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    Clinical Trial Results:
    A prospective, multi-centre, open label, non-randomised two stage phase II clinical trial evaluating the efficacy of abiraterone in patients with epithelial ovarian (including fallopian tube and primary peritoneal) cancer.

    Summary
    EudraCT number
    2013-000293-29
    Trial protocol
    GB  
    Global end of trial date
    28 Jan 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Feb 2022
    First version publication date
    06 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ICR-CTSU/2012/10038
    Additional study identifiers
    ISRCTN number
    ISRCTN63407050
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Sponsor Identification Number:: CCR3948, ICR-CTSU Protocol Number: ICR-CTSU/2021/10038, CRUK Reference Number:: A16037, Main REC Reference:: 13/LO/1599, MHRA CTA Reference Number:: 15983/0242/001-0001
    Sponsors
    Sponsor organisation name
    The Institute of Cancer Research
    Sponsor organisation address
    5 Cotswold Road, Sutton, United Kingdom, SM2 5NG
    Public contact
    Christy Toms, Clinical Trials Programme Manager, The Institute of Cancer Research, +44 0208 722 4266, coral-icrctsu@icr.ac.uk
    Scientific contact
    Christy Toms, Clinical Trials Programme Manager, The Institute of Cancer Research, +44 0208 722 4266, coral-icrctsu@icr.ac.uk
    Sponsor organisation name
    The Royal Marsden NHS Foundation Trust
    Sponsor organisation address
    Downs Road, Sutton, United Kingdom,
    Public contact
    Christy Toms, Clinical Trials Programme Manager, The Royal Marsden NHS Foundation Trust, +44 0208 722 4266, coral-icrctsu@icr.ac.uk
    Scientific contact
    Christy Toms, Clinical Trials Programme Manager, The Royal Marsden NHS Foundation Trust, +44 0208 722 4266, coral-icrctsu@icr.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine whether abiraterone has clinical activity (objective response rate assessed by imaging and/or CA125 tumour marker changes in the blood) in patients with epithelial ovarian cancer (EOC) that has relapsed within 12 months of last treatment. 26 patients 'unselected' for androgen receptor (AR) status will be treated in stage one and, if successful, a further 21 patients in stage two bringing the total number of patients required to 47.
    Protection of trial subjects
    Patients were provided with full verbal and written informed consent regarding the purpose and procedures of the trial and the possible risks involved. A patient information sheet and consent form were provided and patients were given sufficient time to consider their participation. The Principal Investigator at each site was responsible for ensuring written informed consent was obtained for each patient. Full details of the trial medication and its safety profile were provided in the patient information sheet. Patients had the opportunity to discuss any concerns they had in relation to this with their study team at site.
    Background therapy
    All patients received prednisone or prednisolone (at clinician's discretion) at 5mg orally once daily to prevent secondary mineralocorticoid excess.
    Evidence for comparator
    This was a two-stage phase II, non-randomised clinical trial with all patients receiving abiraterone once a day on a continuous 28-day cycle until disease progression.
    Actual start date of recruitment
    09 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    0
    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)
    20
    From 65 to 84 years
    21
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    Forty-two patients were recruited from four UK centres between21 March 2014 and 3 November 2015

    Pre-assignment
    Screening details
    Post-menopausal women with histologically or cytologically confirmed epithelial ovarian, fallopian tube (FT) or primary peritoneal (PP) cancer were eligible if they had progressed (radiological or CA125 criteria) within 12 months of last systemic anti-cancer therapy. 50 patients were registered, 42 proceeded to trial entry.

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

    Arms
    Arm title
    Abiraterone
    Arm description
    All patients receive an oral dose of abiraterone 100mg (4 x 250mg tablets) once a day on a continuous 28 day cycle
    Arm type
    Experimental

    Investigational medicinal product name
    abiraterone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral dose of 1000mg (4 x 250mg) once a day on a continuous 28 day cycle

    Number of subjects in period 1
    Abiraterone
    Started
    42
    Stage 1
    42
    Completed
    37
    Not completed
    5
         Adverse event, non-fatal
    2
         Consent withdrawn by subject
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    42 42
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    20 20
        From 65-84 years
    21 21
        85 years and over
    1 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    65.4 (55.7 to 72.7) -
    Gender categorical
    Units: Subjects
        Female
    42 42
    Histological subtype (central assessment)
    Units: Subjects
        High grade serous
    37 37
        Low grade serous
    3 3
        Endometrioid
    2 2
    AR status
    Units: Subjects
        AR positive (>10%)
    29 29
        AR negative (<10%)
    11 11
        Missing
    2 2

    End points

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    End points reporting groups
    Reporting group title
    Abiraterone
    Reporting group description
    All patients receive an oral dose of abiraterone 100mg (4 x 250mg tablets) once a day on a continuous 28 day cycle

    Subject analysis set title
    Stage 1
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Stage 1 includes the first 26 patients recruited to the CORAL trial regardless of evaluability of the patient.

    Subject analysis set title
    Evaluable
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Any patient who had a scan at 12 weeks and/or progressed/died prior to 12 weeks is considered evaluable and will be included in the analysis of the evaluable population. Any patient discontinuing the trial for other reasons prior to 12 weeks would not be considered evaluable.

    Primary: Objective response

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    End point title
    Objective response [1]
    End point description
    Primary endpoint is objective response rate at 12 weeks after registration. Objective response is defined as a complete or partial response according to joint RECIST/GCIG criteria.
    End point type
    Primary
    End point timeframe
    Up to 12 weeks from trial entry.
    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 is a single arm study and no comparative analysis was performed, however the system expects at least 2 groups to be identified. All methods and options specified in the analysis section apply to statistical methods and summary measures to report and compare at least 2 independent groups, which is not the case in this single arm trial. There is no way of reporting one group inference and summary values without triggering an error or reporting inaccurate information.
    End point values
    Abiraterone Stage 1 Evaluable
    Number of subjects analysed
    42
    26
    37
    Units: Patients
        Responder
    1
    1
    1
        Non-responder
    41
    25
    36
    No statistical analyses for this end point

    Secondary: Objective response according to RECIST

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    End point title
    Objective response according to RECIST
    End point description
    The proportion of patients with objective response according to RECIST v1.1.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks after trial entry.
    End point values
    Abiraterone Stage 1 Evaluable
    Number of subjects analysed
    42
    26
    34 [2]
    Units: Patients
        Responder
    0
    0
    0
        Non-responder
    39
    25
    34
        Not evaluable
    3
    1
    0
    Notes
    [2] - 3 patients were considered evaluable for CA125 but non evaluable for RECIST.
    No statistical analyses for this end point

    Secondary: Objective response according to GCIG (CA125)

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    End point title
    Objective response according to GCIG (CA125)
    End point description
    The proportion of patients with objective response according to CA125 criteria as recommended by the Gynaecologic Cancer InterGroup (GCIG) guidelines issued November 2005.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks post trial entry.
    End point values
    Abiraterone Stage 1 Evaluable
    Number of subjects analysed
    42
    26
    32 [3]
    Units: Patients
        Responder
    1
    1
    1
        Non-responder
    36
    22
    31
        Non-evaluable
    5
    3
    0
    Notes
    [3] - 5 patients were evaluable for RECIST but not CA125 so are excluded from this analysis
    No statistical analyses for this end point

    Secondary: Clinical benefit rate

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    End point title
    Clinical benefit rate
    End point description
    Clinical benefit rate according to RECIST/GCIG criteria at 12 weeks.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks post trial entry.
    End point values
    Abiraterone Stage 1 Evaluable
    Number of subjects analysed
    42
    26
    37
    Units: Patients
        Clinical benefit
    11
    7
    11
        No clinical benefit
    31
    19
    26
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    Progression free survival
    End point description
    Progression free survival will be measured from date of registration until date of confirmed progressive disease or death. Subjects who have not progressed or died at time of analysis will be censored at the date of last follow up.
    End point type
    Secondary
    End point timeframe
    From trial entry until patient progression.
    End point values
    Abiraterone
    Number of subjects analysed
    42
    Units: Months
        median (confidence interval 95%)
    2.5 (1.8 to 3.4)
    No statistical analyses for this end point

    Secondary: Time to progression

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    End point title
    Time to progression
    End point description
    Time to progression is measured from date of registration until date of confirmed progressive disease. Subjects who have died without prior confirmation of progression or are alive and have not progressed will be considered censored at date of death/latest follow up.
    End point type
    Secondary
    End point timeframe
    From trial entry until progression.
    End point values
    Abiraterone
    Number of subjects analysed
    42
    Units: Months
        median (confidence interval 95%)
    2.2 (1.8 to 2.7)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    Overall survival is measured from the date of registration until date of death of any cause.
    End point type
    Secondary
    End point timeframe
    From trial entry until death.
    End point values
    Abiraterone
    Number of subjects analysed
    42
    Units: Months
        median (confidence interval 95%)
    9.8 (7.3 to 17.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From trial entry until 28 days post treatment discontinuation.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Abiraterone
    Reporting group description
    All patients receive an oral dose of abiraterone 100mg (4 x 250mg tablets) once a day on a continuous 28 day cycle

    Serious adverse events
    Abiraterone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 42 (35.71%)
         number of deaths (all causes)
    40
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood creatine increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Migraine with aura
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Arthritis infective
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Abiraterone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 42 (95.24%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    8
    Hypertension
         subjects affected / exposed
    28 / 42 (66.67%)
         occurrences all number
    32
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    26 / 42 (61.90%)
         occurrences all number
    35
    Oedema peripheral
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    7
    Pain
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Hepatic enzyme increased
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    6
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    12 / 42 (28.57%)
         occurrences all number
    16
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    5
    Neuropathy peripheral
         subjects affected / exposed
    16 / 42 (38.10%)
         occurrences all number
    24
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    8
    Abdominal distension
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Abdominal pain
         subjects affected / exposed
    27 / 42 (64.29%)
         occurrences all number
    36
    Constipation
         subjects affected / exposed
    21 / 42 (50.00%)
         occurrences all number
    31
    Diarrhoea
         subjects affected / exposed
    11 / 42 (26.19%)
         occurrences all number
    17
    Dyspepsia
         subjects affected / exposed
    8 / 42 (19.05%)
         occurrences all number
    8
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    19 / 42 (45.24%)
         occurrences all number
    23
    Stomatitis
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    13 / 42 (30.95%)
         occurrences all number
    16
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    11 / 42 (26.19%)
         occurrences all number
    12
    Musculoskeletal pain
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    18 / 42 (42.86%)
         occurrences all number
    18
    Hypokalaemia
         subjects affected / exposed
    10 / 42 (23.81%)
         occurrences all number
    15
    Hypomagnesaemia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Hyponatraemia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    8
    Sinusitis
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Sep 2015
    1. Update to Investigator Brochure v11 (22/09/2015) and associated protocol/patient information sheet changes 2. Change of principal analysis population to 'Intention to Treat' from the 'evaluable' population 3. Update to exclusion criterion 'unresolved bowel obstruction' to include 'or symptoms of sub-acute bowel obstruction' 4. Addition of exclusion criterion 'Ascites on clinical examination or significant ascites present on baseline imaging' 5. Addition of radiological confirmation of response (CT scan/MRI) at 28 days following initial assessment of response 6. Addition of a liver function test at the mid-point in cycle 1 to monitor serum transaminase levels following the first 2 weeks of abiraterone treatment. 7. Change in timing of optional progression sample collection from 'within 7 days after last treatment' to 'after last dose of abiraterone and before commencement of any new systemic therapy' 8. Change of AR positivity cut-off from 1% to 10%
    07 Oct 2015
    1. Temporary halt to recruitment
    20 Feb 2017
    1. Update to Investigator Brochure v12 (August 2015)

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Nov 2015
    Recruitment to the CORAL trial was paused until the formal interim analysis following stage 1 of the trial was complete. This protocol-specified interim analysis indicated that in respect of the study's primary endpoint the pre-planned activity threshold for abiraterone had not been met and the trial was closed to recruitment.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/33854564
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