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    Clinical Trial Results:
    A Phase II Study with a Safety Run-in Phase Evaluating Vosaroxin With Azacitidine in Older Patients with Newly Diagnosed Acute Myeloid Leukemia and Intermediate/Adverse Genetic Risk or Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2) - AMLSG 24-15

    Summary
    EudraCT number
    		 2015-004066-28
    Trial protocol
    		 DE  
    Global end of trial date
    31 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2020
    First version publication date
    13 Nov 2020
    Other versions
    Summary report(s)
    		 AMLSG 24-15 Final report

    Trial information

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    Trial identification
    Sponsor protocol code
    AMLSG2415
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03338348
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Ulm
    Sponsor organisation address
    Albert-Einstein-Allee 23, Ulm, Germany, 89081
    Public contact
    Verena Gaidzik, Universiy Hospital Ulm, +49 73150045707, daniela.weber@uniklinik-ulm.de
    Scientific contact
    Verena Gaidzik, University Hospital Ulm, 3150045980 73150045707, daniela.weber@uniklinik-ulm.de
    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
    25 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary Efficacy Objective • The primary efficacy objective is to evaluate the effect of vosaroxin in combination with azacitidine on the rate of complete remission (CR) and CR with incomplete blood count recovery (CRi) in older (≥60 years) patients with newly diagnosed AML or MDS-EB-2, who are unlikely to benefit from standard intensive chemotherapy Key Secondary Efficacy Objective • To conduct a pre-defined subgroup analysis in older (≥60 years) patients with complex karyotype to evaluate the effect of vosaroxin in combination with azacitidine on CR and CRi Secondary Efficacy Objectives • To evaluate the rate of CR and rate of combined CR/CRi and CR with negativity for minimal residual disease (CRMRD-) • To analyze duration of response (DOR) • To evaluate event-free survival (EFS) • To evaluate overall survival (OS) Safety and QoL Objectives • Incidence and intensity of adverse events (AEs) with vosaroxin in combination with azacitidine as assess
    Protection of trial subjects
    In this study, safety was assessed by evaluating the following: reported adverse events, clinical laboratory test results, vital signs measurements, ECG findings, chest X-ray, echo scan, physical examination findings, monitoring of concomitant therapy. For each safety parameter, all findings (whether normal or abnormal) were recorded in the eCRF.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 May 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    0
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Patient in: 14.05.2018 Last Patient in: 22.05.2019 Nine patients were recruited within the safety run-in phase at 11 participating sites in Germany. On Oct 31th 2019 the study was early terminated, since the manufacturer of Vosaroxin, SUNESIS Pharmaceuticals, Inc., had discontinued the development programme of the IMP Vosaroxin.

    Pre-assignment
    Screening details
    		 Screening details: Molecular genetic analysis (central AMLSG reference lab) of blood and bone marrow was performed at baseline within 48 hours to make an enrollment possible.

    Period 1
    Period 1 title
    Safety run-in phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Study treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vosaroxin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vosaroxin is administered up to 8 cycles on day 1 to 7. Dose levels safety run-in Phase: Dose level 0: 70mg/m² Dose level -1: 50mg/m² Dose level -2: 40mg/m²

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Vidaza
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive up to 8 cycles of azacitidine at 75 mg/m²/d on days 1-7 (in combination with vosaroxin). Patients who have completed 8 cycles of azacitidine are scheduled to maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression.

    Number of subjects in period 1
    		Study treatment
    Started
    9
    Completed
    0
    Not completed
    9
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    1
         Physician decision
    1
         Allogeneic stem cell transplantation
    1
         Adverse event, non-fatal
    1
         Other reason
    1
         Lack of efficacy
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Safety run-in phase
    Reporting group description
    		 -

    Reporting group values
    		 Safety run-in phase Total
    Number of subjects
    		 9 9
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 71.4 (65.8 to 81.8) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 8 8
    Ethnicity
    Units: Subjects
        Caucasian
    		 9 9
        Asian
    		 0 0
        North African/Arabian/Turk
    		 0 0
        Other African
    		 0 0
        Other
    		 0 0
    WHO ECOG performance status
    Units: Subjects
        ECOG 0
    		 8 8
        ECOG 1
    		 0 0
        ECOG 2
    		 1 1
        ECOG 3
    		 0 0
        ECOG 4
    		 0 0
    Initial diagnosis
    Units: Subjects
        AML
    		 8 8
        MDS RAEB-2
    		 1 1
    Type of AML
    Units: Subjects
        De novo AML
    		 2 2
        Secondary AML after MDS/MPS
    		 6 6
        Treatment-related AML
    		 0 0
        Missing
    		 1 1
    ELN classification AML
    Units: Subjects
        Favorable
    		 0 0
        Intermediate
    		 1 1
        Adverse
    		 7 7
        Missing
    		 1 1
    FLT3-ITD
    Units: Subjects
        Negative
    		 8 8
        FLT3-ITD low
    		 1 1
        FLT3-ITD high
    		 0 0
    FLT3-TKD
    Units: Subjects
        Negative
    		 9 9
        Positive
    		 0 0
    NPM1
    Units: Subjects
        Wildtype
    		 9 9
        Mutation
    		 0 0
    CEBPA
    Units: Subjects
        Wildtype
    		 9 9
        Mono-allelic mutation
    		 0 0
        Bi-allelic mutation
    		 0 0
    ASXL1
    Units: Subjects
        Wildtype
    		 1 1
        Mutation
    		 3 3
        Missing
    		 5 5
    RUNX1
    Units: Subjects
        Wildtype
    		 1 1
        Mutation
    		 3 3
        Missing
    		 5 5
    TP53
    Units: Subjects
        Wildtype
    		 4 4
        Mutation
    		 0 0
        Missing
    		 5 5
    CIRS score
    Units: Points
        median (full range (min-max))
    		 2 (1 to 11) -
    LDH
    Units: U/l
        median (full range (min-max))
    		 219 (119 to 620) -
    Hemoglobin
    Units: g/dl
        median (full range (min-max))
    		 9.2 (7.5 to 13.2) -
    Platelets
    Units: G/l
        median (full range (min-max))
    		 77 (12 to 437) -
    White blood count
    Units: G/l
        median (full range (min-max))
    		 2.5 (0.5 to 52.8) -
    Bone marrow blast
    Units: Percent
        median (full range (min-max))
    		 25 (9 to 50) -
    Peripheral blood blast
    Units: Percent
        median (full range (min-max))
    		 0 (0 to 10) -
    Subject analysis sets

    Subject analysis set title
    ITT analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT Analysis set contains all patients enrolled into the trial

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis set contains all patients which received at least one dose of Azacitidine or Vosaroxin.

    Subject analysis sets values
    		 ITT analysis set Safety analysis set
    Number of subjects
    9
    9
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    71.4 (65.8 to 81.8)
    71.4 (65.8 to 81.8)
    Gender categorical
    Units: Subjects
        Female
    1
    1
        Male
    8
    8
    Ethnicity
    Units: Subjects
        Caucasian
    9
    9
        Asian
    0
    0
        North African/Arabian/Turk
    0
    0
        Other African
    0
    0
        Other
    0
    0
    WHO ECOG performance status
    Units: Subjects
        ECOG 0
    8
    8
        ECOG 1
    0
    0
        ECOG 2
    1
    1
        ECOG 3
    0
    0
        ECOG 4
    0
    0
    Initial diagnosis
    Units: Subjects
        AML
    8
    8
        MDS RAEB-2
    1
    1
    Type of AML
    Units: Subjects
        De novo AML
    2
    2
        Secondary AML after MDS/MPS
    6
    6
        Treatment-related AML
    0
    0
        Missing
    1
    1
    ELN classification AML
    Units: Subjects
        Favorable
    0
    0
        Intermediate
    1
    1
        Adverse
    7
    7
        Missing
    1
    1
    FLT3-ITD
    Units: Subjects
        Negative
    8
    8
        FLT3-ITD low
    1
    1
        FLT3-ITD high
    0
    0
    FLT3-TKD
    Units: Subjects
        Negative
    9
    9
        Positive
    0
    0
    NPM1
    Units: Subjects
        Wildtype
    9
    9
        Mutation
    0
    0
    CEBPA
    Units: Subjects
        Wildtype
    9
    9
        Mono-allelic mutation
    0
    0
        Bi-allelic mutation
    0
    0
    ASXL1
    Units: Subjects
        Wildtype
    1
    1
        Mutation
    3
    3
        Missing
    5
    5
    RUNX1
    Units: Subjects
        Wildtype
    1
    1
        Mutation
    3
    3
        Missing
    5
    5
    TP53
    Units: Subjects
        Wildtype
    4
    4
        Mutation
    0
    0
        Missing
    5
    5
    CIRS score
    Units: Points
        median (full range (min-max))
    2 (1 to 11)
    2 (1 to 11)
    LDH
    Units: U/l
        median (full range (min-max))
    219 (119 to 620)
    219 (119 to 620)
    Hemoglobin
    Units: g/dl
        median (full range (min-max))
    9.2 (7.5 to 13.2)
    9.2 (7.5 to 13.2)
    Platelets
    Units: G/l
        median (full range (min-max))
    77 (12 to 437)
    77 (12 to 437)
    White blood count
    Units: G/l
        median (full range (min-max))
    2.5 (0.5 to 52.8)
    2.5 (0.5 to 52.8)
    Bone marrow blast
    Units: Percent
        median (full range (min-max))
    25 (9 to 50)
    25 (9 to 50)
    Peripheral blood blast
    Units: Percent
        median (full range (min-max))
    0 (0 to 10)
    0 (0 to 10)

    End points

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    End points reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 -

    Subject analysis set title
    ITT analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT Analysis set contains all patients enrolled into the trial

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis set contains all patients which received at least one dose of Azacitidine or Vosaroxin.

    Primary: Rate of complete remission / complete remission with incomplete hematological recovery

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    End point title
    		 Rate of complete remission / complete remission with incomplete hematological recovery [1]
    End point description
    End point type
    Primary
    End point timeframe
    during treatment phase (12 months)
    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: Primary and secondary efficacy variables were not analyzed due to premature termination of the trial.
    End point values
    		 Study treatment ITT analysis set Safety analysis set
    Number of subjects analysed
    9
    9
    9
    Units: Patients
        CR/CRi
    4
    4
    4
        No response
    5
    5
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During treatment cycles and maintenance therapy (12 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Overall treatment period
    Reporting group description
    		 -

    Serious adverse events
    		 Overall treatment period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    1
    Investigations
    Other (Hepatic enzymes increased)
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Other (Bifascicular block)
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Mucositis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    Urinary tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall treatment period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    Vascular disorders
    Hematoma
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Hypertension
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    5
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Superficial thrombophlebitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Edema limbs
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    9
    Fatigue
         subjects affected / exposed
    5 / 9 (55.56%)
         occurrences all number
    9
    Fever
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    6
    Injection site reaction
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    13
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Prostatic obstruction
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Epistaxis
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Hiccups
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hypoxia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pneumonitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    8
    Restlessness
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Investigations
    Creatinine increased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Electrocardiogram QT corrected interval prolonged
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Other (LDH increase)
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Neutrophil count decreased
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    22
    Platelet count decreased
         subjects affected / exposed
    9 / 9 (100.00%)
         occurrences all number
    27
    Weight gain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    White blood cell decreased
         subjects affected / exposed
    8 / 9 (88.89%)
         occurrences all number
    27
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Other
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    5
    Syncope
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    9 / 9 (100.00%)
         occurrences all number
    32
    Other
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Febrile neutropenia
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    4
    Leukocytosis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Lymph node pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Scleral disorder
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    10
    Diarrhea
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    5
    Dry mouth
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Mukositis oral
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    15
    Oral hemorrhage
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Periodontal disease
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Stomach pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Rash akneiform
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Rash maculo-papular
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4
    Other
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    4
    Skin ulceration
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Renal and urinary disorders
    Other (fluid retention, edema)
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Urinary incontinence
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Chest wall pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Infections and infestations
    Enterocolitis infectious
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Other
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Lip infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Mucosal infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Sepsis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Tooth infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    6
    Hypoalbuminemia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Hypocalcemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Hypokalemia
         subjects affected / exposed
    7 / 9 (77.78%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    On October 31st 2019 the study was early terminated, since the manufacturer of vosaroxin, SUNESIS Pharmaceuticals, Inc., had discontinued the development program of the IMP. Primary and secondary efficacy variables were not analyzed.
    For support, Contact us.
    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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