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    Clinical Trial Results:
    Phase II randomized clinical trial of Pazopanib alone and Pazopanib plus Gemcitabine in relapsed or metastatic soft tissue sarcoma

    Summary
    EudraCT number
    		 2009-017261-32
    Trial protocol
    		 DE  
    Global end of trial date
    10 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2025
    First version publication date
    21 Aug 2025
    Other versions
    Summary report(s)
    		 PAPAGEMO Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    KKSH077
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 AIO: AIO-STS-009, German Clinical Trials Register: DRKS00003139
    Sponsors
    Sponsor organisation name
    Martin-Luther-Universität Halle-Wittenberg
    Sponsor organisation address
    Magdeburger Str. 8, Halle (Saale), Germany, 06112
    Public contact
    Koordinierungszentrum für klinische Studien Halle/S., Koordinierungszentrum für klinische Studien Halle/S., +49 03455574903, info@kks-halle.de
    Scientific contact
    Koordinierungszentrum für klinische Studien Halle/S., Koordinierungszentrum für klinische Studien Halle/S., +49 03455574903, info@kks-halle.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this phase II trial is to assess the efficacy and toxicity of pazopanib alone or pazopanib plus gemcitabine in patients with refractory or relapsed metastatic soft tissue sarcoma (STS).
    Protection of trial subjects
    The responsible investigator will ensure that this study is conducted in agreement with either the Declaration of Helsinki (from June 1964, Tokyo October 1975, Venice October 1983, Hong Kong September 1989, Somerset West October 1996 and Edinburgh amendments from 2000) or the laws and regulations. The protocol has been written, and the study will be conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice (reference: http://www.ifpma.org/pdfifpma/e6.pdf). The protocol will be approved by Independent Ethics Committees.
    Background therapy
    		 Subjects received full supportive care during the study, including transfusion of blood and blood products, and treatment with antibiotics, analgesics, erythropoietin, or bisphosphonates, when appropriate. Due to the low emetogen potential of either Pazopanib and gemcitabine no standard antiemetic medication was recommended. In case of vomiting or emesis procedures according to institutional guidelines had to be used. In patients with diarrhoea and neutropenia, even in the absence of fever, empiric use of antibiotics as prophylaxis against bowel sepsis was to be considered. The use of a quinolone was not recommended in this setting due to the potential for QT prolongation. Haematopoietic growth factors (i.e., G- or GM-CSF) may be used according to institutional guidelines to treat febrile neutropenia, and as primary or secondary prophylaxis in case of delayed haematologic recovery during the priory cycle of treatment in Arm A. Growth factors had to be discontinued at least 48 hours prior to initiation of the next treatment of chemotherapy.
    Evidence for comparator
    		 An evidence based therapy regime cannot be recommended. New therapy options are awaited eagerly. The superior activity of pazopanib monotherapy, in the patients collective included in this trial, compared to placebo has been proven. Compared to historical data patients profit remarkable good by a pazopanib monotherpy.
    Actual start date of recruitment
    01 Jul 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    66
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between September 2011 and June 2014, the planned number of 90 patients were recruited at 14 trial sites, all of them in Germany. The last patient completed study treatment in September 2015 and study follow-up in May 2016. For the individual patient, study treatment was scheduled until progression or intolerable toxicity.

    Pre-assignment
    Screening details
    		 Patients eligable for this clinical trial will ultimately die of the disease and live expectancy in mean is short. Therefore all patients with relapsed or metastatic soft tissue sarcoma presenting at the participating trial sites with an indication for therapy were screened for selection criteria. There was no selection based on other criteria.

    Period 1
    Period 1 title
    PAPAGEMO overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pazopanib+GEM
    Arm description
    		 Pazopanib 800 mg administered orally once a day, until disease progression. Gemcitabine administered intravenously over 30min at a dose of 1000 mg/m2 (day 1, 8, repeated after 21 days), until disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Votrient
    Investigational medicinal product code
    Pazopanib
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib tablets were provided as 200 mg and 400 mg tablets, which contain pazopanib monohydrochloride salt equivalent to 200 mg and 400 mg of the free base, respectively. It was suggested to applicate 2x400 mg tablets to approach the initial dose level of 800 mg. 200 mg tablets were only be used in case of dose deescalation. Patients received pazopanib orally, 800 mg once daily until disease progression. In this study, a 3 week interval of dosing was considered as a “treatment period” or “cycle of therapy”.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Gemcitabine
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine at a dose of 1000 mg/sqm i.v. over 30min (day 1, 8, repeated after 21days), until disease progression.

    Arm title
    		 Pazopanib
    Arm description
    		 Pazopanib 800 mg administered orally once a day, until disease progression
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Votrient
    Investigational medicinal product code
    Pazopanib
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib tablets were provided as 200 mg and 400 mg tablets, which contain pazopanib monohydrochloride salt equivalent to 200 mg and 400 mg of the free base, respectively. It was suggested to applicate 2x400 mg tablets to approach the initial dose level of 800 mg. 200 mg tablets were only be used in case of dose deescalation. Patients received pazopanib orally, 800 mg once daily until disease progression. In this study, a 3 week interval of dosing was considered as a “treatment period” or “cycle of therapy”.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Gemcitabine
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine at a dose of 1000 mg/sqm i.v. over 30min (day 1, 8, repeated after 21days), until disease progression.

    Number of subjects in period 1
    		Pazopanib+GEM Pazopanib
    Started
    44
    46
    Completed
    43
    43
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    1
         Progress/relapse after one or two prior CTx
    -
    1
         Did not received one dose of study medication
    -
    1
         Failed inclusion crit.: Adequate organ fuction
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pazopanib+GEM
    Reporting group description
    		 Pazopanib 800 mg administered orally once a day, until disease progression. Gemcitabine administered intravenously over 30min at a dose of 1000 mg/m2 (day 1, 8, repeated after 21 days), until disease progression

    Reporting group title
    Pazopanib
    Reporting group description
    		 Pazopanib 800 mg administered orally once a day, until disease progression

    Reporting group values
    		 Pazopanib+GEM Pazopanib Total
    Number of subjects
    		 44 46 90
    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
    ITT n=86
    Units: years
        median (full range (min-max))
    		 57 (23 to 84) 59 (22 to 81) -
    Gender categorical
    ITT n=86
    Units: Subjects
        Female
    		 23 23 46
        Male
    		 20 20 40
        not determined
    		 1 3 4
    ECOG performance status
    ITT n=86
    Units: Subjects
        Missing
    		 2 5 7
        ECOG 0
    		 21 15 36
        ECOG 1
    		 17 24 41
        ECOG 2
    		 4 2 6
    Liposarcoma
    ITT n=86
    Units: Subjects
        No
    		 34 36 70
        Yes
    		 9 7 16
        Not determined
    		 1 3 4
    WHO histological classification at initial diagnosis
    ITT n=86
    Units: Subjects
        Angiosarcoma
    		 2 2 4
        Fibrosarcoma
    		 0 0 0
        Haemangioendothelioma
    		 0 0 0
        Leiomyosarcoma
    		 14 8 22
        Liposarcoma
    		 9 7 16
        Malignant glomus tumour
    		 0 0 0
        Malignant peripheral nerve sheath tumour
    		 1 3 4
        Malignant tenosynovial giant cell tumour
    		 0 0 0
        Malignant fibrous histiocytoma (MFH)
    		 1 1 2
        Malignant haemangiopericytoma
    		 0 0 0
        Malignant mesenchymoma
    		 1 0 1
        Malignant paraganglioma
    		 0 0 0
        Mesothelioma
    		 0 0 0
        Rhabdomyosarcoma
    		 0 3 3
        Other
    		 16 22 38
    Grading at initial diagnosis
    ITT n=86
    Units: Subjects
        Missing
    		 8 13 21
        G0
    		 0 0 0
        G1
    		 2 2 4
        G1/2
    		 1 2 3
        G2
    		 13 10 23
        G2/3
    		 2 2 4
        G3
    		 15 14 29
        G3/4
    		 2 0 2
        G4
    		 0 3 3
        GX
    		 1 0 1
    Location at initial diagnosis, Upper extremity
    Units: Subjects
        No
    		 42 39 81
        Yes
    		 1 4 5
        Not determined
    		 1 3 4
    Location at initial diagnosis, Lower extremity
    ITT n=86
    Units: Subjects
        No
    		 34 25 59
        Yes
    		 9 18 27
        Not determined
    		 1 3 4
    Location at initial diagnosis - head, face and neck
    ITT n=86
    Units: Subjects
        No
    		 41 41 82
        Yes
    		 2 2 4
        Not determined
    		 1 3 4
    Location at initial diagnosis, Thorax
    ITT n=86
    Units: Subjects
        No
    		 30 36 66
        Yes
    		 13 7 20
        Not determined
    		 1 3 4
    Location at initial diagnosis, Abdomen
    ITT n=86
    Units: Subjects
        No
    		 26 34 60
        Yes
    		 17 9 26
        Not determined
    		 1 3 4
    Location at initial diagnosis, Pelvis
    ITT n=86
    Units: Subjects
        No
    		 34 34 68
        Yes
    		 9 9 18
        Not determined
    		 1 3 4
    Clinical stage at initial diagnosis - T-status
    ITT n=86
    Units: Subjects
        T0
    		 0 1 1
        T1
    		 6 3 9
        T2
    		 20 17 37
        T3
    		 3 3 6
        T4
    		 3 0 3
        Tis/Ta
    		 0 0 0
        TX
    		 8 13 21
        Missing
    		 4 9 13
    Clinical stage at initial diagnosis - N-status
    ITT n=86
    Units: Subjects
        N0
    		 19 13 32
        N1
    		 5 1 6
        N2
    		 0 2 2
        N3
    		 0 1 1
        NX
    		 13 19 32
        Missing
    		 7 10 17
    Clinical stage at initial diagnosis - M-status
    ITT n=86
    Units: Subjects
        M0
    		 9 13 22
        M1
    		 29 18 47
        MX
    		 3 9 12
        Missing
    		 3 6 9
    Clinical stage at initial diagnosis - Stage
    ITT n=86
    Units: Subjects
        0.
    		 0 1 1
        IA
    		 1 1 2
        IB
    		 3 2 5
        IIA
    		 0 4 4
        IIB
    		 3 5 8
        IIC
    		 0 0 0
        III
    		 7 4 11
        IV
    		 26 20 46
        Missing
    		 4 9 13
    Weight
    ITT n=86
    Units: kilogram(s)
        median (full range (min-max))
    		 72.0 (49.0 to 108.0) 73.7 (46.0 to 115.0) -
    Height
    ITT n=86
    Units: cm
        median (full range (min-max))
    		 170 (152 to 195) 170 (151 to 193) -
    BMI
    ITT n=86
    Units: kg/sqm
        median (full range (min-max))
    		 24.91 (17.0 to 32.8) 24.79 (17.0 to 39.8) -
    Alanine aminotransferase (ALT)
    ITT n=86
    Units: micromole(s)/litre*s
        arithmetic mean (standard deviation)
    		 0.451 ( 0.223 ) 0.437 ( 0.298 ) -
    Aspartate aminotransferase (AST)
    ITT n=86
    Units: micromole(s)/litre*s
        arithmetic mean (standard deviation)
    		 0.434 ( 0.178 ) 0.470 ( 0.239 ) -
    Alkaline phosphatase (ALP)
    ITT n=86
    Units: micromole(s)/litre*s
        arithmetic mean (standard deviation)
    		 1.985 ( 0.969 ) 1.646 ( 0.927 ) -
    Gamma-glutamyl-transferase (GGT)
    ITT n=86
    Units: micromole(s)/litre*s
        arithmetic mean (standard deviation)
    		 1.783 ( 2.266 ) 1.222 ( 1.520 ) -
    Total bilirubin
    ITT n=86
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    		 8.4 ( 3.9 ) 8.8 ( 4.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Pazopanib+GEM
    Reporting group description
    		 Pazopanib 800 mg administered orally once a day, until disease progression. Gemcitabine administered intravenously over 30min at a dose of 1000 mg/m2 (day 1, 8, repeated after 21 days), until disease progression

    Reporting group title
    Pazopanib
    Reporting group description
    		 Pazopanib 800 mg administered orally once a day, until disease progression

    Primary: progression-free survival (PFS) 12 weeks after randomisation

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    End point title
    		 progression-free survival (PFS) 12 weeks after randomisation
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks after randomisation
    End point values
    		 Pazopanib+GEM Pazopanib
    Number of subjects analysed
    42
    43
    Units: N
    31
    20
    Statistical analysis title
    		 one-sided Cochran-Mantel-Haenszel (CMH) test
    Comparison groups
    Pazopanib+GEM v Pazopanib
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: overall survival (OS) after randomisation

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    End point title
    		 overall survival (OS) after randomisation
    End point description
    These secondary endpoints were analyzed in an exploratory manner.
    End point type
    Secondary
    End point timeframe
    from randomisation until death
    End point values
    		 Pazopanib+GEM Pazopanib
    Number of subjects analysed
    43
    43
    Units: Months
        median (confidence interval 95%)
    13.1 (7.3 to 17.9)
    11.2 (7.2 to 20.4)
    No statistical analyses for this end point

    Secondary: time to progression (TTP) after randomisation

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    End point title
    		 time to progression (TTP) after randomisation
    End point description
    These secondary endpoints were analyzed in an exploratory manner.
    End point type
    Secondary
    End point timeframe
    from randomisation until progression
    End point values
    		 Pazopanib+GEM Pazopanib
    Number of subjects analysed
    43
    43
    Units: Months
        median (confidence interval 95%)
    5.6 (4.1 to 8.5)
    2.0 (1.6 to 3.2)
    No statistical analyses for this end point

    Secondary: best overall response

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    End point title
    		 best overall response
    End point description
    best overall response was CR or PR
    End point type
    Secondary
    End point timeframe
    from randomisation until progression
    End point values
    		 Pazopanib+GEM Pazopanib
    Number of subjects analysed
    43
    43
    Units: N
        CR+PR
    5
    2
        SD+PD+death
    38
    41
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs: from the informed consent until 28 days after the last administration of study treatment. Additionally all SAEs related to study medication (SAR) were recorded through the entire follow-up period, 18 months after last administration of treatment.
    Adverse event reporting additional description
    AEs were summarized by System Organ Class (SOC) and Preferred Term (PT), grade, and relationship to study treatment. In the summary by grade, only the worst case per PT for each patient will was counted, if a patient experiences more than one AE within a PT. All AEs were included in the summary by relationship to study treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Safety analysis Pazopanib+GEM
    Reporting group description
    		 -

    Reporting group title
    Safety Analysis Pazopanib
    Reporting group description
    		 -

    Serious adverse events
    		 Safety analysis Pazopanib+GEM Safety Analysis Pazopanib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 43 (60.47%)
    21 / 44 (47.73%)
         number of deaths (all causes)
    34
    37
         number of deaths resulting from adverse events
    3
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tumour pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Impaired healing
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fatigue
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Pyrexia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    1 / 6
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cough
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Paraparesis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Somnolence
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder perforation
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (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
    Diverticulitis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic disorder
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Safety analysis Pazopanib+GEM Safety Analysis Pazopanib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 43 (100.00%)
    44 / 44 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 44 (6.82%)
         occurrences all number
    3
    3
    Vascular disorders
    Haematoma
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    4
    0
    Hypertension
         subjects affected / exposed
    8 / 43 (18.60%)
    9 / 44 (20.45%)
         occurrences all number
    12
    12
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 44 (9.09%)
         occurrences all number
    5
    4
    Chills
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    14 / 43 (32.56%)
    17 / 44 (38.64%)
         occurrences all number
    25
    18
    General physical health deterioration
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 44 (2.27%)
         occurrences all number
    4
    1
    Local Swelling
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    1
    3
    Localised oedema
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Mucosal inflammation
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 44 (6.82%)
         occurrences all number
    4
    3
    Oedema
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 44 (6.82%)
         occurrences all number
    4
    3
    Pain
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 44 (9.09%)
         occurrences all number
    4
    4
    Pyrexia
         subjects affected / exposed
    10 / 43 (23.26%)
    2 / 44 (4.55%)
         occurrences all number
    13
    3
    Oedema peripheral
         subjects affected / exposed
    10 / 43 (23.26%)
    0 / 44 (0.00%)
         occurrences all number
    11
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    15 / 43 (34.88%)
    8 / 44 (18.18%)
         occurrences all number
    18
    13
    Dysphonia
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    1
    2
    Dyspnoea
         subjects affected / exposed
    9 / 43 (20.93%)
    6 / 44 (13.64%)
         occurrences all number
    11
    6
    Dyspnoea exertional
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 44 (9.09%)
         occurrences all number
    4
    5
    Epistaxis
         subjects affected / exposed
    7 / 43 (16.28%)
    0 / 44 (0.00%)
         occurrences all number
    11
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 44 (4.55%)
         occurrences all number
    2
    2
    Pleural effusion
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 44 (4.55%)
         occurrences all number
    4
    3
    Pneumothorax
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 44 (6.82%)
         occurrences all number
    6
    5
    Respiratory distress
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 44 (2.27%)
         occurrences all number
    4
    3
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    1
    2
    Sleep disorder
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 43 (23.26%)
    5 / 44 (11.36%)
         occurrences all number
    19
    8
    Aspartate aminotransferase increased
         subjects affected / exposed
    11 / 43 (25.58%)
    4 / 44 (9.09%)
         occurrences all number
    27
    6
    Blood alkaline phosphatase increased
         subjects affected / exposed
    7 / 43 (16.28%)
    2 / 44 (4.55%)
         occurrences all number
    8
    2
    Blood bilirubin increased
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 44 (2.27%)
         occurrences all number
    7
    1
    Blood creatinine increased
         subjects affected / exposed
    5 / 43 (11.63%)
    0 / 44 (0.00%)
         occurrences all number
    8
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    10 / 43 (23.26%)
    4 / 44 (9.09%)
         occurrences all number
    19
    7
    Platelet count decreased
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    7
    0
    Weight decreased
         subjects affected / exposed
    12 / 43 (27.91%)
    11 / 44 (25.00%)
         occurrences all number
    15
    12
    White blood cell count decreased
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    5
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Dizziness
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 44 (2.27%)
         occurrences all number
    4
    1
    Dysgeusia
         subjects affected / exposed
    5 / 43 (11.63%)
    7 / 44 (15.91%)
         occurrences all number
    5
    7
    Headache
         subjects affected / exposed
    7 / 43 (16.28%)
    3 / 44 (6.82%)
         occurrences all number
    8
    3
    Hypoaesthesia
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 44 (4.55%)
         occurrences all number
    3
    2
    Paraesthesia
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 44 (6.82%)
         occurrences all number
    1
    3
    Somnolence
         subjects affected / exposed
    19 / 43 (44.19%)
    11 / 44 (25.00%)
         occurrences all number
    27
    13
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    16 / 43 (37.21%)
    4 / 44 (9.09%)
         occurrences all number
    26
    7
    Leukopenia
         subjects affected / exposed
    20 / 43 (46.51%)
    3 / 44 (6.82%)
         occurrences all number
    53
    12
    Lymph node pain
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Neutropenia
         subjects affected / exposed
    11 / 43 (25.58%)
    2 / 44 (4.55%)
         occurrences all number
    36
    6
    Thrombocytopenia
         subjects affected / exposed
    25 / 43 (58.14%)
    6 / 44 (13.64%)
         occurrences all number
    69
    12
    Eye disorders
    Visual impairment
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    5 / 43 (11.63%)
    3 / 44 (6.82%)
         occurrences all number
    6
    3
    Abdominal pain
         subjects affected / exposed
    6 / 43 (13.95%)
    6 / 44 (13.64%)
         occurrences all number
    7
    6
    Abdominal pain lower
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 44 (2.27%)
         occurrences all number
    4
    1
    Abdominal pain upper
         subjects affected / exposed
    5 / 43 (11.63%)
    6 / 44 (13.64%)
         occurrences all number
    5
    6
    Constipation
         subjects affected / exposed
    12 / 43 (27.91%)
    3 / 44 (6.82%)
         occurrences all number
    13
    3
    Diarrhoea
         subjects affected / exposed
    26 / 43 (60.47%)
    18 / 44 (40.91%)
         occurrences all number
    42
    28
    Dry mouth
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    Dyspepsia
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 44 (6.82%)
         occurrences all number
    2
    3
    Nausea
         subjects affected / exposed
    22 / 43 (51.16%)
    18 / 44 (40.91%)
         occurrences all number
    28
    22
    Vomiting
         subjects affected / exposed
    11 / 43 (25.58%)
    8 / 44 (18.18%)
         occurrences all number
    16
    11
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 44 (2.27%)
         occurrences all number
    2
    1
    Erythema
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 44 (4.55%)
         occurrences all number
    3
    2
    Hair colour changes
         subjects affected / exposed
    4 / 43 (9.30%)
    3 / 44 (6.82%)
         occurrences all number
    4
    3
    Hyperhidrosis
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    1
    2
    Nail disorder
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 44 (4.55%)
         occurrences all number
    0
    2
    Night sweats
         subjects affected / exposed
    4 / 43 (9.30%)
    3 / 44 (6.82%)
         occurrences all number
    5
    4
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 44 (4.55%)
         occurrences all number
    5
    4
    Petechiae
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 44 (2.27%)
         occurrences all number
    2
    1
    Pruritus
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 44 (4.55%)
         occurrences all number
    2
    2
    Rash
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 44 (4.55%)
         occurrences all number
    4
    2
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 44 (2.27%)
         occurrences all number
    2
    2
    Nocturia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Renal failure
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    4
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    7 / 43 (16.28%)
    5 / 44 (11.36%)
         occurrences all number
    7
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 44 (4.55%)
         occurrences all number
    3
    3
    Back pain
         subjects affected / exposed
    5 / 43 (11.63%)
    5 / 44 (11.36%)
         occurrences all number
    6
    8
    Muscle spasms
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 44 (9.09%)
         occurrences all number
    4
    4
    Muscular weakness
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 43 (4.65%)
    4 / 44 (9.09%)
         occurrences all number
    3
    4
    Myalgia
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    4
    Pain in extremity
         subjects affected / exposed
    2 / 43 (4.65%)
    7 / 44 (15.91%)
         occurrences all number
    2
    9
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 44 (4.55%)
         occurrences all number
    3
    2
    Febrile infection
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Infection
         subjects affected / exposed
    10 / 43 (23.26%)
    5 / 44 (11.36%)
         occurrences all number
    13
    8
    Nasopharyngitis
         subjects affected / exposed
    11 / 43 (25.58%)
    3 / 44 (6.82%)
         occurrences all number
    12
    5
    Oral herpes
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Pneumonia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 43 (6.98%)
    5 / 44 (11.36%)
         occurrences all number
    7
    9
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 44 (4.55%)
         occurrences all number
    3
    2
    Cachexia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Decreased appetite
         subjects affected / exposed
    12 / 43 (27.91%)
    8 / 44 (18.18%)
         occurrences all number
    14
    8
    Hyperuricaemia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Hypokalaemia
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 44 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jul 2014
    Protocol Amendment N01 (17.07.2014) to protocol 2.0 (06-2011 ), submission of changes regarding the time frame of the analysis of the primary end-point. "The analysis of the primary end-point (progression free survival rate after 12 weeks) will be done after the last subject has obtained the End of Treatment. Secondary end-points (OS, TTP, response rate, toxicity and quality of live) will be analysed if the last subject has finished the follow-up period (last patient, last visit)", approved by the EC on 28.08.2014, implicit approval by CA.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 Aug 2013
    Temporary halt of the trial due to a fatal hepatic SAE which occurred in a further clinical study investigating the combination of gemcitabine and pazopanib for the treatment of patients with advanced soft tissue sarcoma
    19 Dec 2013

    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/33355646
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