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    Clinical Trial Results:
    SarCaBon: A randomised phase II trial of Saracatinib versus placebo for cancer-induced bone pain

    Summary
    EudraCT number
    		 2013-002505-62
    Trial protocol
    		 GB  
    Global end of trial date
    24 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2019
    First version publication date
    02 Dec 2019
    Other versions
    Summary report(s)
    		 Published study

    Trial information

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    Trial identification
    Sponsor protocol code
    STH16404
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02085603
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    8 Beech Hill Road, Trust Headquarters, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.researchadministration@nhs.net
    Scientific contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.researchadministration@nhs.net
    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
    24 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Is Saracatinib effective at reducing bone pain in cancer patients that have painful bone metastases by comparing patient’s self-reported pain ratings (0 – 10 point scale) after 4 weeks on treatment with pain scores from patients who receive placebo.
    Protection of trial subjects
    Patients were verbally re-consented at every clinic visit to make sure they still wanted to remain within the trial. Experimental tests that were research-specific were chosen so that any discomfort produced was minimal. If pain control during the study deteriorated radiotherapy was offered.
    Background therapy
    		 Usual care
    Evidence for comparator
    		 None were used
    Actual start date of recruitment
    11 Mar 2014
    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: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    6
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Trial opened to recruitment: 11/3/14 Trial closed to recruitment: 31/7/17 Territories: United Kingdom (Sheffield and Leeds)

    Pre-assignment
    Screening details
    		 Cytologically or histologically confirmed solid tumours or multiple myeloma with painful bone metastases and poor control of bone pain in spite of pain medication.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Pharmacokinetic measurement of study drug concentrations were not performed until the study had closed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active drug
    Arm description
    		 Patients in the active drug arm received the study medication
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saracatinib
    Investigational medicinal product code
    AZD0530
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    125mg tablet Once per day for 4 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matched placebo tablet Once per day for 4 weeks

    Number of subjects in period 1
    		Active drug Placebo
    Started
    7
    6
    Completed
    6
    6
    Not completed
    1
    0
         participant had SAE prior to commencing any treatm
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active drug
    Reporting group description
    		 Patients in the active drug arm received the study medication

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo arm

    Reporting group values
    		 Active drug Placebo Total
    Number of subjects
    		 7 6 13
    Age categorical
    Patients aged 16yrs or older Baseline average pain ≥ 2 and ≤ 9 on a 0-10 numerical scale recorded on at least two separate days using the Brief Pain Inventory-Short Form WHO performance status ≤ 2 Ability to take and absorb oral medications Able to give written informed consent and willing to follow the study protocol Adequate baseline haematological, hepatic and renal function
    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)
    		 4 2 6
        From 65-84 years
    		 3 4 7
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 61 (50 to 74) 65 (62 to 71) -
    Gender categorical
    Patients were recruited at random
    Units: Subjects
        Female
    		 3 2 5
        Male
    		 4 4 8
    Tumour type
    Histology of the primary cancer
    Units: Subjects
        Adenocarcinoma of prostate
    		 3 3 6
        Chordoma
    		 1 0 1
        Lung cancer
    		 0 2 2
        Adenocarcinoma of breast
    		 3 1 4

    End points

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    End points reporting groups
    Reporting group title
    Active drug
    Reporting group description
    		 Patients in the active drug arm received the study medication

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo arm

    Primary: Worst pain in last 24h after 4 weeks on treatment

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    End point title
    		 Worst pain in last 24h after 4 weeks on treatment [1]
    End point description
    Worst pain in last 24h, Brief Pain Inventory-Short form Q3
    End point type
    Primary
    End point timeframe
    After 4 weeks on treatment
    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: There is no statistical analysis provided for this endpoint as the trial did not reach the recruitment target and therefore performing formal statistics is not justified; the calculations lack sufficient power.
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-10
        arithmetic mean (standard deviation)
    6.0 ± 2.4
    6.6 ± 2.3
    No statistical analyses for this end point

    Primary: Least pain in last 24h after 4 weeks on treatment

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    End point title
    		 Least pain in last 24h after 4 weeks on treatment [2]
    End point description
    Least pain in last 24h Brief Pain Inventory-Short form Q4
    End point type
    Primary
    End point timeframe
    After 4 weeks on treatment
    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: There is no statistical analysis provided for this endpoint as the trial did not reach the recruitment target and therefore performing formal statistics is not justified; the calculations lack sufficient power.
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-10
        arithmetic mean (standard deviation)
    3.2 ± 2.0
    3.0 ± 3.1
    No statistical analyses for this end point

    Primary: Average pain in last 24h after 4 weeks on treatment

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    End point title
    		 Average pain in last 24h after 4 weeks on treatment [3]
    End point description
    Average pain in last 24h Brief Pain Inventory-Short form Q5
    End point type
    Primary
    End point timeframe
    After 4 weeks on treatment
    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: There is no statistical analysis provided for this endpoint as the trial did not reach the recruitment target and therefore performing formal statistics is not justified; the calculations lack sufficient power.
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-10
        arithmetic mean (standard deviation)
    4.3 ± 1.9
    4.7 ± 2.6
    No statistical analyses for this end point

    Primary: Pain right now after 4 weeks on treatment

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    End point title
    		 Pain right now after 4 weeks on treatment [4]
    End point description
    Pain right now Brief Pain Inventory-Short form Q6
    End point type
    Primary
    End point timeframe
    After 4 weeks on treatment
    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: There is no statistical analysis provided for this endpoint as the trial did not reach the recruitment target and therefore performing formal statistics is not justified; the calculations lack sufficient power.
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-10
        arithmetic mean (standard deviation)
    4.5 ± 2.7
    4.9 ± 2.6
    No statistical analyses for this end point

    Secondary: OME at end of 4 weeks treatment

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    End point title
    		 OME at end of 4 weeks treatment
    End point description
    Secondary objective: To determine if analgesic drug use deacreased when participants took saracatinib. This is measured by analgesic usage data for previous 24hours prior to baseline and each clinic visit. The dose of all opioids is coverted in to Oral Morphine Equivalent (OME).
    End point type
    Secondary
    End point timeframe
    After 4 weeks on treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units:  μg/day
        arithmetic mean (standard deviation)
    207 ± 327
    138 ± 167
    No statistical analyses for this end point

    Secondary: QLQ-BM22 painful site score after 4 weeks of treatment

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    End point title
    		 QLQ-BM22 painful site score after 4 weeks of treatment
    End point description
    Secondary objective: To determine if pain thresholds at symptomatic sites increased after treatment with saracatinib. This was measured using the QLQ-BM22 painful site scores.
    End point type
    Secondary
    End point timeframe
    After 4 weeks on treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-100
        arithmetic mean (standard deviation)
    36.0 ± 18.6
    28.3 ± 12.6
    No statistical analyses for this end point

    Secondary: QLQ-C30 global health related quality of life score after 4 weeks treatment

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    End point title
    		 QLQ-C30 global health related quality of life score after 4 weeks treatment
    End point description
    Secondary objective: To determine if pain-related symptoms and quality of life are improved by saracatinib . This is measured using the QLQ-C30 global health related quality of life score after 4 weeks treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks of treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-100
        arithmetic mean (standard deviation)
    66.6 ± 10.0
    69.1 ± 9.9
    No statistical analyses for this end point

    Secondary: QLQ-C30 pain score after 4 weeks treatment

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    End point title
    		 QLQ-C30 pain score after 4 weeks treatment
    End point description
    Secondary objective: To determine if pain-related symptoms and quality of life are improved by saracatinib . This is measured using the QLQ-C30 pain score after 4 weeks treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks on treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-100
        arithmetic mean (standard deviation)
    58.3 ± 17.5
    61.1 ± 9.6
    No statistical analyses for this end point

    Secondary: QLQ BM22 painful characteristics score after 4 weeks treatment

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    End point title
    		 QLQ BM22 painful characteristics score after 4 weeks treatment
    End point description
    Secondary objective: To determine if pain-related symptoms and quality of life are improved by saracatinib . This is measured using the QLQ BM22 painful characteristics score after 4 weeks treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks on treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: 0-100
        arithmetic mean (standard deviation)
    44.4 ± 0
    38.9 ± 14.3
    No statistical analyses for this end point

    Secondary: sCTX after 4 weeks treatment

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    End point title
    		 sCTX after 4 weeks treatment
    End point description
    Secondary endpoint: To determine whether bone turnover is further reduced by saracatinib in patients already taking bisphosphonates or denosumab. This is measured studying sCTX, a biomarker of bone resorption, after 4 weeks on treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks on treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: % change from baseline
        arithmetic mean (standard deviation)
    -34.6 ± 12.9
    8.4 ± 12.6
    No statistical analyses for this end point

    Secondary: uNTX/Cr after 4 weeks treatment

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    End point title
    		 uNTX/Cr after 4 weeks treatment
    End point description
    Secondary endpoint: To determine whether bone turnover is further reduced by saracatinib in patients already taking bisphosphonates or denosumab. This is measured studying uNTX/Cr, a biomarker of bone resorption, after 4 weeks on treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: % change from baseline
        arithmetic mean (standard deviation)
    -16.0 ± 41.9
    -3.2 ± 4.6
    No statistical analyses for this end point

    Secondary: P1NP after 4 weeks treatment

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    End point title
    		 P1NP after 4 weeks treatment
    End point description
    Secondary endpoint: To determine whether bone turnover is further reduced by saracatinib in patients already taking bisphosphonates or denosumab. This is measured studying P1NP, a biomarker of bone deposition, after 4 weeks on treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks treatment
    End point values
    		 Active drug Placebo
    Number of subjects analysed
    6
    6
    Units: % change from baseline
        arithmetic mean (standard deviation)
    -12.2 ± 15.4
    7.0 ± 7.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events will be collected for all participants from the time of written informed consent until 30 days post cessation of trial therapy (including any IMP received during extended use).
    Adverse event reporting additional description
    All AEs were monitored until resolution, or if the AE was determined to be chronic, until a cause is identified. If an AE remained unresolved at the conclusion of the study, the investigator made a clinical assessment about whether continued follow-up of the AE was warranted.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Active drug
    Reporting group description
    		 Patients in the active drug arm received the study medication

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo arm

    Serious adverse events
    		 Active drug Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain Metastases
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active drug Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Foot oedema
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Neuropathic Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Confusional state
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Drowsiness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    Tiredness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal bloating
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Abdominal Cramp
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 6 (50.00%)
         occurrences all number
    2
    3
    Loose stools
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    3 / 6 (50.00%)
    2 / 6 (33.33%)
         occurrences all number
    3
    2
    Oral Thrush
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Persistent non-productive cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Wheeze
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Runny nose
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Hair loss
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Pruritus of both hands
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Night sweats
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Renal function test abnormal
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in leg
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Bone pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Sacral pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Fingers stiffness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2013
    Substantial Amendment 01: Submission of Manufacturer's Authorisation.
    12 May 2015
    Substantial Amendment 07: Update to Reference Safety Information.
    06 Aug 2015
    Substantial Amendment 08: Addition of extended use of the IMP to the protocol, this allowed participants to take the IMP for an additional 6 months if there was significant improvement in their pain scores. Participants signed an additional consent form if they entered the 'extended use' phase and AEs continued to be collected.
    22 Feb 2016
    Substantial Amendment 10: Update to Reference Safety Information and Marketing Authorisation updated to include manufacturers from Sweden.
    21 Oct 2016
    Substantial Amendment 11: Reduction in sample size and update to trial stopping rules. Addition of new site/PI.
    30 Mar 2017
    Substantial Amendment 13: SAE clarification for inpatient hospitalisation due to progression of disease. Clarification of definition of End of Trial.

    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.
    Sample size of 12 participants.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31667062
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