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    Clinical Trial Results:
    A Phase II, Open label, Non randomised, Non comparative, Multicentre study to assess the efficacy and safety of olaparib given orally twice daily in patients with advanced cancers who have a confirmed genetic BRCA 1 and/or BRCA2 mutation

    Summary
    EudraCT number
    		 2010-022278-15
    Trial protocol
    		 DE   SE   ES  
    Global end of trial date
    12 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Aug 2025
    First version publication date
    28 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D0810C00042
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01078662
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85, Sodertalje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@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
    31 Jul 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. 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 Conference on Harmonization/Good Clinical Practice (GCP), applicable regulatory requirements, and the AstraZeneca policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Feb 2010
    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
    Australia: 39
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    Israel: 136
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United States: 63
    Worldwide total number of subjects
    298
    EEA total number of subjects
    60
    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)
    250
    From 65 to 84 years
    48
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 13 sites across Israel, Germany, Spain, Australia, USA, Sweden. Enrolment started in Feb 2010 and was completed in Jul 2012. In total, 298 patients had received treatment (olaparib).

    Pre-assignment
    Screening details
    		 Patients >17 years age with histologically and/or cytologically confirmed malignant solid tumours, refractory to standard therapy for which no suitable effective/curative therapy. Patients with confirmed deleterious or suspected deleterious BRCA mutation, Eastern Co-operative Oncology Group performance status ≤2 and life expectancy of ≥12 weeks.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Breast Cancer
    Arm description
    		 Patients with primary cancer site = breast. Receiving olaparib 400mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    AZD2281
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib was dispensed to patients on Day 1 and every 28 days thereafter until the patient completed the study, patient was withdrawn from the study, or the study was closed. Patients were to take Olaparib 400 mg (50 mg ×8 capsules) bd orally at the same time each day, approximately 12 hours apart, morning and evening, with a glass of water. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption. The Olaparib capsules were to be swallowed whole. The capsules were not to be chewed, crushed, dissolved, or divided. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption.

    Arm title
    		 Ovarian Cancer
    Arm description
    		 Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    AZD2281
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib was dispensed to patients on Day 1 and every 28 days thereafter until the patient completed the study, patient was withdrawn from the study, or the study was closed. Patients were to take Olaparib 400 mg (50 mg ×8 capsules) bd orally at the same time each day, approximately 12 hours apart, morning and evening, with a glass of water. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption. The Olaparib capsules were to be swallowed whole. The capsules were not to be chewed, crushed, dissolved, or divided. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption.

    Arm title
    		 Pancreatic Cancer
    Arm description
    		 Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    AZD2281
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib was dispensed to patients on Day 1 and every 28 days thereafter until the patient completed the study, patient was withdrawn from the study, or the study was closed. Patients were to take Olaparib 400 mg (50 mg ×8 capsules) bd orally at the same time each day, approximately 12 hours apart, morning and evening, with a glass of water. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption. The Olaparib capsules were to be swallowed whole. The capsules were not to be chewed, crushed, dissolved, or divided. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption.

    Arm title
    		 Prostate Cancer
    Arm description
    		 Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    AZD2281
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib was dispensed to patients on Day 1 and every 28 days thereafter until the patient completed the study, patient was withdrawn from the study, or the study was closed. Patients were to take Olaparib 400 mg (50 mg ×8 capsules) bd orally at the same time each day, approximately 12 hours apart, morning and evening, with a glass of water. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption. The Olaparib capsules were to be swallowed whole. The capsules were not to be chewed, crushed, dissolved, or divided. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption.

    Arm title
    		 Other Cancers
    Arm description
    		 Patients with other primary cancers. Receiving olaparib 400mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    AZD2281
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib was dispensed to patients on Day 1 and every 28 days thereafter until the patient completed the study, patient was withdrawn from the study, or the study was closed. Patients were to take Olaparib 400 mg (50 mg ×8 capsules) bd orally at the same time each day, approximately 12 hours apart, morning and evening, with a glass of water. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption. The Olaparib capsules were to be swallowed whole. The capsules were not to be chewed, crushed, dissolved, or divided. Patients were instructed to take their doses of Olaparib at least 1 hour after food and had to refrain from eating for next 2 hours due to potential effect of food on absorption.

    Number of subjects in period 1
    		Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers
    Started
    62
    193
    23
    8
    12
    Completed
    4
    25
    2
    1
    1
    Not completed
    58
    168
    21
    7
    11
         Consent withdrawn by subject
    4
    11
    1
    -
    -
         Patients reached data cut-off
    12
    53
    2
    2
    3
         Death (patients in survival followup included)
    41
    103
    18
    5
    8
         Lost to follow-up
    1
    -
    -
    -
    -
         Protocol deviation
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Breast Cancer
    Reporting group description
    		 Patients with primary cancer site = breast. Receiving olaparib 400mg BID

    Reporting group title
    Ovarian Cancer
    Reporting group description
    		 Patients with primary cancer site = ovary. Receiving olaparib 400mg BID

    Reporting group title
    Pancreatic Cancer
    Reporting group description
    		 Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID

    Reporting group title
    Prostate Cancer
    Reporting group description
    		 Patients with primary cancer site = prostate. Receiving olaparib 400mg BID

    Reporting group title
    Other Cancers
    Reporting group description
    		 Patients with other primary cancers. Receiving olaparib 400mg BID

    Reporting group values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers Total
    Number of subjects
    		 62 193 23 8 12 298
    Age Categorical
    Age by category
    Units:
        < 50 years
    		 33 40 6 0 4 83
        >=50 to <65 years
    		 28 117 14 3 5 167
        >= 65 years
    		 1 36 3 5 3 48
    Age Continuous
    Age at time of screening
    Units: years
        arithmetic mean (standard deviation)
    		 47.6 ( 9.69 ) 57.2 ( 9.28 ) 57.1 ( 7.99 ) 66.6 ( 9.86 ) 54.9 ( 12.38 ) -
    Sex: Female, Male
    Gender
    Units:
        Female
    		 61 193 10 0 8 272
        Male
    		 1 0 13 8 4 26
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        White
    		 60 183 21 8 11 283
        Black or African American
    		 0 1 1 0 0 2
        Asian
    		 1 8 1 0 1 11
        Other
    		 1 1 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    Breast Cancer
    Reporting group description
    		 Patients with primary cancer site = breast. Receiving olaparib 400mg BID

    Reporting group title
    Ovarian Cancer
    Reporting group description
    		 Patients with primary cancer site = ovary. Receiving olaparib 400mg BID

    Reporting group title
    Pancreatic Cancer
    Reporting group description
    		 Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID

    Reporting group title
    Prostate Cancer
    Reporting group description
    		 Patients with primary cancer site = prostate. Receiving olaparib 400mg BID

    Reporting group title
    Other Cancers
    Reporting group description
    		 Patients with other primary cancers. Receiving olaparib 400mg BID

    Primary: Tumour response rate

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    End point title
    		 Tumour response rate [1]
    End point description
    Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Full analysis set - all treated patients.
    End point type
    Primary
    End point timeframe
    Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
    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: Summary of analysis of tumour response rate has been included here
    End point values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers
    Number of subjects analysed
    62
    193
    23
    8
    12
    Units: Percentage of participants
        number (confidence interval 95%)
    12.9 (5.74 to 23.85)
    31.1 (24.64 to 38.13)
    21.7 (7.46 to 43.7)
    50 (15.7 to 84.3)
    8.3 (0.21 to 38.48)
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline.
    End point type
    Secondary
    End point timeframe
    Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
    End point values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers
    Number of subjects analysed
    58
    167
    23
    7
    11
    Units: Percentage of participants
        number (confidence interval 95%)
    13.8 (6.15 to 25.38)
    35.9 (28.66 to 43.7)
    21.7 (7.46 to 43.7)
    57.1 (18.41 to 90.1)
    9.1 (0.23 to 41.28)
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    		 Progression free survival [2]
    End point description
    Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit. Full analysis set - all treated patients. The "Other" cancer group was not analysed in accordance with the protocol.
    End point type
    Secondary
    End point timeframe
    Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per the CSR table results, there are 4 arms summarised for median PFS which are all included here
    End point values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer
    Number of subjects analysed
    62
    193
    23
    8
    Units: months
        median (inter-quartile range (Q1-Q3))
    3.68 (1.76 to 7.52)
    7.03 (3.65 to 11.24)
    4.55 (1.81 to 8.21)
    7.15 (2.63 to 17.45)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival [3]
    End point description
    Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive. Full analysis set - all treated patients. The "Other" cancer group was not analysed in accordance with the protocol.
    End point type
    Secondary
    End point timeframe
    Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per the CSR table results, there are 4 arms summarised for median OS which are all included here
    End point values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer
    Number of subjects analysed
    62
    193
    23
    8
    Units: months
        median (inter-quartile range (Q1-Q3))
    11.01 (5.68 to 24.18)
    16.62 (9.43 to 99999)
    9.81 (3.84 to 16.62)
    18.38 (6.24 to 25.46)
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression. Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.
    End point type
    Secondary
    End point timeframe
    From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months
    End point values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers
    Number of subjects analysed
    8
    60
    5
    4
    1
    Units: days
        median (inter-quartile range (Q1-Q3))
    204 (149.5 to 405)
    225 (143 to 410)
    134 (131 to 141)
    326.5 (164 to 476)
    165 (165 to 165)
    No statistical analyses for this end point

    Secondary: Overall survival rate at 12 months

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    End point title
    		 Overall survival rate at 12 months [4]
    End point description
    Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose. Full analysis set - all treated patients. The "Other" cancer group was not analysed in accordance with the protocol.
    End point type
    Secondary
    End point timeframe
    Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per the CSR table results, there are 4 arms summarised for OS survival rate at 12 months which are all included here
    End point values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer
    Number of subjects analysed
    62
    193
    23
    8
    Units: Percentage of participants
        number (not applicable)
    44.7
    64.4
    40.9
    50
    No statistical analyses for this end point

    Secondary: Disease control rate at week 16

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    End point title
    		 Disease control rate at week 16
    End point description
    Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16. Full analysis set - all treated patients.
    End point type
    Secondary
    End point timeframe
    Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16
    End point values
    		 Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers
    Number of subjects analysed
    62
    193
    23
    8
    12
    Units: Percentage of participants
        number (confidence interval 95%)
    37.1 (25.16 to 50.31)
    58 (50.73 to 65.08)
    47.8 (26.82 to 69.41)
    62.5 (24.49 to 91.48)
    33.3 (9.92 to 65.11)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    If any SAE occurs in the course of the study, then within one day ie, immediately but no later than the end of the next business day of when he or she becomes aware of it.
    Adverse event reporting additional description
    The designated AstraZeneca representative works with the investigator to ensure that all the necessary information is provided to the AstraZeneca Patient Safety data entry site within one calendar day of initial receipt for fatal and life threatening events and within five calendar days of initial receipt for all other SAEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    OLAPARIB
    Reporting group description
    		 -

    Serious adverse events
    		 OLAPARIB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    90 / 298 (30.20%)
         number of deaths (all causes)
    175
         number of deaths resulting from adverse events
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    GASTRIC CANCER
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ACUTE MYELOID LEUKAEMIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    ACUTE LEUKAEMIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    DEVICE OCCLUSION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FATIGUE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PYREXIA
         subjects affected / exposed
    3 / 298 (1.01%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    PULMONARY EMBOLISM
         subjects affected / exposed
    4 / 298 (1.34%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    PLEURAL EFFUSION
         subjects affected / exposed
    4 / 298 (1.34%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    4 / 298 (1.34%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    SUICIDE ATTEMPT
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ANXIETY
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    WOUND DEHISCENCE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    TOXICITY TO VARIOUS AGENTS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    PERICARDIAL EFFUSION
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SYNCOPE
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    13 / 298 (4.36%)
         occurrences causally related to treatment / all
    12 / 14
         deaths causally related to treatment / all
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    3 / 298 (1.01%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    LEUKOPENIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    3 / 298 (1.01%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    RETINAL DETACHMENT
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DIPLOPIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    OBSTRUCTION GASTRIC
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LARGE INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTESTINAL MASS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ENTERITIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    7 / 298 (2.35%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    ABDOMINAL HERNIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABDOMINAL PAIN
         subjects affected / exposed
    11 / 298 (3.69%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    ASCITES
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CONSTIPATION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    3 / 298 (1.01%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    GASTROINTESTINAL OBSTRUCTION
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    GASTROINTESTINAL PERFORATION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NAUSEA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VOMITING
         subjects affected / exposed
    5 / 298 (1.68%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    7 / 298 (2.35%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    OESOPHAGEAL STENOSIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ILEUS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    CHOLANGITIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    URINARY RETENTION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL FAILURE ACUTE
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    OSTEONECROSIS OF JAW
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MUSCULAR WEAKNESS
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    HAEMARTHROSIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GROIN PAIN
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    GASTROENTERITIS
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    DEVICE RELATED SEPSIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    STAPHYLOCOCCAL SEPSIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABDOMINAL ABSCESS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ENTEROBACTER SEPSIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    INFECTION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    4 / 298 (1.34%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    SEPSIS
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    HYPONATRAEMIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPERKALAEMIA
         subjects affected / exposed
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 OLAPARIB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    290 / 298 (97.32%)
    Investigations
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    21 / 298 (7.05%)
         occurrences all number
    21
    WEIGHT DECREASED
         subjects affected / exposed
    26 / 298 (8.72%)
         occurrences all number
    26
    Vascular disorders
    HOT FLUSH
         subjects affected / exposed
    19 / 298 (6.38%)
         occurrences all number
    20
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    48 / 298 (16.11%)
         occurrences all number
    60
    DYSGEUSIA
         subjects affected / exposed
    47 / 298 (15.77%)
         occurrences all number
    47
    DIZZINESS
         subjects affected / exposed
    34 / 298 (11.41%)
         occurrences all number
    34
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    25 / 298 (8.39%)
         occurrences all number
    33
    PYREXIA
         subjects affected / exposed
    37 / 298 (12.42%)
         occurrences all number
    51
    OEDEMA PERIPHERAL
         subjects affected / exposed
    41 / 298 (13.76%)
         occurrences all number
    48
    FATIGUE
         subjects affected / exposed
    176 / 298 (59.06%)
         occurrences all number
    199
    Blood and lymphatic system disorders
    THROMBOCYTOPENIA
         subjects affected / exposed
    28 / 298 (9.40%)
         occurrences all number
    36
    LEUKOPENIA
         subjects affected / exposed
    23 / 298 (7.72%)
         occurrences all number
    35
    ANAEMIA
         subjects affected / exposed
    90 / 298 (30.20%)
         occurrences all number
    120
    Gastrointestinal disorders
    DYSPEPSIA
         subjects affected / exposed
    52 / 298 (17.45%)
         occurrences all number
    54
    DRY MOUTH
         subjects affected / exposed
    19 / 298 (6.38%)
         occurrences all number
    20
    DIARRHOEA
         subjects affected / exposed
    81 / 298 (27.18%)
         occurrences all number
    103
    ABDOMINAL DISTENSION
         subjects affected / exposed
    33 / 298 (11.07%)
         occurrences all number
    35
    ABDOMINAL PAIN
         subjects affected / exposed
    66 / 298 (22.15%)
         occurrences all number
    85
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    25 / 298 (8.39%)
         occurrences all number
    27
    CONSTIPATION
         subjects affected / exposed
    42 / 298 (14.09%)
         occurrences all number
    53
    VOMITING
         subjects affected / exposed
    109 / 298 (36.58%)
         occurrences all number
    158
    NAUSEA
         subjects affected / exposed
    176 / 298 (59.06%)
         occurrences all number
    218
    FLATULENCE
         subjects affected / exposed
    23 / 298 (7.72%)
         occurrences all number
    28
    Respiratory, thoracic and mediastinal disorders
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    16 / 298 (5.37%)
         occurrences all number
    18
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    15 / 298 (5.03%)
         occurrences all number
    15
    DYSPNOEA
         subjects affected / exposed
    36 / 298 (12.08%)
         occurrences all number
    44
    COUGH
         subjects affected / exposed
    42 / 298 (14.09%)
         occurrences all number
    52
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    15 / 298 (5.03%)
         occurrences all number
    16
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    17 / 298 (5.70%)
         occurrences all number
    17
    INSOMNIA
         subjects affected / exposed
    22 / 298 (7.38%)
         occurrences all number
    22
    DEPRESSION
         subjects affected / exposed
    19 / 298 (6.38%)
         occurrences all number
    19
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    17 / 298 (5.70%)
         occurrences all number
    18
    PAIN IN EXTREMITY
         subjects affected / exposed
    25 / 298 (8.39%)
         occurrences all number
    26
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    15 / 298 (5.03%)
         occurrences all number
    16
    ARTHRALGIA
         subjects affected / exposed
    27 / 298 (9.06%)
         occurrences all number
    33
    BACK PAIN
         subjects affected / exposed
    37 / 298 (12.42%)
         occurrences all number
    43
    MUSCLE SPASMS
         subjects affected / exposed
    27 / 298 (9.06%)
         occurrences all number
    31
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    23 / 298 (7.72%)
         occurrences all number
    26
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    23 / 298 (7.72%)
         occurrences all number
    29
    URINARY TRACT INFECTION
         subjects affected / exposed
    30 / 298 (10.07%)
         occurrences all number
    44
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    62 / 298 (20.81%)
         occurrences all number
    67

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2010
    Section 4.1 Inclusion Criteria; criteria 3-8 changed. Section 4.2 Exclusion Criteria, criterion 3 changed. Section 5.6.2 Antiemetics/Antidiarrhoeals revised. Section 5.7 Treatment compliance, 2nd paragraph changed. Section 9.5 Study timetable and end of the study, 1st paragraph changed.
    26 Aug 2010
    Protocol Synopsis - Study centre(s) and number of patients planned changed. Protocol Synopsis – Objectives, exploratory objectives added. Protocol Synopsis – Study design, paragraph 2 changed. Protocol Synopsis –Target population revised. Protocol Synopsis - Outcome variable(s), Exploratory outcome variable added. Protocol Synopsis – Statistical Methods, paragraph 1 changed. Section of protocol 2.4 Exploratory objectives added. Section of protocol 3.1 Overall study design and flow chart, paragraph 3, Table 1 and Table 2 are changed. Section of protocol 4.1 Inclusion Criteria; criteria 4, 5, 7 and 8 changed. Section of protocol 4.2 Exclusion criteria added. Section of protocol 5.5.2 Doses and treatment regimens, first paragraph changed. Section of protocol 6.2.2.2 BRCA status – 2nd paragraph added. Section of protocol 6.2.3.4 CT or MRI scans (RECIST 1.1) – 3rd paragraph added. Section of protocol 7.1 Volume of blood revised. Section of protocol 7.2 Handling, storage and destruction of biological samples revised. Section of protocol 7.3 Labelling and shipment of biohazard samples revised. Section of protocol 7.4 Chain of custody of biological samples revised. Section of protocol 7.5 Withdrawal of informed consent for donated biological samples revised. Section of protocol 11.1.2 Secondary Endpoints – only part “Progression free survival (PFS)” changed. Section of protocol 12.3 Determination of sample size revised. Section of protocol 13.2 Overdose – 6th paragraph added.
    08 Aug 2011
    Protocol synopsis Study period, Study design, and Duration of treatment revised. Section of protocol 1.1.10 Clinical experience revised. Section of protocol 3.1 Overall study design and flow chart revised. Section of protocol 5.5.6 Management of toxicity of olaparib (monotherapy treatment) revised. Section of protocol 5.8 Discontinuation of investigational product revised. Section of protocol 5.8.1 Procedures for discontinuation of a patient from investigational product revised. Section of protocol 6.2.2 On-trial assessments revised. Section of protocol 6.2.2.2 BRCA status revised. New section in protocol is added: 6.2.2.3 Hormonal receptor status. Section of protocol 6.4.3 Recording of adverse events paragraph Adverse Events based on examinations and tests is changed. Section of protocol 6.4.5 Laboratory safety assessment revised. Section of protocol 6.4.8.1 Pulse and blood pressure revised. New protocol section added: 6.4.9.2 Bone marrow analysis or blood sample cytogenetics. Section of protocol 9.5 Study timetable and end of study revised. Section of protocol 12.2.2.5 Disease Control Rate (DCR) revised. Section of protocol 13.1 Medical emergencies and AstraZeneca contacts revised.
    09 Jul 2021
    Addition of language regarding transition from capsule form to tablet form for those patients in continued access phase, including labelling, follow up, overdose and recommended capsule doses to equivalent tablet doses due to discontinuation of capsule manufacture in the following sections: Synopsis, Sections 3.1 Overall study design and flow chart, 5.5.1 Identity of investigational product, 5.5.2 Doses and treatment, 5.5.4 Labelling, 9.5 Study timetable and end of study, 13.2 Overdose and NEW Sections 5.5.7 Dose modifications during the continued access phase and 6.2.3.5 Patients in the continued access phase. Updated language on contraception and length of time on contraception in accordance with update of Investigator’s Brochure in Section 5.1 Restrictions during the study, 13.3.1 Maternal exposure and Appendix D Acceptable birth control methods. Updated language on live/bacterial vaccines not being permitted while taking olaparib in accordance with standard olaparib text regarding vaccines in Sections 5.1 Restrictions during the study and 5.6.5 Medications that may NOT be administered. Updated safety language regarding adverse events of special interest in accordance with update of Investigator’s Brochure in Section 6.4.3 Recording of adverse events. Removal of contact names and details in title page and Section 13.1 Medical emergencies and AstraZeneca contacts due to contact details out of date and language no longer consistent with current protocol template.

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

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

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