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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-label Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Subjects With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)

    Summary
    EudraCT number
    		 2018-001282-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2022
    First version publication date
    30 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E7389-G000-223
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03441360
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai, Inc.
    Sponsor organisation address
    155 Tice Boulevard, Woodcliff Lake, New Jersey, United States, 07677
    Public contact
    Eisai Medical Information, Eisai, Inc., +1 8882742378, esi_oncmedinfo@eisai.com
    Scientific contact
    Eisai Medical Information, Eisai, Inc., +1 8882742378, esi_oncmedinfo@eisai.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001261-PIP01-11
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Jan 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will be conducted as an assessment of the safety and preliminary activity of eribulin mesylate in pediatric subjects with relapsed/refractory RMS, NRSTS, or EWS to determine whether each cohort warrants further investigation.
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country, and Title 21 of the United States Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and IRB regulations and applicable sections of US 21 CFR Part 312. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Apr 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
    United States: 21
    Worldwide total number of subjects
    21
    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)
    8
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study at 38 investigative sites in the United States from 17 April 2018 to 21 January 2022.

    Pre-assignment
    Screening details
    		 A total of 24 subjects were screened, of which 1 was screen failure and 23 subjects were enrolled, out of which 21 subjects were enrolled and treated in the study and 2 were not treated due to withdrawal of consent and rapid disease progression (1 subject from each arm).

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eribulin mesylate 1.4 mg/m^2: RMS
    Arm description
    		 Pediatric subjects with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 milligrams per meter square (mg/m^2). Subjects continued to receive study therapy until progression of disease, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eribulin mesylate
    Investigational medicinal product code
    E7389
    Other name
    Eribulin Halaven
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eribulin mesylate administered as an intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2.

    Arm title
    		 Eribulin mesylate 1.4 mg/m^2: NRSTS
    Arm description
    		 Pediatric subjects with NRSTS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eribulin mesylate
    Investigational medicinal product code
    E7389
    Other name
    Eribulin Halaven
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eribulin mesylate administered as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2.

    Arm title
    		 Eribulin mesylate 1.4 mg/m^2: EWS
    Arm description
    		 Pediatric subjects with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eribulin mesylate
    Investigational medicinal product code
    E7389
    Other name
    Eribulin Halaven
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eribulin mesylate administered as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2.

    Number of subjects in period 1
    		Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Started
    8
    8
    5
    Completed
    0
    0
    0
    Not completed
    8
    8
    5
         Adverse event, non-fatal
    1
    -
    1
         Clinical disease progression
    2
    2
    -
         Radiological disease progression
    5
    6
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: RMS
    Reporting group description
    		 Pediatric subjects with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 milligrams per meter square (mg/m^2). Subjects continued to receive study therapy until progression of disease, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: NRSTS
    Reporting group description
    		 Pediatric subjects with NRSTS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: EWS
    Reporting group description
    		 Pediatric subjects with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Reporting group values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS Total
    Number of subjects
    		 8 8 5 21
    Age categorical
    Units: subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.4 ( 4.53 ) 11.8 ( 5.57 ) 13.2 ( 4.32 ) -
    Sex: Female, Male
    Units: subjects
        Female
    		 2 4 1 7
        Male
    		 6 4 4 14
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 2 2 1 5
        White
    		 5 4 2 11
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 1 1 2 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 2 1 6
        Not Hispanic or Latino
    		 5 6 3 14
        Unknown or Not Reported
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: RMS
    Reporting group description
    		 Pediatric subjects with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 milligrams per meter square (mg/m^2). Subjects continued to receive study therapy until progression of disease, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: NRSTS
    Reporting group description
    		 Pediatric subjects with NRSTS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: EWS
    Reporting group description
    		 Pediatric subjects with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Primary: Percentage of Subjects With Objective Response

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    End point title
    		 Percentage of Subjects With Objective Response [1]
    End point description
    Percentage of subjects achieving a best objective response of partial response (PR) or complete response (CR) per RECIST 1.1, by up to 24 weeks after all subjects have completed response assessment. Response assessment was determined by investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The FAS included all subjects who receive at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    From date of randomization up to first documentation of disease progression (PD) or date of death, whichever occurred first (approximately 32 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: Planned analyses for these data was descriptive only.
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    8
    8
    5
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 36.9)
    0 (0.0 to 36.9)
    0 (0.0 to 52.2)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) 

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    End point title
    		 Progression-free Survival (PFS) 
    End point description
    PFS was defined as the time from the first dose date to the date of PD or date of death (whichever occurred first). PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). The FAS included all subjects who receive at least 1 dose of study drug. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date (PCD).
    End point type
    Secondary
    End point timeframe
    From the time from the first dose date to the date of disease progression (PD) or date of death, whichever occurred first (up to approximately 32 months)
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    8
    8
    5
    Units: months
        median (confidence interval 95%)
    1.74 (1.12 to 2.86)
    1.30 (0.62 to 1.51)
    0.76 (0.59 to 4.04)
    No statistical analyses for this end point

    Secondary: Number of Subjects With any Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With any Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in subject administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a subject who was exposed to the study drug). A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or (1) reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. The safety analysis set (SAS) included all subjects who receive at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to approximately 44 months
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    8
    8
    5
    Units: subjects
        TEAEs
    8
    8
    5
        SAEs
    6
    2
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With a Shift From Baseline to Worst Post-Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade in Laboratory Value

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    End point title
    		 Number of Subjects With a Shift From Baseline to Worst Post-Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade in Laboratory Value
    End point description
    Laboratory results were graded using CTCAE Version 4.03. As per CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences. The safety analysis set included all subjects who receive at least 1 dose of study drug. Here number analyzed “n” are the subjects who were evaluable for the outcome measure for given categories with non-missing data at both baseline and any post-baseline. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to approximately 32 months
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    8
    8
    5
    Units: subjects
        Grade 0, Hemoglobin Decreased
    0
    0
    0
        Grade 1, Hemoglobin Decreased
    3
    4
    3
        Grade 2, Hemoglobin Decreased
    0
    1
    2
        Grade 3, Hemoglobin Decreased
    5
    3
    0
        Grade 4, Hemoglobin Decreased
    0
    0
    0
        Grade 0, Hemoglobin increased
    0
    0
    0
        Grade 1, Hemoglobin increased
    0
    0
    0
        Grade 2, Hemoglobin increased
    0
    0
    0
        Grade 3, Hemoglobin increased
    0
    0
    0
        Grade 4, Hemoglobin increased
    0
    0
    0
        Grade 0, White blood cells decreased
    0
    1
    0
        Grade 1, White blood cells decreased
    4
    2
    1
        Grade 2, White blood cells decreased
    2
    1
    0
        Grade 3, White blood cells decreased
    0
    2
    3
        Grade 4, White blood cells decreased
    2
    1
    1
        Grade 0, White blood cells increased
    0
    0
    0
        Grade 1, White blood cells increased
    0
    0
    0
        Grade 2, White blood cells increased
    0
    0
    0
        Grade 3, White blood cells increased
    0
    0
    0
        Grade 4, White blood cells increased
    0
    0
    0
        Grade 0, Lymphocyte count decreased
    3
    2
    0
        Grade 1, Lymphocyte count decreased
    1
    0
    0
        Grade 2, Lymphocyte count decreased
    1
    0
    3
        Grade 3, Lymphocyte count decreased
    2
    4
    2
        Grade 4, Lymphocyte count decreased
    1
    0
    0
        Grade 0, Lymphocyte count increased
    8
    4
    5
        Grade 1, Lymphocyte count increased
    0
    0
    0
        Grade 2, Lymphocyte count increased
    0
    2
    0
        Grade 3, Lymphocyte count increased
    0
    0
    0
        Grade 4, Lymphocyte count increased
    0
    0
    0
        Grade 0, Neutrophil count decreased
    1
    0
    1
        Grade 1, Neutrophil count decreased
    1
    0
    0
        Grade 2, Neutrophil count decreased
    3
    1
    0
        Grade 3, Neutrophil count decreased
    0
    1
    3
        Grade 4, Neutrophil count decreased
    2
    5
    1
        Grade 0, Platelet count decreased
    5
    6
    3
        Grade 1, Platelet count decreased
    2
    1
    2
        Grade 2, Platelet count decreased
    1
    0
    0
        Grade 3, Platelet count decreased
    0
    0
    0
        Grade 4, Platelet count decreased
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values

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    End point title
    		 Number of Subjects With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
    End point description
    The safety analysis set included all subjects who receive at least 1 dose of study drug. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to approximately 32 months
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    8
    8
    5
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Change From Baseline in Vital Signs Values

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    End point title
    		 Number of Subjects With Clinically Significant Change From Baseline in Vital Signs Values
    End point description
    The safety analysis set included all subjects who receive at least 1 dose of study drug. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to approximately 32 months
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    8
    8
    5
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Shift From Baseline to Worst Post-baseline for Lansky Play-performance Scale

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    End point title
    		 Number of Subjects With Shift From Baseline to Worst Post-baseline for Lansky Play-performance Scale
    End point description
    Reduced activities of daily living was assessed using the Lansky Play Performance Scale, where 100=fully active; 90=minor restrictions in strenuous physical activity; 80=active, gets tired more quickly; 70=greater restriction of play, less time spent in play activity; 60=up and around, active play minimal; quieter activities; 50=lying around much of the day; no active playing, all quiet play and activities; 40=mainly in bed; quiet activities; 30=bedbound; needs assistance even for quiet play; 20=sleeps often; play limited to very passive activities; 10=doesn't play or get out of bed; 5=unresponsive 0=dead. The safety analysis set included all subjects who receive at least 1 dose of study drug. Here overall number analyzed “N” are the subjects who were evaluable for the outcome measure with non-missing data at both baseline and any post-baseline timepoint. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 32 months
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    7
    7
    4
    Units: subjects
        Baseline: 70 to worst post-baseline: 50
    1
    0
    0
        Baseline: 70 to worst post-baseline: 60
    0
    0
    0
        Baseline: 70 to worst post-baseline: 70
    2
    0
    1
        Baseline: 70 to worst post-baseline: 80
    0
    0
    0
        Baseline: 70 to worst post-baseline: 90
    0
    0
    0
        Baseline: 70 to worst post-baseline: 100
    0
    0
    0
        Baseline: 80 to worst post-baseline: 50
    0
    0
    0
        Baseline: 80 to worst post-baseline: 60
    1
    0
    0
        Baseline: 80 to worst post-baseline: 70
    1
    1
    0
        Baseline: 80 to worst post-baseline: 80
    0
    2
    1
        Baseline: 80 to worst post-baseline: 90
    0
    0
    0
        Baseline: 80 to worst post-baseline: 100
    0
    0
    0
        Baseline: 90 to worst post-baseline: 50
    0
    0
    0
        Baseline: 90 to worst post-baseline: 60
    0
    0
    1
        Baseline: 90 to worst post-baseline: 70
    0
    0
    0
        Baseline: 90 to worst post-baseline: 80
    1
    0
    1
        Baseline: 90 to worst post-baseline: 90
    0
    2
    0
        Baseline: 90 to worst post-baseline: 100
    0
    0
    0
        Baseline: 100 to worst post-baseline: 50
    0
    0
    0
        Baseline: 100 to worst post-baseline: 60
    0
    0
    0
        Baseline:100 to worst post-baseline: 70
    1
    1
    0
        Baseline: 100 to worst post-baseline: 80
    0
    0
    0
        Baseline: 100 to worst post-baseline: 90
    0
    0
    0
        Baseline: 100 to worst post-baseline: 100
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Shift From Baseline to Worst Post-baseline for Karnofsky Performance Status Scores

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    End point title
    		 Number of Subjects With Shift From Baseline to Worst Post-baseline for Karnofsky Performance Status Scores
    End point description
    Scale assessed as best/worst score change from baseline by functional impairment.Score ranges:0-100, lower score worst survival for most serious illnesses.100=normal;no complaints;no evidence of disease;90=able to carry on normal activity with effort,minor sign or symptoms of disease;80=normal activity with effort;some sign/symptoms of disease;70=cares for self;unable to carry on normal activity/do active work;60=requires occasional assistance,but is able to care for most personal needs;50=requires considerable assistance, frequent medical care;40=disabled; requires special care, assistance;30=severely disabled; hospitalization indicated, although death is not imminent;20=very sick;hospitalization;10=moribund;fatal processes progressively worsening;0=dead.The SAS included all subjects who receive at least 1 dose of study drug.“N”=subjects evaluable for OM with non-missing data at baseline; any post-baseline timepoint. Data for secondary endpoint was collected and analyzed up to PCD.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 32 months
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    1
    0 [2]
    1
    Units: subjects
        Baseline score 70 to worst post-baseline score 50
    0
    0
        Baseline score 70 to worst post-baseline score 60
    0
    0
        Baseline score 70 to worst post-baseline score 70
    1
    0
        Baseline score 70 to worst post-baseline score 80
    0
    0
        Baseline score 70 to worst post-baseline score 90
    0
    0
        Baseline score 90 to worst post-baseline score 50
    0
    0
        Baseline score 90 to worst post-baseline score 60
    0
    0
        Baseline score 90 to worst post-baseline score 70
    0
    0
        Baseline score 90 to worst post-baseline score 80
    0
    1
        Baseline score 90 to worst post-baseline score 90
    0
    0
        Baseline score 90 to worst post-baseline score 100
    0
    0
    Notes
    [2] - "n" signifies non-missing data at both baseline and any post-baseline.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined as the time from the first date of documented PR or CR to the date of disease progression or date of death (whichever occurred first). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The FAS included all subjects who receive at least 1 dose of study drug. Here overall number analyzed “N” are the subjects who were evaluable for the OM however no subjects with best overall response of complete response or partial response were observed here. As planned, data for this secondary endpoint was collected and analyzed up to the PCD.
    End point type
    Secondary
    End point timeframe
    From day of first documentation of PR or CR to the day of disease progression or death (up to approximately 32 months)
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [3] - No subjects with best overall response of complete response or partial response were observed here.
    [4] - No subjects with best overall response of complete response or partial response were observed here.
    [5] - No subjects with best overall response of complete response or partial response were observed here.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from the first dose date to the date of death. The FAS included all subjects who receive at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From the day of first dose to the day of death, up to approximately 44 months
    End point values
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: NRSTS Eribulin mesylate 1.4 mg/m^2: EWS
    Number of subjects analysed
    8
    8
    5
    Units: months
        median (confidence interval 95%)
    5.08 (1.74 to 6.47)
    6.95 (0.72 to 16.26)
    7.89 (2.50 to 29.80)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 44 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: RMS
    Reporting group description
    		 Pediatric subjects with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: EWS
    Reporting group description
    		 Pediatric subjects with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. Subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Reporting group title
    Eribulin mesylate 1.4 mg/m^2: NRSTS
    Reporting group description
    		 Pediatric subjects with NRSTS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m^2. subjects continued to receive study therapy until progression of disease, (per RECIST v.1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.

    Serious adverse events
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: EWS Eribulin mesylate 1.4 mg/m^2: NRSTS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    3 / 5 (60.00%)
    2 / 8 (25.00%)
         number of deaths (all causes)
    8
    5
    7
         number of deaths resulting from adverse events
    1
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Malignant pleural effusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac tamponade
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neuralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 5 (20.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Mouth haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (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
    Costochondritis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (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
    Muscular weakness
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Eribulin mesylate 1.4 mg/m^2: RMS Eribulin mesylate 1.4 mg/m^2: EWS Eribulin mesylate 1.4 mg/m^2: NRSTS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    5 / 5 (100.00%)
    8 / 8 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Tumour pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotension
         subjects affected / exposed
    4 / 8 (50.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    5
    1
    0
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    Fatigue
         subjects affected / exposed
    4 / 8 (50.00%)
    1 / 5 (20.00%)
    4 / 8 (50.00%)
         occurrences all number
    8
    1
    4
    Influenza like illness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    3 / 8 (37.50%)
    2 / 5 (40.00%)
    3 / 8 (37.50%)
         occurrences all number
    4
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    2
    0
    3
    Dyspnoea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Pleural effusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Productive cough
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Tracheal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Depression
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 8 (62.50%)
    2 / 5 (40.00%)
    2 / 8 (25.00%)
         occurrences all number
    9
    2
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 8 (75.00%)
    3 / 5 (60.00%)
    1 / 8 (12.50%)
         occurrences all number
    12
    4
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    3
    0
    3
    Blood bilirubin increased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 5 (20.00%)
    1 / 8 (12.50%)
         occurrences all number
    4
    1
    2
    Blood creatinine increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    3 / 8 (37.50%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    3 / 8 (37.50%)
    2 / 5 (40.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    3
    1
    International normalised ratio increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    7 / 8 (87.50%)
    4 / 5 (80.00%)
    4 / 8 (50.00%)
         occurrences all number
    13
    26
    11
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 8 (37.50%)
    3 / 5 (60.00%)
    4 / 8 (50.00%)
         occurrences all number
    9
    13
    5
    Lymphocyte count increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 5 (40.00%)
    1 / 8 (12.50%)
         occurrences all number
    4
    3
    2
    Protein urine present
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    4
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    6 / 8 (75.00%)
    3 / 5 (60.00%)
    4 / 8 (50.00%)
         occurrences all number
    16
    23
    12
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Mitral valve disease
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary valve disease
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    1
    Tricuspid valve disease
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    10
    0
    2
    Lethargy
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    Paraesthesia
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    1
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 8 (62.50%)
    4 / 5 (80.00%)
    5 / 8 (62.50%)
         occurrences all number
    24
    16
    7
    Leukopenia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    0
    0
    6
    Thrombocytopenia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 5 (20.00%)
    2 / 8 (25.00%)
         occurrences all number
    1
    1
    2
    Diarrhoea
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    0
    2
    Nausea
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 5 (20.00%)
    2 / 8 (25.00%)
         occurrences all number
    3
    1
    2
    Stomatitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    2
    Vomiting
         subjects affected / exposed
    3 / 8 (37.50%)
    1 / 5 (20.00%)
    1 / 8 (12.50%)
         occurrences all number
    7
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 8 (37.50%)
    0 / 5 (0.00%)
    4 / 8 (50.00%)
         occurrences all number
    3
    0
    4
    Night sweats
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    0
    Proteinuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Back pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    2
    Muscle spasms
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    3 / 8 (37.50%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 5 (40.00%)
    2 / 8 (25.00%)
         occurrences all number
    3
    3
    3
    Pain in jaw
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Catheter site infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 5 (20.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Alkalosis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 5 (40.00%)
    3 / 8 (37.50%)
         occurrences all number
    2
    2
    3
    Dehydration
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    4 / 8 (50.00%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    12
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    1
    0
    Hypermagnesaemia
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 5 (20.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    1
    Hypernatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 5 (40.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    5
    0
    Hypoalbuminaemia
         subjects affected / exposed
    4 / 8 (50.00%)
    2 / 5 (40.00%)
    1 / 8 (12.50%)
         occurrences all number
    10
    4
    1
    Hypocalcaemia
         subjects affected / exposed
    3 / 8 (37.50%)
    1 / 5 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    6
    3
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 8 (37.50%)
    2 / 5 (40.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    2
    0
    Hyponatraemia
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 5 (40.00%)
    3 / 8 (37.50%)
         occurrences all number
    3
    3
    3
    Hypophosphataemia
         subjects affected / exposed
    3 / 8 (37.50%)
    1 / 5 (20.00%)
    1 / 8 (12.50%)
         occurrences all number
    5
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2017
    Inclusion Criterion was updated in line with the label for Halaven® regarding definition of impaired renal function. Exclusion Criterion was updated in line with the label for Halaven, regarding the concomitant use of drugs that prolong the QTc. (Eribulin mesylate, Instructions for QTc Prolongation on Electrocardiogram [ECG]) was updated in line with the Halaven label. The text regarding pregnancy testing was amended to clarify that serum beta-human chorionic gonadotropin or urine test is required within 72 hours of first dose of study drug and to align Exclusion Criterion and Schedule of Procedures/Assessments.
    29 Sep 2017
    In view of the subject population, CNS imaging was only to be required for subjects with a history of protocol-eligible brain metastasis and as clinically indicated. The text was updated for clarification purposes. Assessment grade added for NRSTS for clarification. Time of full neurological examination and assessment criteria used were modified for clarification. Instructions for prior antibody therapy were updated in line with eribulin study protocols. Clarification that for sites outside the EU, double barrier method of contraception is acceptable for those subjects that are not on a stable dose of hormonal contraception. The text was updated for clarification purposes; responses confirmed 4 weeks post initial assessment of PR/CR per RECIST v.1.1 were to be used in the analysis.
    20 Dec 2018
    Two exploratory objectives of DOR and OS were changed to secondary objectives, endpoints and analyses following feedback from the FDA and the European Medicines Agency Paediatric Committee (EMA PDCO). Inclusion Criterion was corrected. Exclusion Criterion was updated to be in line with eribulin study protocols. The screening period was extended from 14 to 28 days, following feedback from investigators, to allow more time for completion of screening procedures and to prevent unnecessary repeat scans. Following feedback from the EMA PDCO, the duration of follow-up was clarified and increased. Magnesium was added to the chemistry panel for clinical laboratory tests in line with eribulin study protocols.

    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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