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    Clinical Trial Results:
    Phase II Clinical Trial of Pazopanib to evaluate the activity and tolerability in patients with advanced and/or metastatic liposarcoma who have relapsed following standard therapies or for whom no standard therapy exists

    Summary
    EudraCT number
    2012-002745-38
    Trial protocol
    ES   DE  
    Global end of trial date
    02 Mar 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions
    Summary report(s)
    Clinical Study Report Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    GEIS-30
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01692496
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GRUPO ESPAÑOL DE INVESTIGACIÓN EN SARCOMAS - GEIS
    Sponsor organisation address
    C/ Velázquez nº7, 3ª planta, Madrid, Spain, 28001
    Public contact
    Secretaría GEIS, GRUPO ESPAÑOL DE INVESTIGACIÓN EN SARCOMAS - GEIS, 34 934344412, investigacion@mfar.net
    Scientific contact
    Secretaría GEIS, GRUPO ESPAÑOL DE INVESTIGACIÓN EN SARCOMAS - GEIS, 34 934344412, investigacion@mfar.net
    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
    23 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the activity of Pazopanib in patients with advanced and/or metastatic liposarcoma by means of progression-free survival (PFS) assessed 12 weeks after start of treatment. (According the RECIST criteria 1.1 and central radiology review).
    Protection of trial subjects
    Subjects will receive investigational product until any of the following occur: • Subject experiences disease progression according to RECIST V 1.1 • Subject experiences unacceptable toxicities or an adverse experience that would, in the judgement of the investigator, make continued administration of the study regimen an unacceptable risk. • Subject is considered
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Jan 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
    Spain: 39
    Country: Number of subjects enrolled
    Germany: 13
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    52
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 17 eligible and treated patients will be included in each stratum. Total duration of recruitment period: 30 months.

    Pre-assignment
    Screening details
    Once a patient has signed the biological samples consent form, at least one representative formaline fixed paraffin embedded tumour block and haematoxylin/eosin slides from all the different areas of the tumor will be collected for central pathological review in order to confirm histological type of sarcoma.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Investigational arm
    Arm description
    Single arm (two cohorts) of Pazopanib 800 mg (2x400mg or 4x200 mg) given as a single agent administered once daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Pazopanib mono-hydrochloride salt
    Investigational medicinal product code
    GW786034B)
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib 800 mg (2x400mg or 4 x 200 mg) per day, once a day, should be taken orally without food at least one hour before or two hours after a meal until disease progression, the development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient, or investigator decision.

    Number of subjects in period 1
    Investigational arm
    Started
    52
    Completed
    52
    Period 2
    Period 2 title
    End of trial
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Pazopanib
    Arm description
    Single arm (two cohorts) of Pazopanib 800 mg (2x400mg or 4x200 mg) given as a single agent administered once daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Pazopanib mono-hydrochloride salt
    Investigational medicinal product code
    GW786034B)
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib 800 mg (2x400mg or 4 x 200 mg) per day, once a day, should be taken orally without food at least one hour before or two hours after a meal until disease progression, the development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient, or investigator decision.

    Number of subjects in period 2
    Pazopanib
    Started
    52
    Completed
    52

    Baseline characteristics

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

    Reporting group values
    Baseline Total
    Number of subjects
    52 52
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (standard deviation)
    58.3 ± 13.5 -
    Gender categorical
    Units: Subjects
        Female
    24 24
        Male
    28 28
    Tumour location
    Units: Subjects
        Pelvis
    1 1
        Upper extremities
    4 4
        Lower extremities
    10 10
        Retroperitoneum
    26 26
        Others
    11 11
    Histological type
    Units: Subjects
        Well-differentiated Liposarcoma
    6 6
        Well-differentiated Liposarcoma/undifferentiated
    8 8
        Undifferentiated Liposarcoma
    23 23
        Mixoid Liposarcoma
    15 15
    First treatment
    Units: Subjects
        Yes
    42 42
        No
    10 10
    Previous chemotherapy
    Units: Subjects
        Yes
    15 15
        No
    37 37

    End points

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    End points reporting groups
    Reporting group title
    Investigational arm
    Reporting group description
    Single arm (two cohorts) of Pazopanib 800 mg (2x400mg or 4x200 mg) given as a single agent administered once daily.
    Reporting group title
    Pazopanib
    Reporting group description
    Single arm (two cohorts) of Pazopanib 800 mg (2x400mg or 4x200 mg) given as a single agent administered once daily.

    Subject analysis set title
    Cohort A
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients with well-differentiated/undiferentiated lyposarcoma (ALT-WD)

    Subject analysis set title
    Cohort B
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Mixoid lyposarcoma/round cells lyposarcoma

    Primary: Progression-free survival (PFS) at 12 weeks

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    End point title
    Progression-free survival (PFS) at 12 weeks
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks after start of treatment
    End point values
    Pazopanib Cohort A Cohort B
    Number of subjects analysed
    52
    37
    15
    Units: Percentage
    54
    54
    40
    Statistical analysis title
    Comparison on PFS among cohorts
    Comparison groups
    Cohort A v Cohort B
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.05
    Method
    Logrank
    Parameter type
    Log risk ratio
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -
         upper limit
    -
    Variability estimate
    Standard deviation

    Secondary: Progression-free survival (PFS)

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    End point title
    Progression-free survival (PFS)
    End point description
    Weeks
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    Investigational arm Pazopanib Cohort A Cohort B
    Number of subjects analysed
    52
    52
    37
    52
    Units: weeks
        median (full range (min-max))
    11.86 (2.3 to 195.7)
    11.86 (2.3 to 195.7)
    15 (5.3 to 217.3)
    11.86 (2.3 to 195.7)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    Investigational arm
    Number of subjects analysed
    35
    Units: weeks
        median (full range (min-max))
    70.43 (2.3 to 217.3)
    No statistical analyses for this end point

    Secondary: Growth modulation index

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    End point title
    Growth modulation index
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    Investigational arm
    Number of subjects analysed
    52
    Units: units
        median (full range (min-max))
    0.4 (0.1 to 18.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Cohort A
    Reporting group description
    -

    Reporting group title
    Cohort B
    Reporting group description
    -

    Serious adverse events
    Cohort A Cohort B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 37 (24.32%)
    5 / 15 (33.33%)
         number of deaths (all causes)
    26
    7
         number of deaths resulting from adverse events
    2
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorder
    Additional description: Cardiac dysrhytmia and chest pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions - Other, specify
    Additional description: General status deterioration
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric hemorrhage
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Tumour budding
    Additional description: Tumour abscess
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cohort A Cohort B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 37 (75.68%)
    15 / 15 (100.00%)
    Vascular disorders
    Hypertension
    Additional description: Grade 3
         subjects affected / exposed
    5 / 37 (13.51%)
    2 / 15 (13.33%)
         occurrences all number
    5
    2
    Injury, poisoning and procedural complications
    Fracture
    Additional description: Femur, Grade 3
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
    Additional description: Grade 3
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    Aspartate aminotransferase increased
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Gamma-glutamyltransferase increased
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
    Additional description: Grade 3
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Cardiac disorders
    Chest pain
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Myocardial infarction
    Additional description: Grade 3
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anemia
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Ascites
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Fatigue
    Additional description: Also reported as Asthenia
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Malaise
    Additional description: Reported as "General Status Deterioration", grade 5
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Grade 3
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Lower gastrointestinal haemorrhage
    Additional description: Grade 5
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nausea
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Toothache
    Additional description: Grade 3
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Vomiting
    Additional description: Grade 3
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: Grade 3
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Generalized muscle weakness
    Additional description: Grade 3
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Anorexia nervosa
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Soft tissue infection
    Additional description: Abscess of tumor mass
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2013
    Modification of visits calendar to improve hepathic monitoring
    20 May 2014
    Update of safety information
    28 Dec 2016
    Update of safety information

    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.
    Further analysis in larger populations (ex. in countries were pazopanib is approved in this setting) should be considered.
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
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    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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