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    Clinical Trial Results:
    A Phase 2a, Multi-centre, Single-arm Trial of the combination of AZD2014 and Weekly Paclitaxel in Patients with Relapsed or Refractory Squamous Non-Small Cell Lung Cancer After at Least One Line of Prior Therapy

    Summary
    EudraCT number
    		 2015-000159-26
    Trial protocol
    		 ES  
    Global end of trial date
    29 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jan 2018
    First version publication date
    12 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2274C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02403895
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85, Sodertalje, Sweden,
    Public contact
    Medical Science Director, AstraZeneca, clinicaltrialtransparency@astrazeneca.com
    Scientific contact
    Medical Science Director, AstraZeneca, clinicaltrialtransparency@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of the combination of AZD2014 and weekly paclitaxel in patients with squamous cell Non Small Cell Lung Cancer (NSCLC) by evaluation of objective response rate (ORR)
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation Good Clinical Practice and applicable regulatory requirements and the AstraZeneca policy on Bioethics
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Spain: 2
    Worldwide total number of subjects
    11
    EEA total number of subjects
    5
    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)
    8
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject enrolled: 15 April 2015 Last subject last visit: 29 December 2016 The study was performed at 7 centres: 4 USA, 2 Spain, 1 Germany Patient population: Patients with squamous non-small cell lung cancer with relapsed or refractory disease for whom weekly paclitaxel is an appropriate treatment choice

    Pre-assignment
    Screening details
    		 11 patients were enrolled Patients were assigned to treatment if they met all of the inclusion criteria and none of the exclusion criteria

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

    Arms
    Arm title
    		 Open-label AZD2014
    Arm description
    		 Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
    Arm type
    		 Experimental

    Investigational medicinal product name
    vistusertib
    Investigational medicinal product code
    AZD2014
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg BD Weekly Intermittent Schedule 3 days on, 4 days off

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    80mg/m2 weekly for 6 weeks of 7 week cycle

    Number of subjects in period 1
    		Open-label AZD2014
    Started
    11
    Completed
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-label AZD2014
    Reporting group description
    		 Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel

    Reporting group values
    		 Open-label AZD2014 Total
    Number of subjects
    		 11 11
    Age Categorical
    Units: Subjects
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 8 8
        >=65 years
    		 3 3
    Age continuous
    Units: years
        median (full range (min-max))
    		 62.0 (49 to 80) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 1 1
        Male
    		 10 10
    Race
    Units: Subjects
        White
    		 9 9
        Black or African American
    		 1 1
        Other
    		 1 1
    Ethnic Group
    Units: Subjects
        Not Hispanic or Latino
    		 11 11
    Height
    Units: cm
        median (full range (min-max))
    		 172 (154 to 180) -
    Weight
    Units: kg
        median (full range (min-max))
    		 70 (62 to 125) -
    Body Mass Index (BMI)
    Units: kg/m2
        median (full range (min-max))
    		 25.71 (20.96 to 39.45) -
    Subject analysis sets

    Subject analysis set title
    Evaluable for efficacy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All dosed patients with a baseline tumour assessment of measurable disease

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who recieved at least 1 dose of AZD2014

    Subject analysis sets values
    		 Evaluable for efficacy Safety
    Number of subjects
    11
    11
    Age Categorical
    Units: Subjects
        <=18 years
    0
    0
        Between 18 and 65 years
    8
    8
        >=65 years
    3
    3
    Age continuous
    Units: years
        median (full range (min-max))
    62.0 (49 to 80)
    62.0 (49 to 80)
    Sex: Female, Male
    Units: Subjects
        Female
    1
    1
        Male
    10
    10
    Race
    Units: Subjects
        White
    9
    9
        Black or African American
    1
    1
        Other
    1
    1
    Ethnic Group
    Units: Subjects
        Not Hispanic or Latino
    11
    11
    Height
    Units: cm
        median (full range (min-max))
    172 (154 to 180)
    172 (154 to 180)
    Weight
    Units: kg
        median (full range (min-max))
    70 (62 to 125)
    70 (62 to 125)
    Body Mass Index (BMI)
    Units: kg/m2
        median (full range (min-max))
    25.71 (20.96 to 39.45)
    25.71 (20.96 to 39.45)

    End points

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    End points reporting groups
    Reporting group title
    Open-label AZD2014
    Reporting group description
    		 Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel

    Subject analysis set title
    Evaluable for efficacy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All dosed patients with a baseline tumour assessment of measurable disease

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who recieved at least 1 dose of AZD2014

    Primary: Anti-tumour activity through calculation of the percentage of patients who have a Partial Response or Complete response through measurement of tumour lesion sizes

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    End point title
    		 Anti-tumour activity through calculation of the percentage of patients who have a Partial Response or Complete response through measurement of tumour lesion sizes
    End point description
    Calculation of the percentage of patient who have a Complete Response or Partial Response to treatment which is confirmed by a repeat assessment 4 weeks later
    End point type
    Primary
    End point timeframe
    From first dose until disease progression (Approximately 3 months)
    End point values
    		 Open-label AZD2014 Evaluable for efficacy
    Number of subjects analysed
    11
    11
    Units: Percent
    number (confidence interval 90%)
        CR
    0 (0 to 23.8)
    0 (0 to 23.8)
        PR
    0 (0 to 23.8)
    0 (0 to 23.8)
    Statistical analysis title
    		 Statistical Analysis of Objective Response Rate
    Statistical analysis description
    Objective response rate (proportion of subjects with CR or PR) were summarised Two-sided 90% Clopper-Pearson confidence intervals was provided for the objective respoonse rate
    Comparison groups
    Open-label AZD2014 v Evaluable for efficacy
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimation of percentage
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 23.8

    Secondary: Number of patients experiencing adverse events (AE) and Serious Adverse Events (SAEs) including chemistry, haematology, vital signs and ECG variables

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    End point title
    		 Number of patients experiencing adverse events (AE) and Serious Adverse Events (SAEs) including chemistry, haematology, vital signs and ECG variables
    End point description
    The safety and tolerability of AZD2014 with weekly paclitaxel will be assessed with the collection of AEs/SAEs, clinical chemistry/haematology/coagulation, vital signs, and ECG parameters
    End point type
    Secondary
    End point timeframe
    Informed consent until end of safety follow up (Approx 10 months if all treatment cycles are completed)
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    11
    Units: Participants
        Any AE
    11
        Any SAE
    4
    No statistical analyses for this end point

    Secondary: Duration of Overall Survival

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    End point title
    		 Duration of Overall Survival
    End point description
    Assessment of the duration of overall survival through patient follow-up
    End point type
    Secondary
    End point timeframe
    From first dose until end of life (Approx 9 months)
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    0 [1]
    Units: Weeks
        number (not applicable)
    Notes
    [1] - Overall survival not analysed due to early termination of the study after 11 patients enrolled
    No statistical analyses for this end point

    Secondary: Anti-tumour activity through assessment of Best Objective Response by assessment of tumour lesions

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    End point title
    		 Anti-tumour activity through assessment of Best Objective Response by assessment of tumour lesions
    End point description
    Assessment of the best tumour response through assessment of tumour lesions by RECIST 1.1 criteria
    End point type
    Secondary
    End point timeframe
    From Baseline until Disease Progression (Approx 3 months)
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    11
    Units: Participants
        CR
    0
        PR
    0
        SD
    5
        PD
    6
    No statistical analyses for this end point

    Secondary: Anti-tumour activity through assessment of Duration of Response by assessment of tumour lesions

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    End point title
    		 Anti-tumour activity through assessment of Duration of Response by assessment of tumour lesions
    End point description
    Assessment of the duration of tumour response through assessment of tumour lesions by RECIST 1.1 criteria
    End point type
    Secondary
    End point timeframe
    From date of first documented response until documented progression or end of life in the absence of progression (Approx 3 months)
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    0 [2]
    Units: Days
        number (not applicable)
    Notes
    [2] - No data for analysis - 0 of 11 subjects responded to treatment
    No statistical analyses for this end point

    Secondary: Anti-tumour activity through assessment of Disease Control Rate by measurement of the number of patients who achieve Partial Response, Complete Response or Stable Disease through assessment of tumour lesions

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    End point title
    		 Anti-tumour activity through assessment of Disease Control Rate by measurement of the number of patients who achieve Partial Response, Complete Response or Stable Disease through assessment of tumour lesions
    End point description
    Assessment of the disease control rate, number of patients who experience a response through assessment of tumour lesions by RECIST 1.1 criteria
    End point type
    Secondary
    End point timeframe
    From first dose until documented progression and at least 7 weeks after the start of treatment for assessment of Stable Disease (Approx 3 months)
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    11
    Units: Percentage
    number (confidence interval 80%)
        Disease control rate at 6 weeks
    45.5 (24.1 to 68.2)
        Disease control rate at 13 weeks
    18.2 (4.9 to 41.5)
        Disease control rate at 20 weeks
    18.2 (4.9 to 41.5)
    No statistical analyses for this end point

    Secondary: Anti-tumour activity through assessment of percentage change in tumour size by measurement of tumour lesions

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    End point title
    		 Anti-tumour activity through assessment of percentage change in tumour size by measurement of tumour lesions
    End point description
    Assessment of the degree of tumour response through measurement of the change in tumour lesion sizes
    End point type
    Secondary
    End point timeframe
    From baseline until documented progression (Approx 3 months)
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    0 [3]
    Units: mm
        number (not applicable)
    Notes
    [3] - Anti-tumour activity not analysed due to early termination of study after 11 patients
    No statistical analyses for this end point

    Secondary: Anti-tumour activity through assessment of duration of progression free survival by measurement of tumour lesions

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    End point title
    		 Anti-tumour activity through assessment of duration of progression free survival by measurement of tumour lesions
    End point description
    Assessment of the duration of progression free survival through assessment of tumour lesions by RECIST 1.1 criteria
    End point type
    Secondary
    End point timeframe
    From date of first dose until documented progression or end of life (Approx 3 months)
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    0 [4]
    Units: Days
        number (not applicable)
    Notes
    [4] - Progression Free Survival not analysed due to early termination of study after 11 patients
    No statistical analyses for this end point

    Secondary: Evaluate the effect of the combination of AZD2014 and paclitaxel on pharmacokinetics which may include assessment of AUC (Area Under Curve) and levels of plasma concentration over time (Cmax, tmax, tlast, Cinf)

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    End point title
    		 Evaluate the effect of the combination of AZD2014 and paclitaxel on pharmacokinetics which may include assessment of AUC (Area Under Curve) and levels of plasma concentration over time (Cmax, tmax, tlast, Cinf)
    End point description
    To determine the effect of co-administration of paclitaxel on the PK of oral AZD2014 and the effect of co administration of oral AZD2014 on the PK of paclitaxel (Group A) by: PK parameters for each in the presence and absence of the other by intensive PK sampling and NCA techniques.
    End point type
    Secondary
    End point timeframe
    Assessment at multiple timepoints in Group A patients. Samples will be taken at pre-dose and at 10 further timepoints on day 1 and at pre-dose and 9 further timepoints on days 3 and 8
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    0 [5]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    Notes
    [5] - Outcome not measured due to early termination of the study - data insufficient
    No statistical analyses for this end point

    Secondary: Estimated pharmacokinetic exposure to AZD2014 through the use of population PK modelling

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    End point title
    		 Estimated pharmacokinetic exposure to AZD2014 through the use of population PK modelling
    End point description
    Group B patients: PK parameters for AZD2014 estimated from a sparse PK sampling regimen and use of population PK modelling techniques (may be reported outside the clinical study report (CSR))
    End point type
    Secondary
    End point timeframe
    Assessment at multiple timepoints in Group B patients between study day 1 and day 3. Samples will be taken at 3 points on day 1 and at predose and at a further 2 points on day 3
    End point values
    		 Open-label AZD2014
    Number of subjects analysed
    0 [6]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    Notes
    [6] - Outcome not measured due to early termination of the study - data insufficient
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from the time of informed consent throughout the treatment period until the end of the follow-up period (28 days after discontinuation of study treatment).
    Adverse event reporting additional description
    Adverse events were assessed systematically through clinical review, and collection of laboratory assessment, physical examination, performance status, ECHO/MUGA and ECG. Patients attended the clinic for assessment on a weekly basis
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Open-label AZD2014
    Reporting group description
    		 Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel

    Serious adverse events
    		 Open-label AZD2014
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 11 (36.36%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
         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
    		 Open-label AZD2014
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Spinal compression fracture
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nervous system disorders
    Peripheral Neuropathy
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nerve compression
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    4
    Leukopenia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    4
    Mucosal Inflammation
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    5
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Abdominal distension
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    4
    Dyspepsia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    5
    Dyspnoea
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Pulmonary Embolism
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Dyspnea exertional
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Haemoptysis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hypoxia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nasal dryness
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Papule
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Eating disorder symptom
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Bone pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Spinal Column Stenosis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Fungal Infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Increased appetite
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2015
    Based on emerging data the restriction on CYP2C8 inhibitor or inducer concomitant medications was removed

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Feb 2016
    Sponsor decision to stop further recruitment on the basis of futility due to a lack of response (0 of 11 patients) seen in the 50mg cohort
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Sponsor and Investigator decision was taken to terminate further recruitment into the study due to lack of observed responses rendering it futile to continue. As such, an abbreviated Clinical Study Report was produced based on data from 11 patients.
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