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    Clinical Trial Results:
    A Mechanistic Study Of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma

    Summary
    EudraCT number
    		 2012-000615-84
    Trial protocol
    		 IT   NL   DE  
    Global end of trial date
    09 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Aug 2017
    First version publication date
    16 Aug 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OCTO_039
    Additional study identifiers
    ISRCTN number
    		 ISRCTN46249783
    US NCT number
    		 NCT02441309
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Joint Research Office, Block 60, Churchill Hospital, Oxford, United Kingdom, OX3 7LE
    Public contact
    Joint Research Office, University of Oxford, ctrg@admin.ox.ac.uk
    Scientific contact
    Joint Research Office, University of Oxford, ctrg@admin.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
    19 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The principal research question is to identify markers of response to mifurmatide by looking at biological markers of immune response activation in tumour biopsies taken before and after 6 weeks of treatment. The pharmacodynamic readouts will be compared with radiological (CT scan) response measured by standard RECIST criteria.
    Protection of trial subjects
    The Sponsor and Investigators ensured that the protocol was conducted in compliance with the European 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 (2013) and the regulatory requirements for clinical trials of an investigational medicinal product under the European Union Clinical Trials Directive. The protocol, patient information sheet and consent form was reviewed and approved by an appropriately constituted, UK independent Research Ethics Committee (REC) or national equivalent. Approval to conduct the study was obtained from the relevant Competent Authority in each participating country prior to initiating the study. The Investigators monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study. Adverse event monitoring starts from the time the patient consents to the study until they complete the trial.
    Background therapy
    		 There is currently no approved treatment other than surgery for metastatic or recurrent osteosarcoma refractory to chemotherapy. Patients deemed unresectable normally receive chemotherapy prior to attempted resection.
    Evidence for comparator
    		 Mifamurtide is licensed for use in the adjuvant osteosarcoma setting, The addition of chemotherapy to surgery may improve response rates. This trial will investigate why some patients with osteosarcoma may respond better than others to mifamurtide given alone or in combination with ifosfamide. All participants will receive 36 weeks or more of mifamurtide.
    Actual start date of recruitment
    15 Jul 2015
    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
    Netherlands: 1
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    1
    Adults (18-64 years)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment opened in October 2014 with the first patient being recruited on the 15th July 2015. The trial closed in June 2016 due to a poor recruitment rate.

    Pre-assignment
    Screening details
    		 18 Patients were assessed for eligibility. 10 patients were excluded, 4 did not meet the inclusion/exclusion criteria and 6 declined to participate.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Resectable Cohort
    Arm description
    		 Patients who were deemed resectable at registration were placed in this group. They received Mifamurtide alone with the option to have surgeries at baseline and after 6 weeks (2 cycles) of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mifamurtide
    Investigational medicinal product code
    Mifamurtide
    Other name
    MEPACT
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weeks 1-12 (cycles 1-4): Mifamurtide 2 mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks. Weeks 13-36 ( cycles 5-12): Mifamurtide 2 mg/m2, IV infusion, once per week.

    Arm title
    		 Unresectable Control arm
    Arm description
    		 Unresectable patients who were allocated to received mifamurtide after the primary endpoint timepoint (6 weeks or 2 cycles of treatment). Patients received Ifosfamide for 4 three weekly cycles. Patients received 12 3 weekly cycles of Mifamurtide starting after completing 2 cycles of Ifosfamide.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mifamurtide
    Investigational medicinal product code
    Mifamurtide
    Other name
    MEPACT
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    weeks 7-18 (cycles 3-6): Mifamurtide 2 mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks. weeks 19-42 (cycles 7-14): Mifamurtide 2 mg/m2, IV infusion, once per week.

    Investigational medicinal product name
    Ifosfamide
    Investigational medicinal product code
    Ifosfamide
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Day 1 of each a 21 day cycle: Ifosfamide 12-15 g/m2 IV infusion infused over 4-5 days as per local practice. Repeated every 21 days for two cycles (3 weeks = 1 cycle). Ifosfamide administered as per local institutional practice, including concurrent dosing with mesna.

    Arm title
    		 Unresectable Experimental Arm
    Arm description
    		 Unresectable patients allocated to this arm received 4 three weekly cycles of Ifosfamide and 12 three weekly cycles of Mifamurtide both starting at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mifamurtide
    Investigational medicinal product code
    Mifamurtide
    Other name
    MEPACT
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weeks 1-12 (cycles 1-4): Mifamurtide 2 mg/m2, IV infusion, twice per week, with each infusion given at least 3 days apart, for 6 weeks. Weeks 13-36 ( cycles 5-12): Mifamurtide 2 mg/m2, IV infusion, once per week.

    Investigational medicinal product name
    Ifosfamide
    Investigational medicinal product code
    Ifosfamide
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Day 1 of each a 21 day cycle: Ifosfamide 12-15 g/m2 IV infusion infused over 4-5 days as per local practice. Repeated every 21 days for two cycles (3 weeks = 1 cycle). Ifosfamide administered as per local institutional practice, including concurrent dosing with mesna.

    Number of subjects in period 1
    		Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Started
    3
    2
    3
    6 week scan (primary endpoint)
    1
    1
    2
    Completed
    0
    0
    0
    Not completed
    3
    2
    3
         Consent withdrawn by subject
    1
    -
    1
         Adverse event, non-fatal
    -
    1
    -
         Lack of efficacy
    2
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main study
    Reporting group description
    		 -

    Reporting group values
    		 Main study Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 24.5 (20.2 to 34.5) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 7 7
    WHO Performance Status
    Units: Subjects
        WHO ps 0
    		 6 6
        Who ps 1
    		 2 2
    Histology/ Cytological type
    Units: Subjects
        Chondroblastic OS - 9181/3
    		 1 1
        Osteoblastic OS - 9180/3
    		 2 2
        Osteosarcoma NOS - 9180/3
    		 5 5
    Primary Site
    Units: Subjects
        Axial
    		 3 3
        Limb
    		 5 5
    Disease stage at screening
    Units: Subjects
        Metastatic
    		 8 8
    Prior Chemotherapy
    Units: Subjects
        Yes
    		 2 2
        No
    		 6 6
    Prior Radiotherapy
    Units: Subjects
        Yes
    		 8 8
    Prior Surgery
    Units: Subjects
        Yes
    		 8 8
    Tumour size at baseline (sum of longest diameters)
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 82 (51 to 92) -

    End points

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    End points reporting groups
    Reporting group title
    Resectable Cohort
    Reporting group description
    		 Patients who were deemed resectable at registration were placed in this group. They received Mifamurtide alone with the option to have surgeries at baseline and after 6 weeks (2 cycles) of treatment.

    Reporting group title
    Unresectable Control arm
    Reporting group description
    		 Unresectable patients who were allocated to received mifamurtide after the primary endpoint timepoint (6 weeks or 2 cycles of treatment). Patients received Ifosfamide for 4 three weekly cycles. Patients received 12 3 weekly cycles of Mifamurtide starting after completing 2 cycles of Ifosfamide.

    Reporting group title
    Unresectable Experimental Arm
    Reporting group description
    		 Unresectable patients allocated to this arm received 4 three weekly cycles of Ifosfamide and 12 three weekly cycles of Mifamurtide both starting at baseline.

    Primary: Radiological Response Defined as Complete or Partial Response and Assessed Using RECIST Criteria

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    End point title
    		 Radiological Response Defined as Complete or Partial Response and Assessed Using RECIST Criteria [1]
    End point description
    Radiological response defined as complete or partial response and assessed using RECIST criteria
    End point type
    Primary
    End point timeframe
    Change from Baseline to after 6 weeks of 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: The trial halted early and thus no statistical analysis was completed.
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    3
    2
    3
    Units: subjects
        Stable disease
    0
    1
    1
        Progressive disease
    0
    0
    1
        Patient did not reach endpoint
    1
    1
    1
        Patient progression prior to endpoint
    2
    0
    0
    No statistical analyses for this end point

    Primary: Biological Response Data Based on Pharmacodynamic Endpoints on Tumour Biopsy Material

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    End point title
    		 Biological Response Data Based on Pharmacodynamic Endpoints on Tumour Biopsy Material [2]
    End point description
    Biological response data based on pharmacodynamic endpoints on tumour biopsy material including macrophage infiltration and innate immune activation.
    End point type
    Primary
    End point timeframe
    Change from Baseline to after 6 weeks of 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: This endpoint has not yet been completed.
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    Units: Macrophage count
        median (full range (min-max))
    ( to )
    ( to )
    ( to )
    Notes
    [3] - Endpoint currently being analysed
    [4] - Endpoint currently being analysed
    [5] - Endpoint currently being analysed
    No statistical analyses for this end point

    Secondary: Objective Radiological Response Based on RECIST 1.1 (week 12)

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    End point title
    		 Objective Radiological Response Based on RECIST 1.1 (week 12)
    End point description
    Objective radiological response based on RECIST 1.1
    End point type
    Secondary
    End point timeframe
    Change from Baseline to after 12 weeks of treatment
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    3
    2
    3
    Units: subjects
        Stable disease
    0
    1
    1
        Progressive disease
    0
    0
    0
        Patient did not reach endpoint
    3
    1
    2
    No statistical analyses for this end point

    Secondary: Objective Radiological Response Based on RECIST 1.1 (week 18)

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    End point title
    		 Objective Radiological Response Based on RECIST 1.1 (week 18)
    End point description
    Objective radiological response based on RECIST 1.1
    End point type
    Secondary
    End point timeframe
    from Baseline to after 18 weeks of treatment
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    3
    2
    3
    Units: subjects
        Stable disease
    0
    1
    0
        Progressive disease
    0
    0
    1
        Patient did not reach endpoint
    3
    1
    2
    No statistical analyses for this end point

    Secondary: Objective Radiological Response Based on RECIST 1.1 (week 24)

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    End point title
    		 Objective Radiological Response Based on RECIST 1.1 (week 24)
    End point description
    Objective radiological response based on RECIST 1.1
    End point type
    Secondary
    End point timeframe
    Change from Baseline to after 24 weeks of treatment
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    3
    2
    3
    Units: subjects
        Stable disease
    0
    1
    0
        Progressive disease
    0
    0
    0
        Patient did not reach endpoint
    3
    1
    3
    No statistical analyses for this end point

    Secondary: Objective Radiological Response Based on RECIST 1.1 (week 36)

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    End point title
    		 Objective Radiological Response Based on RECIST 1.1 (week 36)
    End point description
    Objective radiological response based on RECIST 1.1
    End point type
    Secondary
    End point timeframe
    Change from Baseline to after 36 weeks of treatment
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    3
    2
    3
    Units: subjects
        Stable disease
    0
    0
    0
        Progressive disease
    0
    1
    0
        Patient did not reach endpoint
    3
    1
    3
    No statistical analyses for this end point

    Secondary: Laboratory Abnormalities (Grade 3-4)

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    End point title
    		 Laboratory Abnormalities (Grade 3-4)
    End point description
    Laboratory abnormalities grade 3 and 4
    End point type
    Secondary
    End point timeframe
    Up to 42 weeks
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    3
    2
    3
    Units: subjects
        Yes
    0
    0
    0
        No
    3
    2
    3
    No statistical analyses for this end point

    Secondary: Disease Specific Overall Survival

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    End point title
    		 Disease Specific Overall Survival
    End point description
    The time from registration/randomisation to death due to the disease. Surviving patients and deaths due to other cause will be censored at their last follow-up date. Patients lost to Follow-up without an event will be censored at the date of their last consultation.
    End point type
    Secondary
    End point timeframe
    Up to 42 weeks
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [6] - Trial Stopped early, endpoint not analysed
    [7] - Trial Stopped early, endpoint not analysed
    [8] - Trial Stopped early, endpoint not analysed
    No statistical analyses for this end point

    Secondary: Toxicity (Graded According to the CTCAE Criteria)

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    End point title
    		 Toxicity (Graded According to the CTCAE Criteria)
    End point description
    Grade 3+ Toxicity measured and graded according to the CTCAE criteria
    End point type
    Secondary
    End point timeframe
    Up to 42 weeks
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    3
    2
    3
    Units: subjects
        Experiences a grade 3+ adverse event
    0
    2
    2
    No statistical analyses for this end point

    Secondary: Progression Free Survival on Serial CT Scan

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    End point title
    		 Progression Free Survival on Serial CT Scan
    End point description
    Time from randomisation for deemed non-resectable groups, or time from registration for deemed resectable group to first event, where an event is progression as (defined by RECIST criterion) or death due to any cause. Patients who have not had an event will be censored at their last follow-up date. Patients lost to follow-up without an event will be censored at the date of their last consultation.
    End point type
    Secondary
    End point timeframe
    Up to 42 weeks
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [9] - Trial Stopped early, endpoint not analysed
    [10] - Trial Stopped early, endpoint not analysed
    [11] - Trial Stopped early, endpoint not analysed
    No statistical analyses for this end point

    Secondary: Objective Radiological Response Based on RECIST 1.1 (end of treatment prior to week 6)

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    End point title
    		 Objective Radiological Response Based on RECIST 1.1 (end of treatment prior to week 6)
    End point description
    Objective radiological response based on RECIST 1.1
    End point type
    Secondary
    End point timeframe
    Change from Baseline to end of treatment visit before week 6
    End point values
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Number of subjects analysed
    2
    0 [12]
    0 [13]
    Units: Patients
        Stable disease
    0
        Progressive disease
    2
    Notes
    [12] - No patient had a end of treatment scan prior to week 6
    [13] - No patient had a end of treatment scan prior to week 6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from baseline until discontinuation of all trial treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Resectable Cohort
    Reporting group description
    		 Patients who were deemed resectable at registration were placed in this group. They received Mifamurtide alone with the option to have surgeries at baseline and after 6 weeks (2 cycles) of treatment.

    Reporting group title
    Unresectable Control arm
    Reporting group description
    		 Unresectable patients who were allocated to received mifamurtide after the primary endpoint timepoint (6 weeks or 2 cycles of treatment). Patients received Ifosfamide for 4 three weekly cycles. Patients received 12 3 weekly cycles of Mifamurtide starting after completing 2 cycles of Ifosfamide.

    Reporting group title
    Unresectable Experimental Arm
    Reporting group description
    		 Unresectable patients allocated to this arm received 4 three weekly cycles of Ifosfamide and 12 three weekly cycles of Mifamurtide both starting at baseline.

    Serious adverse events
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 2 (100.00%)
    2 / 3 (66.67%)
         number of deaths (all causes)
    0
    0
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pseudomonas infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Resectable Cohort Unresectable Control arm Unresectable Experimental Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    4
    1
    Taste altered
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    8
    1
    Fever
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Flu like symptoms
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    3
    0
    Shivering
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Shortness of breath
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Muscle weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Central line infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Infected toe
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    5
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    3
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Apr 2015
    Amend the protocol inclusion/ exclusion criteria and the statistical considerations for the trial in order to optimise the trial's design. Also the addition of four new sites.
    16 Dec 2015
    Updated to allow for an alternative GFR renal function screening assessment technique and an alternative cardiological screening assessment technique.
    27 Jul 2016
    Early closure of recruitment.

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

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

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