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    Clinical Trial Results:
    A phase II randomized – non comparative – study on the activity of trabectedin or gemcitabine + docetaxel in metastatic or locally relapsed uterine leiomyosarcoma pretreated with conventional chemotherapy.

    Summary
    EudraCT number
    		 2009-016017-24
    Trial protocol
    		 IT  
    Global end of trial date
    30 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2022
    First version publication date
    22 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2009-016017-24
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02249702
    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, 20156
    Public contact
    Eliana Rulli, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, 039 0239014645, eliana.rulli@marionegri.it
    Scientific contact
    Eliana Rulli, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, 039 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
    11 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective will be to assess the clinical benefit rate (defined as 6-month progression free rate) with T in patients with locally relapsed/metastatic uterine leiomyosarcoma pretreated with anthracycline ± ifosfamide and/or gemcitabine ± docetaxel. For the subgroup population pretreated only with anthracycline ± ifosfamide the patients enrolled in the arm B will serve as a parallel internal control.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2010
    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: 168
    Worldwide total number of subjects
    168
    EEA total number of subjects
    168
    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)
    137
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 To be eligible for the trial patients must have received at least one line of chemotherapy either in adjuvant setting or as first line chemotherapy in advanced/recurrent disease. Patients who have not already received gemcitabine ± docetaxel will be randomized to receive trabectedin (arm A) or gemcitabine+docetaxel (arm B).

    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
    		 Trabectedin (Arm A randomized)
    Arm description
    		 Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trabectedin is manufactured by PharmaMar as a lyophilized powder in glass vials containing 0.25 or 1 mg of the drug. It has to be reconstituted in 5 ml or 20 ml of sterile water for injection and further diluted in sodium chloride solution 0.9% for a total volume of 500 ml and administered at the dose of 1.3 mg/sqm as a 24-hour continuous infusion via a central venous access. All patients must have an indwelling central catheter at the time of starting trabectedin.

    Arm title
    		 Gemcitabine+Docetaxel (Arm B)
    Arm description
    		 Gemcitabine+docetaxel treatment is planned for six cycles, unless there is evidence of disease progression, unacceptable toxicity or patient's intolerance or unwillingness to continue treatment, or medical decision by the responsible physician. Patients with continued response after six cycles can receive two additional cycles of combination therapy or continue with Gemcitabine alone.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gemcitabine+Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 min, followed by docetaxel 75 mg/m2 on day 8 intravenously over 1 h.

    Arm title
    		 Trabectedin (Arm A)
    Arm description
    		 Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trabectedin is manufactured by PharmaMar as a lyophilized powder in glass vials containing 0.25 or 1 mg of the drug. It has to be reconstituted in 5 ml or 20 ml of sterile water for injection and further diluted in sodium chloride solution 0.9% for a total volume of 500 ml and administered at the dose of 1.3 mg/sqm as a 24-hour continuous infusion via a central venous access. All patients must have an indwelling central catheter at the time of starting trabectedin.

    Number of subjects in period 1
    		Trabectedin (Arm A randomized) Gemcitabine+Docetaxel (Arm B) Trabectedin (Arm A)
    Started
    45
    42
    81
    Completed
    45
    42
    81

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 168 168
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 137 137
        From 65-84 years
    		 31 31
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 56.2 (49.4 to 63.1) -
    Gender categorical
    Units: Subjects
        Female
    		 168 168
    Subject analysis sets

    Subject analysis set title
    Safety set A
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population includes all subjects who provided informed consent and were assigned to trabectedin arm, who had no major violations of eligibility criteria, and who received at least one dose of treatment.

    Subject analysis set title
    Safety set B
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population includes all subjects who provided informed consent and were assigned to trabectedin arm, who had no major violations of eligibility criteria, and who received at least one dose of treatment.

    Subject analysis set title
    PP set A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population includes all subjects who provided informed consent and were assigned to trabectedin arm, without major violations of eligibility criteria, who have received at least two cycles of treatment.

    Subject analysis set title
    PP set B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population includes all subjects who provided informed consent and were assigned to trabectedin arm, without major violations of eligibility criteria, who have received at least two cycles of treatment.

    Subject analysis set title
    Safety set A (randomized)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population includes all subjects who provided informed consent and were randomized to one of the treatment arms, who had no major violations of eligibility criteria, and who received at least one dose of treatment.

    Subject analysis set title
    PP set A (randomized)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population includes all subjects who provided informed consent and were randomized to one of the treatment arms, without major violations of eligibility criteria, who have received at least two cycle of the treatment assigned.

    Subject analysis sets values
    		 Safety set A Safety set B PP set A PP set B Safety set A (randomized) PP set A (randomized)
    Number of subjects
    123
    39
    115
    38
    43
    39
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    100
    34
    94
    33
        From 65-84 years
    23
    5
    21
    5
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    56.6 (50.5 to 63.4)
    54.1 (45.4 to 61.9)
    56.6 (50.4 to 63.2)
    54.7 (45.4 to 61.9)
    Gender categorical
    Units: Subjects
        Female
    123
    39
    115
    38

    End points

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    End points reporting groups
    Reporting group title
    Trabectedin (Arm A randomized)
    Reporting group description
    		 Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician.

    Reporting group title
    Gemcitabine+Docetaxel (Arm B)
    Reporting group description
    		 Gemcitabine+docetaxel treatment is planned for six cycles, unless there is evidence of disease progression, unacceptable toxicity or patient's intolerance or unwillingness to continue treatment, or medical decision by the responsible physician. Patients with continued response after six cycles can receive two additional cycles of combination therapy or continue with Gemcitabine alone.

    Reporting group title
    Trabectedin (Arm A)
    Reporting group description
    		 Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician.

    Subject analysis set title
    Safety set A
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population includes all subjects who provided informed consent and were assigned to trabectedin arm, who had no major violations of eligibility criteria, and who received at least one dose of treatment.

    Subject analysis set title
    Safety set B
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population includes all subjects who provided informed consent and were assigned to trabectedin arm, who had no major violations of eligibility criteria, and who received at least one dose of treatment.

    Subject analysis set title
    PP set A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population includes all subjects who provided informed consent and were assigned to trabectedin arm, without major violations of eligibility criteria, who have received at least two cycles of treatment.

    Subject analysis set title
    PP set B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population includes all subjects who provided informed consent and were assigned to trabectedin arm, without major violations of eligibility criteria, who have received at least two cycles of treatment.

    Subject analysis set title
    Safety set A (randomized)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population includes all subjects who provided informed consent and were randomized to one of the treatment arms, who had no major violations of eligibility criteria, and who received at least one dose of treatment.

    Subject analysis set title
    PP set A (randomized)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population includes all subjects who provided informed consent and were randomized to one of the treatment arms, without major violations of eligibility criteria, who have received at least two cycle of the treatment assigned.

    Primary: PFS-6 (Arm A)

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    End point title
    		 PFS-6 (Arm A) [1]
    End point description
    PFS-6 was defined as the percentage of patients included in the PP population who were alive and progression free at 6 months after randomization.
    End point type
    Primary
    End point timeframe
    6 months
    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: Since the trail was non-comparative, no statistical comparison between arms was planned and performed
    End point values
    		 Trabectedin (Arm A) PP set A
    Number of subjects analysed
    81
    108
    Units: patients
    38
    38
    Statistical analysis title
    		 Progression Free Survival at 6 months (Arm A)
    Comparison groups
    Trabectedin (Arm A) v PP set A
    Number of subjects included in analysis
    189
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    Method
    Parameter type
    		 Proportion of responder
    Point estimate
    35.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 26.2
         upper limit
    		 45
    Notes
    [2] - Since the trail was non-comparative, no statistical comparison between arms was planned and performed

    Primary: PFS-6 (Arm B)

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    End point title
    		 PFS-6 (Arm B) [3]
    End point description
    PFS-6 was defined as the percentage of patients included in the PP population who were alive and progression free at 6 months after randomization.
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [3] - 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: Since the trail was non-comparative, no statistical comparison between arms was planned and performed
    End point values
    		 Gemcitabine+Docetaxel (Arm B) PP set B
    Number of subjects analysed
    33
    33
    Units: patients
    17
    17
    Statistical analysis title
    		 Progression Free Survival at 6 months (Arm B)
    Comparison groups
    Gemcitabine+Docetaxel (Arm B) v PP set B
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Proportion of responder
    Point estimate
    51.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.5
         upper limit
    		 69.2

    Primary: PFS-6 (Arm A randomized)

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    End point title
    		 PFS-6 (Arm A randomized) [4]
    End point description
    PFS-6 was defined as the percentage of patients included in the PP population who were alive and progression free at 6 months after randomization.
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [4] - 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: Since the trail was non-comparative, no statistical comparison between arms was planned and performed
    End point values
    		 Trabectedin (Arm A randomized) PP set A (randomized)
    Number of subjects analysed
    38
    38
    Units: patients
    13
    13
    Statistical analysis title
    		 Progression Free Survival at 6 months (Arm A rand)
    Comparison groups
    Trabectedin (Arm A randomized) v PP set A (randomized)
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Proportion of responder
    Point estimate
    34.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.6
         upper limit
    		 51.4

    Secondary: PFS (Arm A)

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    End point title
    		 PFS (Arm A) [5]
    End point description
    PFS was defined as the time from the date of randomization/registration to the date of first progression or death from any cause, whichever comes first.
    End point type
    Secondary
    End point timeframe
    From randomization/registration
    Notes
    [5] - 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: Since the trail was non-comparative, no statistical comparison between arms was planned and performed
    End point values
    		 Trabectedin (Arm A) PP set A
    Number of subjects analysed
    81
    115
    Units: months
        median (inter-quartile range (Q1-Q3))
    4.1 (1.9 to 10.7)
    4.1 (1.9 to 10.7)
    Statistical analysis title
    		 Progression Free Survival (Arm A)
    Comparison groups
    Trabectedin (Arm A) v PP set A
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    Parameter type
    		 Median PFS
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 5.7
    Notes
    [6] - Since the trail was non-comparative, no statistical comparison between arms was planned and performed

    Secondary: PFS (Arm A randomized)

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    End point title
    		 PFS (Arm A randomized) [7]
    End point description
    PFS was defined as the time from the date of randomization/registration to the date of first progression or death from any cause, whichever comes first.
    End point type
    Secondary
    End point timeframe
    From the date of randomization/registration
    Notes
    [7] - 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: Since the trail was non-comparative, no statistical comparison between arms was planned and performed
    End point values
    		 Trabectedin (Arm A randomized) PP set A (randomized)
    Number of subjects analysed
    39
    39
    Units: months
        median (inter-quartile range (Q1-Q3))
    3.5 (1.7 to 8.6)
    3.5 (1.7 to 8.6)
    Statistical analysis title
    		 Progression Free Survival (Arm A randomized)
    Comparison groups
    Trabectedin (Arm A randomized) v PP set A (randomized)
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median PFS
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 7

    Secondary: PFS (Arm B)

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    End point title
    		 PFS (Arm B) [8]
    End point description
    PFS was defined as the time from the date of randomization/registration to the date of first progression or death from any cause, whichever comes first.
    End point type
    Secondary
    End point timeframe
    From the date of randomization/registration
    Notes
    [8] - 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: Since the trail was non-comparative, no statistical comparison between arms was planned and performed
    End point values
    		 Gemcitabine+Docetaxel (Arm B) PP set B
    Number of subjects analysed
    38
    38
    Units: months
        median (inter-quartile range (Q1-Q3))
    6.9 (2.4 to 15.4)
    6.9 (2.4 to 15.4)
    Statistical analysis title
    		 Progression Free Survival (Arm B)
    Comparison groups
    Gemcitabine+Docetaxel (Arm B) v PP set B
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median PFS
    Point estimate
    6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.6
         upper limit
    		 14.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Trabectedin (Arm A randomized)
    Reporting group description
    		 Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician.

    Reporting group title
    Gemcitabine+Docetaxel (Arm B)
    Reporting group description
    		 Gemcitabine+docetaxel treatment is planned for six cycles, unless there is evidence of disease progression, unacceptable toxicity or patient's intolerance or unwillingness to continue treatment, or medical decision by the responsible physician. Patients with continued response after six cycles can receive two additional cycles of combination therapy or continue with Gemcitabine alone.

    Reporting group title
    Trabectedin (Arm A)
    Reporting group description
    		 Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician.

    Serious adverse events
    		 Trabectedin (Arm A randomized) Gemcitabine+Docetaxel (Arm B) Trabectedin (Arm A)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 45 (57.78%)
    26 / 42 (61.90%)
    0 / 126 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Pulmonary thrombosis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (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
    Pulmonary embolism
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (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
    Deep vein thrombosis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (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
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 42 (4.76%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 126 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary infarction
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (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
    Dyspnoea
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alkaline
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injection site reaction
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 42 (4.76%)
    0 / 126 (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
    Anaemia
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (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
    Abdominal pain
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 42 (4.76%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal perforation
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 126 (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
    Renal failure
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (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
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 126 (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
    Infections and infestations
    Infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 126 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Trabectedin (Arm A randomized) Gemcitabine+Docetaxel (Arm B) Trabectedin (Arm A)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 45 (100.00%)
    42 / 42 (100.00%)
    126 / 126 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 45 (15.56%)
    12 / 42 (28.57%)
    29 / 126 (23.02%)
         occurrences all number
    27
    23
    100
    Myalgia
         subjects affected / exposed
    7 / 45 (15.56%)
    7 / 42 (16.67%)
    12 / 126 (9.52%)
         occurrences all number
    33
    16
    86
    Blood and lymphatic system disorders
    ALT increased
         subjects affected / exposed
    11 / 45 (24.44%)
    5 / 42 (11.90%)
    16 / 126 (12.70%)
         occurrences all number
    54
    16
    44
    Haemoglobin
         subjects affected / exposed
    19 / 45 (42.22%)
    31 / 42 (73.81%)
    24 / 126 (19.05%)
         occurrences all number
    71
    103
    73
    Leucocytes/WBC
         subjects affected / exposed
    22 / 45 (48.89%)
    20 / 42 (47.62%)
    26 / 126 (20.63%)
         occurrences all number
    55
    53
    73
    Neutrophils/granulocytes
         subjects affected / exposed
    25 / 45 (55.56%)
    21 / 42 (50.00%)
    27 / 126 (21.43%)
         occurrences all number
    57
    51
    72
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    12 / 45 (26.67%)
    12 / 42 (28.57%)
    32 / 126 (25.40%)
         occurrences all number
    19
    21
    75

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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.
    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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