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    Clinical Trial Results:
    A Phase I/II randomised, double-blind, multi-centre study to assess the efficacy of AZD2281 when given in combination with paclitaxel in the 1st or 2nd line treatment of patients with metastatic Triple Negative Breast Cancer

    Summary
    EudraCT number
    		 2008-002608-25
    Trial protocol
    		 AT   BE   CZ   DK  
    Global end of trial date
    09 Nov 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2019
    First version publication date
    22 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D0810C00011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85,, Södertälje, Sweden,
    Public contact
    Clinical Trial Transparency Team, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Clinical Trial Transparency Team, 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
    09 Nov 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2009
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the Phase I part of this study was: · To establish the appropriate doses of paclitaxel and AZD2281 in combination, based on safety and tolerability (for use in the randomised Phase II part of the study). The primary objective of the Phase II part of this study was: · To determine the efficacy (assessed by Progression Free Survival [PFS]) of AZD2281 in combination with paclitaxel compared to paclitaxel alone in this patient population.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council on Harmonisation/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2008
    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
    Canada: 3
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 3
    Worldwide total number of subjects
    19
    EEA total number of subjects
    4
    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)
    17
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In the Phase 1 part of this study, 24 patients were enrolled at 6 centres in 4 countries: Australia (3), Austria (1), Belgium (1) and Canada (1). Protocol Amendment 1 was implemented before recruitment of Cohort 2, which introduced the use of a G-CSF for initial management of neutropenia.

    Pre-assignment
    Screening details
    		 In this trial, there was a screening period of 28 days prior to first dose of study treatment. There were 5 patients who were in the pre-assignment period but were not subsequently assigned treatment. This was due to Progression (1), Incorrect enrolment (3) and Voluntary withdrawal (1).

    Pre-assignment period milestones
    Number of subjects started
    		 24 [1]
    Number of subjects completed
    		 19

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Incorrect enrolment: 3
    Reason: Number of subjects
    		 Lack of efficacy: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: There were 5 patients who were in the pre-assignment period but were not subsequently assigned treatment. This was due to Progression (1), Incorrect enrolment (3) and Voluntary withdrawal (1).
    Period 1
    Period 1 title
    Phase I - Safety Run-In (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The Phase I part of this study is open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD2281
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg bd through a 28 day cycle

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    90 mg/m2 IV for 6 to 10 cycles

    Arm title
    		 Cohort 2
    Arm description
    		 Both arms have the same allocated treatment, however Cohort 2 allowed the use of a granulocyte colony stimulating factor (G-CSF; filgrastim) for initial management of neutropenia
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD2281
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg bd through a 28 day cycle

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    90 mg/m2 IV for 6 to 10 cycles

    Number of subjects in period 1
    		Cohort 1 Cohort 2
    Started
    9
    10
    Completed
    1
    3
    Not completed
    8
    7
         Consent withdrawn by subject
    1
    -
         Lack of efficacy
    7
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 -

    Reporting group title
    Cohort 2
    Reporting group description
    		 Both arms have the same allocated treatment, however Cohort 2 allowed the use of a granulocyte colony stimulating factor (G-CSF; filgrastim) for initial management of neutropenia

    Reporting group values
    		 Cohort 1 Cohort 2 Total
    Number of subjects
    		 9 10 19
    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)
    		 8 9 17
        From 65-84 years
    		 1 1 2
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.0 ( 11.5 ) 50.7 ( 8.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 9 10 19
        Male
    		 0 0 0
    Race
    Units: Subjects
        White
    		 9 10 19
    Age
    Units: years
        median (full range (min-max))
    		 49.0 (36 to 71) 49.5 (38 to 67) -
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes all patients eligible to be dosed

    Subject analysis sets values
    		 FAS
    Number of subjects
    19
    Age Categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    17
        From 65-84 years
    2
        85 years and over
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    50.4 ( 9.6 )
    Gender Categorical
    Units: Subjects
        Female
    19
        Male
    0
    Race
    Units: Subjects
        White
    19
    Age
    Units: years
        median (full range (min-max))
    49.0 (36 to 71)

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 -

    Reporting group title
    Cohort 2
    Reporting group description
    		 Both arms have the same allocated treatment, however Cohort 2 allowed the use of a granulocyte colony stimulating factor (G-CSF; filgrastim) for initial management of neutropenia

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes all patients eligible to be dosed

    Primary: Patients with At Least One Adverse Event

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    End point title
    		 Patients with At Least One Adverse Event [1]
    End point description
    End point type
    Primary
    End point timeframe
    From signing of ICF throughout treatment period up to and including 30-day follow-up period.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
        Number of Patients
    9
    10
        Percentage
    100
    100
    No statistical analyses for this end point

    Primary: Patients with At Least One Adverse Event Causally Related to Olaparib

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    End point title
    		 Patients with At Least One Adverse Event Causally Related to Olaparib [2]
    End point description
    End point type
    Primary
    End point timeframe
    From signing of ICF throughout treatment period up to and including 30-day follow-up period.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
        Number of Patients
    7
    9
    No statistical analyses for this end point

    Primary: Patients with At Least One Adverse Event Causally Related to Paclitaxel

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    End point title
    		 Patients with At Least One Adverse Event Causally Related to Paclitaxel [3]
    End point description
    End point type
    Primary
    End point timeframe
    From signing of ICF throughout treatment period up to and including 30-day follow-up period.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
    9
    10
    No statistical analyses for this end point

    Primary: Patients with At Least One Adverse Event of CTCAE Grade 3 or Higher

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    End point title
    		 Patients with At Least One Adverse Event of CTCAE Grade 3 or Higher [4]
    End point description
    End point type
    Primary
    End point timeframe
    From signing of ICF throughout treatment period up to and including 30-day follow-up period.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
    8
    5
    No statistical analyses for this end point

    Primary: Patients with At Least One Adverse Event with Outcome Death

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    End point title
    		 Patients with At Least One Adverse Event with Outcome Death [5]
    End point description
    End point type
    Primary
    End point timeframe
    From signing of ICF throughout treatment period up to and including 30-day follow-up period.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Primary: Patients with At Least One Serious Adverse Event

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    End point title
    		 Patients with At Least One Serious Adverse Event [6]
    End point description
    End point type
    Primary
    End point timeframe
    From signing of ICF throughout treatment period up to and including 30-day follow-up period.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
    2
    4
    No statistical analyses for this end point

    Primary: Patients with At Least One Adverse Event Leading to Discontinuation of IP

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    End point title
    		 Patients with At Least One Adverse Event Leading to Discontinuation of IP [7]
    End point description
    End point type
    Primary
    End point timeframe
    From signing of ICF throughout treatment period up to and including 30-day follow-up period.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Primary: Number of patients with ≥2 CTC grade changes from baseline for haematology parameters

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    End point title
    		 Number of patients with ≥2 CTC grade changes from baseline for haematology parameters [8]
    End point description
    Baseline is defined as the last result obtained prior to the start of study treatment.
    End point type
    Primary
    End point timeframe
    Derived from lab assessments between the start of treatment and 30 days following the date of last dose of study medication.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
        Leucocytes
    9
    6
        Neutrophils
    7
    6
        Lymphocytes
    4
    4
        Platelets
    1
    1
        aPTT
    2
    1
    No statistical analyses for this end point

    Primary: Number of patients with CTC grade changes to 3 or 4 from baseline for haematology parameters

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    End point title
    		 Number of patients with CTC grade changes to 3 or 4 from baseline for haematology parameters [9]
    End point description
    End point type
    Primary
    End point timeframe
    Derived from lab assessments between the start of treatment and 30 days following the date of last dose of study medication. Baseline is defined as the last result obtained prior to the start of study treatment.
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
        Leucocytes
    3
    3
        Neutrophils
    2
    3
        Lymphocytes
    4
    3
        Platelets
    1
    0
        aPTT
    1
    0
    No statistical analyses for this end point

    Primary: Number of patients with ≥2 CTC grade changes from baseline for clinical chemistry parameters

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    End point title
    		 Number of patients with ≥2 CTC grade changes from baseline for clinical chemistry parameters [10]
    End point description
    End point type
    Primary
    End point timeframe
    Derived from lab assessments between the start of treatment and 30 days following the date of last dose of study medication. Baseline is defined as the last result obtained prior to the start of study treatment.
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    10
    Units: Subjects
        ALT
    0
    1
        AST
    0
    0
        γ-GT
    3
    1
        Total bilirubin
    0
    1
        ALP
    0
    0
        Albumin
    0
    1
        Amylase
    0
    0
        Lipase
    0
    3
        Creatinine
    1
    0
        Glucose (low)
    0
    0
        Glucose (high)
    4
    1
        Calcium (low)
    0
    0
        Calcium (high)
    0
    0
        Magnesium (low)
    0
    0
        Magnesium (high)
    0
    0
        Potassium (low)
    0
    0
        Potassium (high)
    2
    0
        Sodium (low)
    2
    2
        Sodium (high)
    0
    1
    No statistical analyses for this end point

    Primary: Number of patients with CTC grade changes to 3 or 4 from baseline for clinical chemistry parameters

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    End point title
    		 Number of patients with CTC grade changes to 3 or 4 from baseline for clinical chemistry parameters [11]
    End point description
    End point type
    Primary
    End point timeframe
    Derived from lab assessments between the start of treatment and 30 days following the date of last dose of study medication. Baseline is defined as the last result obtained prior to the start of study treatment.
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was terminated prematurely and therefore there was no formal statistical analysis of safety and tolerability data
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9 [12]
    10 [13]
    Units: Subjects
        ALT
    0
    2
        AST
    0
    2
        γ-GT
    1
    3
        Total bilirubin
    0
    1
        ALP
    0
    1
        Albumin
    0
    0
        Amylase
    0
    1
        Lipase
    0
    1
        Creatinine
    0
    0
        Glucose (low)
    0
    0
        Glucose (high)
    3
    1
        Calcium (low)
    0
    0
        Calcium (high)
    0
    0
        Magnesium (low)
    0
    0
        Magnesium (high)
    0
    0
        Potassium (low)
    0
    0
        Potassium (high)
    1
    0
        Sodium (low)
    2
    2
        Sodium (high)
    0
    1
    Notes
    [12] - 1 patient had a Grade 4 CTC elevation in γ-GT at baseline with no change to max severity is excluded
    [13] - 1 patient had a Grade 4 CTC elevation in γ-GT at baseline with no change to max severity is excluded
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    200mg bd - Cohort 2
    Reporting group description
    		 -

    Reporting group title
    200mg bd - Cohort 1
    Reporting group description
    		 -

    Serious adverse events
    		 200mg bd - Cohort 2 200mg bd - Cohort 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 10 (40.00%)
    2 / 9 (22.22%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMODYNAMIC INSTABILITY
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    APHASIA
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (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
    CELLULITIS
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 200mg bd - Cohort 2 200mg bd - Cohort 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    9 / 9 (100.00%)
    Vascular disorders
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    HOT FLUSH
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    HYPERTENSION
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    HYPOTENSION
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    LYMPHOEDEMA
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    THROMBOPHLEBITIS SUPERFICIAL
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    CHILLS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    FATIGUE
         subjects affected / exposed
    4 / 10 (40.00%)
    7 / 9 (77.78%)
         occurrences all number
    4
    9
    FEELING COLD
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    MALAISE
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    OEDEMA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    OEDEMA PERIPHERAL
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    PYREXIA
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    THROMBOSIS IN DEVICE
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    BREAST PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    VULVOVAGINAL DISCOMFORT
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 9 (33.33%)
         occurrences all number
    0
    3
    DYSPHONIA
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    DYSPNOEA
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 9 (33.33%)
         occurrences all number
    3
    4
    EPISTAXIS
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 9 (22.22%)
         occurrences all number
    4
    2
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 9 (22.22%)
         occurrences all number
    3
    2
    PLEURAL EFFUSION
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    PRODUCTIVE COUGH
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    RHINORRHOEA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 9 (33.33%)
         occurrences all number
    1
    3
    CONFUSIONAL STATE
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    DEPRESSION
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    INSOMNIA
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    MOOD ALTERED
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    BLOOD LACTATE DEHYDROGENASE ABNORMAL
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    GAMMA-GLUTAMYLTRANSFERASE ABNORMAL
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    WEIGHT INCREASED
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    TACHYCARDIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Nervous system disorders
    APHONIA
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    ATAXIA
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    COGNITIVE DISORDER
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    DIZZINESS
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 9 (33.33%)
         occurrences all number
    0
    3
    DYSGEUSIA
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 9 (22.22%)
         occurrences all number
    3
    2
    HEADACHE
         subjects affected / exposed
    2 / 10 (20.00%)
    3 / 9 (33.33%)
         occurrences all number
    2
    4
    HYPOAESTHESIA
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    LETHARGY
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 9 (22.22%)
         occurrences all number
    3
    2
    MIGRAINE
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 9 (33.33%)
         occurrences all number
    3
    3
    PARAESTHESIA
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 9 (33.33%)
         occurrences all number
    0
    3
    PERIPHERAL SENSORY NEUROPATHY
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    2
    SENSORY LOSS
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    SYNCOPE
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    TREMOR
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 10 (10.00%)
    5 / 9 (55.56%)
         occurrences all number
    1
    11
    LEUKOPENIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    4
    LYMPH NODE PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    NEUTROPENIA
         subjects affected / exposed
    4 / 10 (40.00%)
    7 / 9 (77.78%)
         occurrences all number
    9
    22
    Ear and labyrinth disorders
    TINNITUS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    VERTIGO
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Eye disorders
    DARK CIRCLES UNDER EYES
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    DRY EYE
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    EYE PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    EYE SWELLING
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    LACRIMATION INCREASED
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    VISION BLURRED
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 9 (33.33%)
         occurrences all number
    1
    3
    ABDOMINAL DISTENSION
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 10 (10.00%)
    4 / 9 (44.44%)
         occurrences all number
    1
    5
    ABDOMINAL WALL HAEMATOMA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    CONSTIPATION
         subjects affected / exposed
    2 / 10 (20.00%)
    4 / 9 (44.44%)
         occurrences all number
    2
    5
    DENTAL CARIES
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    DIARRHOEA
         subjects affected / exposed
    6 / 10 (60.00%)
    6 / 9 (66.67%)
         occurrences all number
    6
    7
    DRY MOUTH
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    DYSPEPSIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    GASTRITIS
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    1
    HAEMORRHOIDS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    MOUTH ULCERATION
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    NAUSEA
         subjects affected / exposed
    6 / 10 (60.00%)
    6 / 9 (66.67%)
         occurrences all number
    7
    11
    STOMATITIS
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    4
    VOMITING
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 9 (33.33%)
         occurrences all number
    4
    5
    Hepatobiliary disorders
    HEPATIC PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    ALOPECIA
         subjects affected / exposed
    4 / 10 (40.00%)
    7 / 9 (77.78%)
         occurrences all number
    4
    9
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    ERYTHEMA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    HYPERHIDROSIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    NAIL DISORDER
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    NIGHT SWEATS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    PRURITUS
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    2
    RASH
         subjects affected / exposed
    5 / 10 (50.00%)
    1 / 9 (11.11%)
         occurrences all number
    8
    1
    SKIN DISORDER
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    ANURIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    DYSURIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    HAEMATURIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    POLLAKIURIA
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    RENAL FAILURE
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    STRESS URINARY INCONTINENCE
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    URINARY RETENTION
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    4
    ARTHRITIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    BACK PAIN
         subjects affected / exposed
    4 / 10 (40.00%)
    2 / 9 (22.22%)
         occurrences all number
    4
    2
    BONE PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    MUSCLE SPASMS
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    MUSCLE TIGHTNESS
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    MUSCULAR WEAKNESS
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    3
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    MUSCULOSKELETAL STIFFNESS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    MYALGIA
         subjects affected / exposed
    2 / 10 (20.00%)
    4 / 9 (44.44%)
         occurrences all number
    2
    4
    NECK PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    Infections and infestations
    CYSTITIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    DEVICE RELATED INFECTION
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    HERPES ZOSTER
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    3
    SINUSITIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    SKIN INFECTION
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 9 (22.22%)
         occurrences all number
    5
    4
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    VIRAL PHARYNGITIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    ACIDOSIS
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    DECREASED APPETITE
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    3
    DEHYDRATION
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2009
    Addresses dose modifications, introducing in a step-wise approach the addition of granulocyte-colony stimulating factor (G-CSF) support (Cohort 2)
    17 Mar 2009
    Changes to Phase II part of the trial: Giving patients the possibility to receive maximum tolerated dose of Olaparib on monotherapy, removing requirement for BRCA testing and incorporating a single interim analysis of progression free survival
    04 Aug 2009
    Addresses the study closure, the management of Phase I patients currently receiving study treatment, and the definition of end of study given the decision not to proceed to Phase II.

    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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