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    Clinical Trial Results:
    A PHASE II STUDY ON THE ACTIVITY OF TRABECTEDIN IN PRETREATED EPITHELIOID OR BIPHASIC/SARCOMATOID MALIGNANT PLEURAL MESOTHELIOMA (MPM) ATREUS TRIAL

    Summary
    EudraCT number
    		 2011-006330-16
    Trial protocol
    		 IT  
    Global end of trial date
    09 Dec 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    IRFMN-MPM-6077
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02194231
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Istituto di Ricerche Farmacologiche Mario Negri IRCCS
    Sponsor organisation address
    Via Mario Negri 2, Milan, Italy,
    Public contact
    Eliana Rulli, Istituto di Ricerche Farmacologiche Mario Negri IRCCS , 39 0239014645, eliana.rulli@marionegri.it
    Scientific contact
    Eliana Rulli, Istituto di Ricerche Farmacologiche Mario Negri IRCCS , 39 0239014645, eliana.rulli@marionegri.it
    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
    24 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a phase II, single arm, multicentre study. The primary objective of the study is to assess the activity of trabectedin in patients with epithelioid MPM relapsing after treatment with pemetrexed plus platinum-based drugs.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2013
    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
    Italy: 145
    Worldwide total number of subjects
    145
    EEA total number of subjects
    145
    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)
    55
    From 65 to 84 years
    90
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 145 patients were enrolled in seven sites in Italy: 78 patients (53.8%) with epithelioid MPM and 67 (46.2%) with biphasic or sarcomatoid MPM.

    Pre-assignment
    Screening details
    		 NA

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 epithelioid MPM (A)
    Arm description
    		 Recruited patients will receive 1.1 mg/m2 intravenous trabectedin infusion over 3 hours every 21 days until disease progression or development of side-effects requiring treatment discontinuation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.1 mg/mq over 3 hours infusion every 21 days

    Arm title
    		 biphasic/sarcomatoid MPM (B)
    Arm description
    		 Recruited patients will receive 1.1 mg/m2 intravenous trabectedin infusion over 3 hours every 21 days until disease progression or development of side-effects requiring treatment discontinuation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.1 mg/mq over 3 hours infusion every 21 days

    Number of subjects in period 1
    		epithelioid MPM (A) biphasic/sarcomatoid MPM (B)
    Started
    78
    67
    Completed
    66
    54
    Not completed
    12
    13
         Treatment not started
    2
    4
         Protocol major violations
    3
    4
         Treatment discontinuation
    7
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    epithelioid MPM (A)
    Reporting group description
    		 Recruited patients will receive 1.1 mg/m2 intravenous trabectedin infusion over 3 hours every 21 days until disease progression or development of side-effects requiring treatment discontinuation.

    Reporting group title
    biphasic/sarcomatoid MPM (B)
    Reporting group description
    		 Recruited patients will receive 1.1 mg/m2 intravenous trabectedin infusion over 3 hours every 21 days until disease progression or development of side-effects requiring treatment discontinuation.

    Reporting group values
    		 epithelioid MPM (A) biphasic/sarcomatoid MPM (B) Total
    Number of subjects
    		 78 67 145
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 33 22 55
        From 65-84 years
    		 45 45 90
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 66.4 (62 to 72) 67.9 (63 to 74.4) -
    Gender categorical
    Units: Subjects
        Female
    		 22 15 37
        Male
    		 56 52 108
    Subject analysis sets

    Subject analysis set title
    ITT set A
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set A includes all subjects with epithelioid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria.

    Subject analysis set title
    ITT set B
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set B includes all subjects with biphasic or sarcomatoid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria.

    Subject analysis set title
    Safety set A
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set A includes all subjects with epithelioid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least one dose of study treatment and had at least one safety follow-up, whether withdrawn prematurely or not.

    Subject analysis set title
    Safety set B
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set B includes all subjects with biphasic or sarcomatoid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least one dose of study treatment and had at least one safety follow-up, whether withdrawn prematurely or not.

    Subject analysis set title
    PP set A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set A includes all subjects with epithelioid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least 12 weeks of treatment or who interrupted treatment before 12 weeks for progressive disease or death, and whose disease was assessed.

    Subject analysis set title
    PP set B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set B includes all subjects with biphasic or sarcomatoid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least 12 weeks of treatment or who interrupted treatment before 12 weeks for progressive disease or death, and whose disease is assessed.

    Subject analysis sets values
    		 ITT set A ITT set B Safety set A Safety set B PP set A PP set B
    Number of subjects
    75
    63
    73
    59
    66
    54
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    33
    22
    31
    19
    29
    14
        From 65-84 years
    45
    45
    42
    40
    37
    40
        85 years and over
    0
    0
    0
    0
    0
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    66.3 (61.3 to 72.0)
    67.9 (63.0 to 74.4)
    66.3 (61 to 72)
    67.9 (63 to 74.6)
    65.9 (60.3 to 71.9)
    68.3 (64.2 to 74.6)
    Gender categorical
    Units: Subjects
        Female
    22
    15
    22
    13
    21
    12
        Male
    53
    48
    51
    46
    45
    42

    End points

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    End points reporting groups
    Reporting group title
    epithelioid MPM (A)
    Reporting group description
    		 Recruited patients will receive 1.1 mg/m2 intravenous trabectedin infusion over 3 hours every 21 days until disease progression or development of side-effects requiring treatment discontinuation.

    Reporting group title
    biphasic/sarcomatoid MPM (B)
    Reporting group description
    		 Recruited patients will receive 1.1 mg/m2 intravenous trabectedin infusion over 3 hours every 21 days until disease progression or development of side-effects requiring treatment discontinuation.

    Subject analysis set title
    ITT set A
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set A includes all subjects with epithelioid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria.

    Subject analysis set title
    ITT set B
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set B includes all subjects with biphasic or sarcomatoid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria.

    Subject analysis set title
    Safety set A
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set A includes all subjects with epithelioid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least one dose of study treatment and had at least one safety follow-up, whether withdrawn prematurely or not.

    Subject analysis set title
    Safety set B
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set B includes all subjects with biphasic or sarcomatoid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least one dose of study treatment and had at least one safety follow-up, whether withdrawn prematurely or not.

    Subject analysis set title
    PP set A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set A includes all subjects with epithelioid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least 12 weeks of treatment or who interrupted treatment before 12 weeks for progressive disease or death, and whose disease was assessed.

    Subject analysis set title
    PP set B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set B includes all subjects with biphasic or sarcomatoid MPM who provided informed consent and were enrolled in the study, with no major violations of the eligibility criteria, who received at least 12 weeks of treatment or who interrupted treatment before 12 weeks for progressive disease or death, and whose disease is assessed.

    Primary: PFS

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    End point title
    		 PFS [1]
    End point description
    PFS12w is <25%, and at the same time reveal, at a β level of 15%, whether PFS12w is >40%. The PFS12w and response rate will be reported descriptively as counts, percents and using 80% and 95% confidence intervals for the epithelioid cohort.
    End point type
    Primary
    End point timeframe
    PFS12w - Patients alive and free of progression at 12 weeks
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are reported by arm
    End point values
    		 epithelioid MPM (A) PP set A
    Number of subjects analysed
    62
    62
    Units: patients
    27
    27
    Statistical analysis title
    		 PFS rate 12weeks
    Statistical analysis description
    Patients who interrupted trt for progressive disease or death before 12 weeks were included in the analysis as failures. Patients who did not progress or die within 12 weeks from trt start and without a disease evaluation between the 11th and the 13th week were considered as not evaluable, unless the absence of disease progression was confirmed in the disease evaluations after the 13th week. The 80% and 95% confidence intervals (CI) for PFS12w were computed by means of exact binomial methods
    Comparison groups
    epithelioid MPM (A) v PP set A
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 PFS12w
    Point estimate
    43.5
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 34.9
         upper limit
    		 52.5

    Primary: PFS

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    End point title
    		 PFS [2]
    End point description
    With a one-sided α level of 5%, the null hypothesis that PFS12w is <15% and to have 95% power to reveal whether PFS12w is >35%. The PFS12w and response rate will be reported descriptively as counts, percents and using 90% and 95% confidence intervals for the biphasic/sarcomatoid cohort.
    End point type
    Primary
    End point timeframe
    PFS12w - Patients alive and free of progression at 12 weeks
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are reported by arm
    End point values
    		 biphasic/sarcomatoid MPM (B) PP set B
    Number of subjects analysed
    52
    52
    Units: patients
    16
    16
    Statistical analysis title
    		 PFS rate 12weeks
    Statistical analysis description
    Patients who interrupted trt for progressive disease or death before 12 weeks were included in the analysis as failures. Patients who did not progress or die within 12 weeks from trt start and without a disease evaluation between the 11th and the 13th week were considered as not evaluable, unless the absence of disease progression was confirmed in the disease evaluations after the 13th week. The 80% and 95% confidence intervals (CI) for PFS12w were computed by means of exact binomial methods.
    Comparison groups
    biphasic/sarcomatoid MPM (B) v PP set B
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 PFS12w
    Point estimate
    30.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 20.3
         upper limit
    		 42.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 145 (31.72%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pericardial effusion
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema (cardiogenic)
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 145 (2.07%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Multi-organ failure
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Pyrexia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Oesophageal achalasia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Orchitis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnea
         subjects affected / exposed
    7 / 145 (4.83%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    4 / 145 (2.76%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    Pneumothorax
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Sternal fracture
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 145 (3.45%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 2
    Sepsis
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Septic shock
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    137 / 145 (94.48%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    106 / 145 (73.10%)
         occurrences all number
    576
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    93 / 145 (64.14%)
         occurrences all number
    251
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    133 / 145 (91.72%)
         occurrences all number
    755
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    49 / 145 (33.79%)
         occurrences all number
    148

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2014
    PRINCIPAL CHANGES: 1.OBJECTIVES -> adding a secondary objective 2.ENDOPINTS -> adding a secondary outcome 3.CENTERS -> adding a clinical centre 4.INCLUSION CRITERIA -> changes in inclusion criteria 5.STUDY PROCEDURE -> changes in study procedures (Hematological evaluation added) 6.PREMEDICATION AND CONCOMITANT THERAPIES -> changes in study procedures and concomitant therapies 7.PAIN EVALUATION -> changes in study procedures, its scientific relevance, in data collection 8.STATISTICAL ANALYSIS -> changes in primary and secondary statistical analysis 9.BLOOD MACROPHAGES ANALYSIS -> changes in study procedures and CRF 10.TRANSLATIONAL STUDY PROCEDURES -> changes in study procedures and CRF
    27 Oct 2015
    PRINCIPAL CHANGES: 1.SAMPLE SIZE -> changes in sample size calculation 2.STUDY PROCEDURE -> changes regarding the length of the study 3.PRIMARY ENDPOINT -> definition of the timing for TAC evaluation 4.TAC EVALUATION -> changes in TAC evaluation according to the modified RECIST criteria 5.TRABECTEDINE -> Trabectedine dose reduction 6.CENTERS -> adding clinical centres
    16 Nov 2016
    PRINCIPAL CHANGES: 1.TAC EVALUATION -> adding a TAC centralized review 2.ECG -> exam modified in the study 3.STATISTICAL ANALYSIS -> more details about sample size and statistical analysis of the translational study 4.INFORMED CONSENT -> update of the document

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32732073
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