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    Clinical Trial Results:
    A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/-nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer

    Summary
    EudraCT number
    		 2013-004968-56
    Trial protocol
    		 GB  
    Global end of trial date
    07 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2023
    First version publication date
    28 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OCTO_063
    Additional study identifiers
    ISRCTN number
    		 ISRCTN50083238
    US NCT number
    		 NCT02024009
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    1st floor, Boundary Brook House Churchill Drive, Headington, Oxford, United Kingdom, OX3 7GB
    Public contact
    SCALOP-2 Clinical Trial Coordinator, Oncology Clinical Trials Office, 0044 1865617078, octo-scalop-2@oncology.ox.ac.uk
    Scientific contact
    SCALOP-2 Clinical Trial Coordinator, Oncology Clinical Trials Office, 0044 1865617078, octo-scalop-2@oncology.ox.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
    27 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of Stage 1 was to determine the Maximum Tolerated Dose (MTD) of nelfinavir to be administered alongside chemoradiotherapy and therefore to establish the dose of nelfinavir to be taken forward into Stage 2. There are 2 co-principal research objectives of Stage 2 which are: 1. Does increasing radiotherapy dose schedule from 50.4Gy (in 28 fractions) to 60Gy (in 30 fractions) improve the overall survival (OS) in LAPC? 2. Does the addition of nelfinavir to chemoradiotherapy improve progression free survival (PFS) in locally advanced non-metastatic pancreatic cancer? The aim is to select the best chemoradiotherapy regimen/s that can be taken forward to compare against chemotherapy alone in order to define the best treatment for this group of patients.
    Protection of trial subjects
    The protocol was conducted in compliance with the UK Clinical Trials Regulations, the Principles of Good Clinical Practice (GCP) and the applicable policies of the sponsoring organisation. Together, these implement the ethical principles of the Declaration of Helsinki (1996) and the regulatory requirementsfor clinical trials of investigational medicinal products under the European Union Clinical Trials Directive.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2016
    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: 159
    Worldwide total number of subjects
    159
    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)
    61
    From 65 to 84 years
    98
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient recruited was on 18Aug2017 and the last patient recruited was on 10Mar2020. The expected end of recruitment was May 2020 but due to the COVID-19 pandemic and remaining trial timelines, a decision was made to close recruitment early.

    Pre-assignment
    Screening details
    		 At least 559 participants were assessed for eligibility and consent, 400 (71.6%) were excluded from recruitment, of whom 377 were either ineligible or declined consent or eligible but did not proceed to be registered or not consented for other reasons.

    Period 1
    Period 1 title
    Full trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Capecitabine (830mg/m2 oral bd) + nelfinavir + 50.4Gy in 28#
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    capecitabine (830mg/m2 oral bd) for 28 days

    Arm title
    		 Arm B
    Arm description
    		 Capecitabine (830mg/m2 oral bd) + 50.4Gy in 28#
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    capecitabine (830mg/m2 oral bd) for 28 days

    Arm title
    		 Arm C
    Arm description
    		 Capecitabine (830mg/m2 oral bd) + nelfinavir** + 60Gy in 30#
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    capecitabine (830mg/m2 oral bd) for 30 days

    Arm title
    		 Arm D
    Arm description
    		 Capecitabine (830mg/m2 oral bd) + 60Gy in 30#
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    capecitabine (830mg/m2 oral bd) for 30 days

    Number of subjects in period 1 [1]
    		Arm A Arm B Arm C Arm D
    Started
    19
    26
    19
    27
    Completed
    15
    23
    16
    23
    Not completed
    4
    3
    3
    4
         Patient decision
    1
    2
    -
    2
         Physician decision
    1
    -
    -
    -
         Disease progression
    1
    1
    2
    2
         Patient able to move to surgery
    1
    -
    -
    -
         Patient suitable for surgery
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The trial recruited 159 subjects and the results focus on the 91 subjects who had the therapy being studied by the trial.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + nelfinavir + 50.4Gy in 28#

    Reporting group title
    Arm B
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + 50.4Gy in 28#

    Reporting group title
    Arm C
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + nelfinavir** + 60Gy in 30#

    Reporting group title
    Arm D
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + 60Gy in 30#

    Reporting group values
    		 Arm A Arm B Arm C Arm D Total
    Number of subjects
    		 19 26 19 27 91
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 7 14 8 10 39
        From 65-84 years
    		 12 12 11 17 52
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 70 (58 to 75) 62.5 (60 to 70) 69 (62 to 75) 69 (58 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 7 16 10 11 44
        Male
    		 12 10 9 16 47
    WHO Performance Status
    Units: Subjects
        Zero
    		 12 13 12 10 47
        One
    		 7 13 7 17 44
    Site of primary tumour
    Units: Subjects
        Head
    		 17 18 13 25 73
        Body/ Tail
    		 2 8 6 2 18
    Longest diameter of primary lesion
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 37 (30 to 43.1) 34 (29 to 43) 36 (26 to 45) 35 (26 to 45) -

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + nelfinavir + 50.4Gy in 28#

    Reporting group title
    Arm B
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + 50.4Gy in 28#

    Reporting group title
    Arm C
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + nelfinavir** + 60Gy in 30#

    Reporting group title
    Arm D
    Reporting group description
    		 Capecitabine (830mg/m2 oral bd) + 60Gy in 30#

    Primary: Overall survival by radiotherapy arms (arms A+B vs arms C+D)

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    End point title
    		 Overall survival by radiotherapy arms (arms A+B vs arms C+D)
    End point description
    An event is defined as death, patients still alive at the end of the study were censored
    End point type
    Primary
    End point timeframe
    Time from registration to event (death).
    End point values
    		 Arm A Arm B Arm C Arm D
    Number of subjects analysed
    19
    19
    19
    19
    Units: Median overall survival
        median (confidence interval 60%)
    15.1 (13.8 to 20.8)
    18.2 (14.3 to 21.6)
    15.6 (14.2 to 16.9)
    18.4 (17.5 to 21.4)
    Statistical analysis title
    		 OS Hazard Ratio
    Statistical analysis description
    Overall survival by radiotherapy arms (arms A+B vs arms C+D)
    Comparison groups
    Arm A v Arm B v Arm C v Arm D
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.68 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.13
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.4
    Notes
    [1] - one-sided
    [2] - onse-sided

    Primary: Progression Free Survival by nelfinavir arms (Arms A+C vs arms B+D)

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    End point title
    		 Progression Free Survival by nelfinavir arms (Arms A+C vs arms B+D)
    End point description
    An event is defined as disease progression or death. Patients who had not progressed or died by the end of the study were censored.
    End point type
    Primary
    End point timeframe
    Time from randomisation to event (disease progression or death)
    End point values
    		 Arm A Arm B Arm C Arm D
    Number of subjects analysed
    19
    19
    19
    19
    Units: Days
        median (confidence interval 60%)
    9.9 (7.8 to 10.2)
    12 (10.3 to 17.6)
    10.1 (9.9 to 11.6)
    11.1 (9.6 to 12.8)
    Statistical analysis title
    		 PFS Hazard ratio
    Statistical analysis description
    Progression Free Survival by nelfinavir arms (Arms A+C vs arms B+D)
    Comparison groups
    Arm A v Arm B v Arm C v Arm D
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.98
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.71
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 1.38
         upper limit
    		 2.12
    Notes
    [3] - One-sided (Arms A+C vs arms B+D)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From consent to 30 days past last treatment date
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Cape + Nelf + 50.4Gy (28#)

    Reporting group title
    Arm B
    Reporting group description
    		 Cape + 50.4Gy (28#)

    Reporting group title
    Arm C
    Reporting group description
    		 Cape + Nelf + 60.0Gy (30#)

    Reporting group title
    Arm D
    Reporting group description
    		 Cape + 60.0Gy (30#)

    Serious adverse events
    		 Arm A Arm B Arm C Arm D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 19 (52.63%)
    14 / 26 (53.85%)
    15 / 19 (78.95%)
    18 / 27 (66.67%)
         number of deaths (all causes)
    14
    17
    16
    17
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 26 (3.85%)
    1 / 19 (5.26%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    General disorders and administration site conditions
    General Disorders & Administration Site Conditions
         subjects affected / exposed
    4 / 19 (21.05%)
    4 / 26 (15.38%)
    4 / 19 (21.05%)
    7 / 27 (25.93%)
         occurrences causally related to treatment / all
    4 / 5
    2 / 4
    3 / 4
    8 / 10
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Investigations
    Investigations
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Injury, poisoning and procedural complications
    Injury; poisoning and procedural complications
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Blood and lymphatic system disorders
    Blood & Lymphatic System Disorders
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 26 (3.85%)
    2 / 19 (10.53%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Gastrointestinal disorders
    Gastrointestinal Disorders
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 26 (11.54%)
    4 / 19 (21.05%)
    7 / 27 (25.93%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
    3 / 4
    5 / 8
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Hepatobiliary disorders
    Hepatobiliary
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 26 (3.85%)
    4 / 19 (21.05%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Musculoskeletal and connective tissue disorders
    Musculoskeletal & Connective Tissue Disorders
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Infections and infestations
    Infections & Infestations
         subjects affected / exposed
    4 / 19 (21.05%)
    7 / 26 (26.92%)
    9 / 19 (47.37%)
    8 / 27 (29.63%)
         occurrences causally related to treatment / all
    2 / 6
    3 / 9
    3 / 10
    5 / 8
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Metabolism and nutrition disorders
    Metabolism & Nutrition Disorders
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 26 (0.00%)
    0 / 19 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    0 / 16
    0 / 17
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B Arm C Arm D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 19 (100.00%)
    26 / 26 (100.00%)
    19 / 19 (100.00%)
    27 / 27 (100.00%)
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    5 / 19 (26.32%)
    5 / 26 (19.23%)
    6 / 19 (31.58%)
    1 / 27 (3.70%)
         occurrences all number
    10
    13
    14
    1
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 26 (3.85%)
    0 / 19 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    General Disorders & Administration Site Conditions
         subjects affected / exposed
    18 / 19 (94.74%)
    24 / 26 (92.31%)
    15 / 19 (78.95%)
    20 / 27 (74.07%)
         occurrences all number
    51
    71
    63
    43
    Reproductive system and breast disorders
    Reproductive system and breast disorders
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    5 / 19 (26.32%)
    10 / 26 (38.46%)
    7 / 19 (36.84%)
    7 / 27 (25.93%)
         occurrences all number
    8
    21
    8
    9
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    5 / 19 (26.32%)
    5 / 26 (19.23%)
    1 / 19 (5.26%)
    3 / 27 (11.11%)
         occurrences all number
    8
    6
    1
    3
    Investigations
    Investigations
         subjects affected / exposed
    9 / 19 (47.37%)
    11 / 26 (42.31%)
    12 / 19 (63.16%)
    13 / 27 (48.15%)
         occurrences all number
    38
    32
    70
    85
    Injury, poisoning and procedural complications
    Injury; poisoning and procedural complications
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 26 (3.85%)
    2 / 19 (10.53%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    3
    2
    Cardiac disorders
    Cardiac Disorders
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 26 (11.54%)
    2 / 19 (10.53%)
    0 / 27 (0.00%)
         occurrences all number
    1
    7
    2
    0
    Nervous system disorders
    Nervous System Disorders
         subjects affected / exposed
    14 / 19 (73.68%)
    20 / 26 (76.92%)
    13 / 19 (68.42%)
    17 / 27 (62.96%)
         occurrences all number
    29
    33
    39
    23
    Blood and lymphatic system disorders
    Blood & Lymphatic System Disorders
         subjects affected / exposed
    5 / 19 (26.32%)
    12 / 26 (46.15%)
    9 / 19 (47.37%)
    13 / 27 (48.15%)
         occurrences all number
    23
    33
    26
    51
    Eye disorders
    Eye disorders
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 26 (7.69%)
    3 / 19 (15.79%)
    1 / 27 (3.70%)
         occurrences all number
    0
    3
    3
    1
    Gastrointestinal disorders
    Gastrointestinal Disorders
         subjects affected / exposed
    15 / 19 (78.95%)
    25 / 26 (96.15%)
    17 / 19 (89.47%)
    20 / 27 (74.07%)
         occurrences all number
    71
    146
    94
    82
    Hepatobiliary disorders
    Hepatobiliary
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 26 (3.85%)
    1 / 19 (5.26%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    14 / 19 (73.68%)
    17 / 26 (65.38%)
    11 / 19 (57.89%)
    18 / 27 (66.67%)
         occurrences all number
    29
    43
    24
    38
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 26 (0.00%)
    1 / 19 (5.26%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal & Connective Tissue Disorders
         subjects affected / exposed
    5 / 19 (26.32%)
    9 / 26 (34.62%)
    6 / 19 (31.58%)
    6 / 27 (22.22%)
         occurrences all number
    11
    18
    12
    6
    Infections and infestations
    Infections & Infestations
         subjects affected / exposed
    10 / 19 (52.63%)
    11 / 26 (42.31%)
    9 / 19 (47.37%)
    9 / 27 (33.33%)
         occurrences all number
    19
    20
    15
    11
    Metabolism and nutrition disorders
    Metabolism & Nutrition Disorders
         subjects affected / exposed
    9 / 19 (47.37%)
    12 / 26 (46.15%)
    9 / 19 (47.37%)
    7 / 27 (25.93%)
         occurrences all number
    11
    20
    27
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2015
    SA001: Protocol amendment to clarify Stage 1 & 2 objectives, inclusion of safety assessment in stage 2 objectives and endpoints, changes to pregnancy and contraception requirements
    27 Nov 2015
    SA002: Change of Principal Investigator
    20 Feb 2018
    SA003: (Protocol V6.0) Updates to all areas of protocol following Stage 1 completion including: adjustments to eligibility criteria, MTD declaration, time-point numbering. Update to Radiation Risk Assessment (higher overall dose), Updated SmPC for Capecitabine, Viracept (US and Canadian version) , IB for Nab-Paclitaxel submitted. Amended labels for Nelfinavir and Nab-Paclitaxel submitted. Updated PIS Stage1, Stage 2, Consent Form Stage 2, and Patient diary Stage 2, GP letters Stage 2 all updated. New Stage 2 sites added. Change of PI at Leeds.
    06 Mar 2018
    SA004: Update to PIS Stage 2 V5.0_10Oct2017 (as submitted with SubAmend003) to include details of GFR tests and risk of radiation exposure in order to obtain ARSAC approval for the trial.
    11 May 2018
    SA006: Addition of 2 new sites; The Clatterbridge Cancer Centre NHS Foundation Trust and Nottingham University Hospitals NHS Trust . Change in Principal Investigator
    22 May 2018
    SA005: Correction to number of CT scans in Radiation Risk Assessment in REC form (Part B, Section 3). Number of CT scans to be corrected back from 4 to 5. Total radiation dose has been re-calculated.
    29 Nov 2018
    SA007: Addition of 3 new sites; Milton Keynes Hospital NHS Foundation Trust, United Lincolnshire Hospitals Trust and Taunton and Somerset NHS Foundation Trust. Change in Principal Investigators
    02 Apr 2019
    SA009: Change in Principal Investigator at NHS Grampian
    28 Oct 2019
    SA008: Protocol version 7.0- reduction in sample size, removal of arm E. Option for patients to begin treatment on dose level -1.
    28 Apr 2020
    SA010: Protocol V8.0 Notification of temporary recruitment halt and Urgent Safety Measure
    28 Apr 2020
    SA011: Request to lift temporary recruitment halt

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Feb 2020
    Urgent Safety Measure implemented due to lack of efficacy of the IMP nelfinavir (identified by IDMC & approved by the TSC) , affecting arms A & C. No safety concerns regarding nelfinavir. Recruitment paused to prevent further randomisations to arms A & C. Registered patients were able to continue on the trial but were randomised to arms B or D only. Recruitment was never re-started due to the COVID-19 pandemic but patients already enrolled continued on trial treatment as per protocol V8.0.
    -

    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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