
    Weekly paclitaxel plus placebo
    Reporting group description
    		 Weekly paclitaxel plus placebo

    Subject analysis set title
    Intention-to-treat weekly paclitaxel plus saracatinib
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised who took at least one dose of study medication

    Subject analysis set title
    Intention-to-treat weekly paclitaxel plus placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised who took at least one dose of study medication

    Primary: 6 month progression-free survival (PFS) rate

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    End point title
    		 6 month progression-free survival (PFS) rate
    End point description
    End point type
    Primary
    End point timeframe
    The number and proportion of patients who are alive and progression free at 6 months from randomisation
    End point values
    		 Intention-to-treat weekly paclitaxel plus saracatinib Intention-to-treat weekly paclitaxel plus placebo
    Number of subjects analysed
    69
    35
    Units: Number of patients
    20
    12
    Statistical analysis title
    		 Primary endpoint statistical analysis
    Comparison groups
    Intention-to-treat weekly paclitaxel plus placebo v Intention-to-treat weekly paclitaxel plus saracatinib
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.589
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Median overall survival (OS)

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    End point title
    		 Median overall survival (OS)
    End point description
    End point type
    Secondary
    End point timeframe
    The period of time between the date of randomisation to date of death
    End point values
    		 Intention-to-treat weekly paclitaxel plus saracatinib Intention-to-treat weekly paclitaxel plus placebo
    Number of subjects analysed
    69
    35
    Units: Months
        median (full range (min-max))
    10.1 (8.3 to 16.2)
    12.3 (11 to 14.4)
    No statistical analyses for this end point

    Secondary: Median progression free survival (PFS)

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    End point title
    		 Median progression free survival (PFS)
    End point description
    End point type
    Secondary
    End point timeframe
    Defined as the date from randomisation to the date of first progression or death (whichever occurs first)
    End point values
    		 Intention-to-treat weekly paclitaxel plus saracatinib Intention-to-treat weekly paclitaxel plus placebo
    Number of subjects analysed
    69
    35
    Units: Months
        median (full range (min-max))
    4.7 (3.6 to 5.5)
    5.3 (3.6 to 7.2)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (combined RECIST v1.1 & GCIG CA125 criteria)

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    End point title
    		 Objective Response Rate (combined RECIST v1.1 & GCIG CA125 criteria)
    End point description
    The number of patients with a documented complete response (CR) or partial response (PR) according to combined RECIST v1.1 & GCIG CA125 criteria
    End point type
    Secondary
    End point timeframe
    According to protocol-specified schedule. Radiological imaging: baseline, during the rest period of each chemotherapy cycle, 3 monthly during follow up until progression. CA125: baseline, weeks 1, 3 and 6 of each chemotherapy cycle, 6 weekly follow up
    End point values
    		 Intention-to-treat weekly paclitaxel plus saracatinib Intention-to-treat weekly paclitaxel plus placebo
    Number of subjects analysed
    69
    35
    Units: Number of patients
    20
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Between informed consent and 30 days post last trial treatment administration
    Adverse event reporting additional description
    The specified serious adverse events are those presented in the published paper i.e. SAEs of grade 3-5 according to CTCAE v4.0
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Weekly paclitaxel plus saracatinib
    Reporting group description
    		 Weekly paclitaxel plus saracatinib

    Reporting group title
    Weekly paclitaxel plus placebo
    Reporting group description
    		 Weekly paclitaxel plus placebo

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The published results did not specify non-serious adverse events, only serious adverse events of grade 3-5 according to CTCAE v4.0. Under each reporting group, 0 has been entered for 'Subjects affected by non-serious adverse events' to enable validation of the results data set. Please refer to the published paper.
    Serious adverse events
    		 Weekly paclitaxel plus saracatinib Weekly paclitaxel plus placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 69 (36.23%)
    11 / 35 (31.43%)
         number of deaths (all causes)
    51
    26
         number of deaths resulting from adverse events
    Investigations
    Neutrophil count decreased
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Creatinine increased
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular arrhythmia
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    3 / 69 (4.35%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    3 / 69 (4.35%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    4 / 69 (5.80%)
    3 / 35 (8.57%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    4 / 69 (5.80%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    3 / 69 (4.35%)
    2 / 35 (5.71%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    3 / 69 (4.35%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Catheter-related infection
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis infective
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal chest infection
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorexia
    Additional description: SAEs of grade 3-5 according to CTCAE v4.0
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Weekly paclitaxel plus saracatinib Weekly paclitaxel plus placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 35 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2012
    Updates and clarifications to protocol

    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
    For support, Contact us.
    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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