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    Clinical Trial Results:
    Phase II study of pazopanib in patients with progressive recurrent and/or metastatic salivary gland carcinoma

    Summary
    EudraCT number
    		 2012-004408-36
    Trial protocol
    		 FR  
    Global end of trial date
    09 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2023
    First version publication date
    06 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HN02-UC-0130/1205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02393820
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75013
    Public contact
    Nourredine AIT-RAHMOUNE, UNICANCER, 33 1 71 93 67 04, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT-RAHMOUNE, UNICANCER, 33 1 71 93 67 04, n.ait-rahmoune@unicancer.fr
    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
    20 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the efficacy of pazopanib for treating patients with recurrent and/or metastatic salivary gland cancers, in terms of the 6-month progression-free survival (PFS) rate.
    Protection of trial subjects
    This study was conducted in accordance with the Declaration of Helsinki (1964) and subsequent amendments, ICH Good Clinical Practice (GCP) Guidelines (CPMP/ICH/135/95), the European Directive (2001/20/CE) and the applicable local regulatory requirements and laws. Furthermore, independent Ethics Committees reviewed and gave favorable opinions to the study documents, including the initial protocol and all subsequent amendments, and all information and documents provided to subjects/patients. Written informed consent was obtained from all patients prior to enrollment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Aug 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    44
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 PACSA ORL02 was designed as a multicentric, open-label, single-arm, non-randomised phase II study in patients who were suffering from progressive recurrent and/or metastatic salivary gland cancers. Patients with salivary adenoid cystic carcinomas (ACC) and non-ACC were included in the study. Recruitment only in France.

    Pre-assignment
    Screening details
    		 Patients with relapse and/or metastatic salivary gland cancer : salivary adenoid cystic carcinomas (ACC) ans non-ACC. Confirmed disease progression using 2 tumour assessments within the 6 months before inclusion. The tumour assessment confirming disease progression had to be within 2 months of inclusion.

    Pre-assignment period milestones
    Number of subjects started
    		 63
    Number of subjects completed
    		 63

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adenoid cystic carcinoma (ACC)
    Arm description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the ACC subgroup.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib (Votrient®) was administered orally 800 mg once daily (4 x 200-mg tablets)

    Arm title
    		 Non-Adenoid Cystic Carcinoma (Non ACC)
    Arm description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the Non ACC subgroup.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib (Votrient®) was administered orally 800 mg once daily (4 x 200-mg tablets)

    Number of subjects in period 1
    		Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC)
    Started
    45
    18
    Completed
    0
    0
    Not completed
    45
    18
         Disease progression
    28
    12
         Adverse event, non-fatal
    6
    4
         Death
    3
    -
         Other reason
    1
    1
         Investigator decision
    2
    1
         Protocol deviation
    5
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adenoid cystic carcinoma (ACC)
    Reporting group description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the ACC subgroup.

    Reporting group title
    Non-Adenoid Cystic Carcinoma (Non ACC)
    Reporting group description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the Non ACC subgroup.

    Reporting group values
    		 Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC) Total
    Number of subjects
    		 45 18 63
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 29 15 44
        From 65-84 years
    		 16 3 19
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 58 (27 to 84) 59 (28 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 27 6 33
        Male
    		 18 12 30
    Metastatic at diagnosis
    Units: Subjects
        Yes
    		 6 1 7
        No
    		 39 17 56
    Metastatic progression at enrolment
    Units: Subjects
        Yes
    		 44 12 56
        No
    		 1 6 7
    Loco-regional recurrence at enrolment,
    Units: Subjects
        Yes
    		 19 15 34
        No
    		 26 3 29
    Site of primary tumour: Major salivary glands
    Units: Subjects
        Yes
    		 23 17 40
        No
    		 22 1 23
    Site of primary tumour: Major and minor salivary glands
    Units: Subjects
        Yes
    		 3 0 3
        No
    		 42 18 60
    Site of primary tumour: Minor salivary glands
    Units: Subjects
        Yes
    		 19 1 20
        No
    		 26 17 43

    End points

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    End points reporting groups
    Reporting group title
    Adenoid cystic carcinoma (ACC)
    Reporting group description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the ACC subgroup.

    Reporting group title
    Non-Adenoid Cystic Carcinoma (Non ACC)
    Reporting group description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the Non ACC subgroup.

    Primary: The 6-month progression-free survival (PFS) rate.

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    End point title
    		 The 6-month progression-free survival (PFS) rate. [1]
    End point description
    The primary endpoint was the 6-month progression-free survival (PFS) rate. Disease progression or death of any cause were considered as PFS events. The PFS rates will be estimated and presented with the associated 95% CI.
    End point type
    Primary
    End point timeframe
    6 weeks after treatment initiation
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was not designed to compare ACC and Non-ACC population. Thus, statistical comparisons by hypothesis tests between groups were not planned.
    End point values
    		 Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC)
    Number of subjects analysed
    45
    18
    Units: percent
    number (confidence interval 95%)
        Response rate
    47 (33 to 61)
    50 (29 to 71)
    No statistical analyses for this end point

    Secondary: Secondary endpoint:Objective response rate (ORR)

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    End point title
    		 Secondary endpoint:Objective response rate (ORR)
    End point description
    The ORR was defined as the proportion of patients with complete (CR) or partial responses (PR), according to RECIST v1.0.
    End point type
    Secondary
    End point timeframe
    The tumour assessments, performed at baseline (within 14 days of starting treatment) and at 12 weeks (after 3 cycles of treatment), were used to assess the 12-week ORR.
    End point values
    		 Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC)
    Number of subjects analysed
    45
    18
    Units: percent
    median (confidence interval 95%)
        median (confidence interval 95%)
    2 (0 to 12)
    6 (0 to 27)
    No statistical analyses for this end point

    Secondary: Secondary: progression-free survival (PFS)

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    End point title
    		 Secondary: progression-free survival (PFS)
    End point description
    PFS was defined as the time interval between start of treatment and first document disease progression or death from any cause, whichever occurred first. The tumour assessments, performed at baseline (within 14 days of starting treatment) and then every 12 weeks until disease progression, were used to assess PFS.
    End point type
    Secondary
    End point timeframe
    The tumour assessments, performed at baseline (within 14 days of starting treatment) and then every 12 weeks until disease progression, were used to assess PFS.
    End point values
    		 Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC)
    Number of subjects analysed
    45
    18
    Units: percent
    median (confidence interval 95%)
        median (confidence interval 95%)
    5.93 (3.67 to 8.20)
    6.74 (2.59 to 8.23)
    No statistical analyses for this end point

    Secondary: Secondary: Overall survival

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    End point title
    		 Secondary: Overall survival
    End point description
    OS was defined as the time interval between start of treatment and death from any cause, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    OS was defined as the time interval between start of treatment and death from any cause, whichever occurred first.
    End point values
    		 Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC)
    Number of subjects analysed
    45 [2]
    18 [3]
    Units: Months
    number (not applicable)
        median (confidence interval 95%)
    17.0
    0
    Notes
    [2] - The median OS was 17.0 months (95% CI: 10.7-not reached).
    [3] - The median OS has not been reached.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion until 30 days after end of treatment (up to 1 year).
    Adverse event reporting additional description
    Safety analysis
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Adenoid cystic carcinoma (ACC)
    Reporting group description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the ACC subgroup.

    Reporting group title
    Non-Adenoid Cystic Carcinoma (Non ACC)
    Reporting group description
    		 Salivary Glands Carcinoma were separated in two cohorts/sub-groups: Adenoid Cystic Carcinoma (ACC) and Non-Adenoid Cystic Carcinoma (Non ACC). In this "Arm" we reported results from the Non ACC subgroup.

    Serious adverse events
    		 Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 49 (51.02%)
    11 / 20 (55.00%)
         number of deaths (all causes)
    17
    6
         number of deaths resulting from adverse events
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumor progression
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    hypertension arterial
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischemic stroke
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (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
    Chest pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Performance status decreased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchopneumopathy
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumopathy
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hemoptysis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    biopsy of lung
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elevated liver enzymes
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Left ventricular systolic dysfunction
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (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
    Brain abscess
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocephalus
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Epigastralgia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorder gastrointestinal
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Mucositis oral
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced hepatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cytolysis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin erosion
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    staphylococcus aureus skin infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis of face
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (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: 3%
    Non-serious adverse events
    		 Adenoid cystic carcinoma (ACC) Non-Adenoid Cystic Carcinoma (Non ACC)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 49 (100.00%)
    20 / 20 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumoral pain
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 20 (20.00%)
         occurrences all number
    2
    27
    Vascular disorders
    Hot flushes
         subjects affected / exposed
    5 / 49 (10.20%)
    3 / 20 (15.00%)
         occurrences all number
    11
    30
    Hypertension
         subjects affected / exposed
    21 / 49 (42.86%)
    8 / 20 (40.00%)
         occurrences all number
    165
    43
    Hypotension
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 20 (10.00%)
         occurrences all number
    12
    4
    Paleness
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    43 / 49 (87.76%)
    13 / 20 (65.00%)
         occurrences all number
    324
    119
    Pain
         subjects affected / exposed
    6 / 49 (12.24%)
    1 / 20 (5.00%)
         occurrences all number
    18
    8
    Facial pain
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    4
    7
    Thoracic pain
         subjects affected / exposed
    11 / 49 (22.45%)
    2 / 20 (10.00%)
         occurrences all number
    38
    2
    Deterioration of general health status
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    Fever
         subjects affected / exposed
    8 / 49 (16.33%)
    3 / 20 (15.00%)
         occurrences all number
    9
    4
    Shivering
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 20 (0.00%)
         occurrences all number
    10
    0
    Mucous inflammation
         subjects affected / exposed
    19 / 49 (38.78%)
    4 / 20 (20.00%)
         occurrences all number
    19
    11
    Feeling of faintness
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 20 (20.00%)
         occurrences all number
    3
    5
    Facial oedema
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 20 (10.00%)
         occurrences all number
    17
    6
    Peripheral oedema
         subjects affected / exposed
    7 / 49 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    42
    1
    Flu syndrome
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Xerosis
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 20 (5.00%)
         occurrences all number
    22
    10
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 49 (6.12%)
    4 / 20 (20.00%)
         occurrences all number
    13
    5
    Dyspnoea
         subjects affected / exposed
    13 / 49 (26.53%)
    6 / 20 (30.00%)
         occurrences all number
    43
    17
    Epistaxis
         subjects affected / exposed
    15 / 49 (30.61%)
    5 / 20 (25.00%)
         occurrences all number
    59
    9
    Nasal obstruction
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    6
    0
    Pneumothorax
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 20 (10.00%)
         occurrences all number
    7
    11
    Cough
         subjects affected / exposed
    13 / 49 (26.53%)
    5 / 20 (25.00%)
         occurrences all number
    52
    20
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 49 (8.16%)
    4 / 20 (20.00%)
         occurrences all number
    7
    8
    Depression
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 20 (10.00%)
         occurrences all number
    10
    29
    Insomnia
         subjects affected / exposed
    6 / 49 (12.24%)
    5 / 20 (25.00%)
         occurrences all number
    26
    17
    Sleep disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    40
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    5
    1
    Headache
         subjects affected / exposed
    16 / 49 (32.65%)
    10 / 20 (50.00%)
         occurrences all number
    45
    49
    Dysgeusia
         subjects affected / exposed
    10 / 49 (20.41%)
    3 / 20 (15.00%)
         occurrences all number
    62
    13
    Migraine
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    9
    0
    Neuralgia
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    10
    5
    Neuromyopathy
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    12
    0
    Peripheral neuropathy
         subjects affected / exposed
    5 / 49 (10.20%)
    0 / 20 (0.00%)
         occurrences all number
    11
    0
    Palm-chin reflex
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 20 (10.00%)
         occurrences all number
    21
    3
    Burning sensation
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    8
    0
    Dizziness
         subjects affected / exposed
    8 / 49 (16.33%)
    5 / 20 (25.00%)
         occurrences all number
    19
    23
    Somnolence
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 20 (10.00%)
         occurrences all number
    12
    13
    Equilibrium problems
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    10
    38
    trembling
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    6
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    3 / 49 (6.12%)
    3 / 20 (15.00%)
         occurrences all number
    8
    10
    Ear pain
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    15
    1
    Vertigo
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 20 (15.00%)
         occurrences all number
    2
    30
    Eye disorders
    Increased lachrymal secretion
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    14
    9
    Conjunctivitis
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 20 (0.00%)
         occurrences all number
    7
    0
    Eye pain
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Visual defects
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Periorbital oedema
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    22
    0
    Visual problems
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 20 (5.00%)
         occurrences all number
    22
    1
    Gastrointestinal disorders
    Apyalism
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    7
    0
    Dry mouth
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    6
    16
    Constipation
         subjects affected / exposed
    16 / 49 (32.65%)
    5 / 20 (25.00%)
         occurrences all number
    62
    11
    Diarrhoea
         subjects affected / exposed
    32 / 49 (65.31%)
    6 / 20 (30.00%)
         occurrences all number
    259
    51
    Abdominal distention
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 20 (10.00%)
         occurrences all number
    2
    3
    Abdominal pain
         subjects affected / exposed
    19 / 49 (38.78%)
    9 / 20 (45.00%)
         occurrences all number
    19
    9
    Mouth pain
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    10
    0
    Painful teeth
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    13
    10
    Dyspepsia
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Dysphagia
         subjects affected / exposed
    7 / 49 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    30
    4
    Flatulence
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    5
    1
    Haemorrhoids
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 20 (10.00%)
         occurrences all number
    7
    16
    Nausea
         subjects affected / exposed
    29 / 49 (59.18%)
    12 / 20 (60.00%)
         occurrences all number
    117
    21
    Ptyalism
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Gastro-oesophageal reflux
         subjects affected / exposed
    8 / 49 (16.33%)
    0 / 20 (0.00%)
         occurrences all number
    22
    0
    Bleeding gums
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 20 (0.00%)
         occurrences all number
    9
    0
    Stomatitis
         subjects affected / exposed
    8 / 49 (16.33%)
    0 / 20 (0.00%)
         occurrences all number
    17
    0
    Vomiting
         subjects affected / exposed
    12 / 49 (24.49%)
    8 / 20 (40.00%)
         occurrences all number
    23
    10
    Glossodynia
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    5
    Hepatobiliary disorders
    Hepatocellular lesions
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 20 (5.00%)
         occurrences all number
    24
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    10 / 49 (20.41%)
    2 / 20 (10.00%)
         occurrences all number
    72
    36
    Hair colour changes
         subjects affected / exposed
    11 / 49 (22.45%)
    4 / 20 (20.00%)
         occurrences all number
    146
    50
    Pruritis
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 20 (5.00%)
         occurrences all number
    14
    2
    Rash
         subjects affected / exposed
    6 / 49 (12.24%)
    0 / 20 (0.00%)
         occurrences all number
    33
    0
    Erythema
         subjects affected / exposed
    4 / 49 (8.16%)
    3 / 20 (15.00%)
         occurrences all number
    25
    5
    Erythrose
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    10
    0
    Skin pain
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Acral syndrome
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Dry skin
         subjects affected / exposed
    6 / 49 (12.24%)
    4 / 20 (20.00%)
         occurrences all number
    16
    65
    Dysphonia
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 20 (5.00%)
         occurrences all number
    13
    1
    Renal and urinary disorders
    Kidney failure
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Proteinuria
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 20 (10.00%)
         occurrences all number
    1
    3
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    7
    2
    Hypothyroidism
         subjects affected / exposed
    10 / 49 (20.41%)
    5 / 20 (25.00%)
         occurrences all number
    26
    16
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 49 (12.24%)
    2 / 20 (10.00%)
         occurrences all number
    33
    10
    Cervicalgia
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 20 (10.00%)
         occurrences all number
    19
    3
    Muscle contractures
         subjects affected / exposed
    12 / 49 (24.49%)
    2 / 20 (10.00%)
         occurrences all number
    53
    18
    Dorsalgia
         subjects affected / exposed
    9 / 49 (18.37%)
    1 / 20 (5.00%)
         occurrences all number
    26
    1
    Jaw pain
         subjects affected / exposed
    5 / 49 (10.20%)
    2 / 20 (10.00%)
         occurrences all number
    15
    6
    Musculo-skeletal pain
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 20 (10.00%)
         occurrences all number
    3
    2
    Bone pain
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 20 (10.00%)
         occurrences all number
    8
    6
    Pain of the extremities
         subjects affected / exposed
    3 / 49 (6.12%)
    3 / 20 (15.00%)
         occurrences all number
    12
    7
    Muscle weakness
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    5 / 49 (10.20%)
    3 / 20 (15.00%)
         occurrences all number
    26
    5
    Trismus (lockjaw)
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 20 (10.00%)
         occurrences all number
    6
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Ear infection
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Dental infection
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    8
    3
    Pulmonary infection
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 20 (5.00%)
         occurrences all number
    5
    2
    Oral mycosis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Rhinitis
         subjects affected / exposed
    8 / 49 (16.33%)
    1 / 20 (5.00%)
         occurrences all number
    31
    7
    Gastroenteritis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Rhinolaryngitis
         subjects affected / exposed
    0 / 49 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    Sinusitis
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 20 (10.00%)
         occurrences all number
    3
    4
    Metabolism and nutrition disorders
    Diminished appetite
         subjects affected / exposed
    19 / 49 (38.78%)
    5 / 20 (25.00%)
         occurrences all number
    59
    30

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2013
    -The surveillance of liver function during pazopanib treatment had been updated. Consequently, the protocol and informed consent forms were modified. -Details concerning the thoraco-abdominal-pelvic scan and the direct bilirubin testing required were clarified.
    12 Oct 2013
    -Modification of Annex 8 concerning the blood pressure measurements. The protocol was updated to indicated that 3 measures, with a minimum interval of 3 min, were to be made. The average of the 3 readings would be recorded. -Following the issuing of a SUSAR in another clinical study using pazopanib. The study documents were modified to indicate that the pazopanib tablet was to be ingested whole (not broken nor crushed) with water, at least an hour before or 2 h after breakfast. -The protocol contact details were updated. -Updating of the investigator list.
    10 Apr 2014
    -The study documents were updated following the release of version 10 (22-Feb-2013) of the investigator brochure (pazopanib). -The protocol contact details were updated. -Updating of the investigator list.
    22 Jul 2014
    -Clarification of the Inclusion criterion N°2 to clearly define disease progression. In addition, patients treated between diagnosis of disease progression and study inclusion were not eligible. -The ethics committee was provided with version 11 of the investigator brochure (pazopanib). The protocol did not require updating following the release of this new version. -Updating of the investigator list
    18 Feb 2015
    -Modification of the eligibility criteria: -Addition of inclusion criteria requiring normal thyroid function (TSH level >0.3 µU/mL but <6 µU/mL; free T4 levels >9 pmol/L but <29 pmol/L). -Addition of a non-inclusion criterion excluding patients with severe or uncontrolled general medical conditions that in the investigator’s opinion would interfere with the study conduct. -Updating of the investigator brochure. -Updating of sponsor details.
    24 Mar 2016
    Updating of the investigator list.
    03 Aug 2016
    -The protocol was updated to allow the use of the commercial stock of pazopanib (bottles containing 30 tablets instead of 34 tablets). The dose remained unchanged at 200 mg/tablet. -Updating of the expected adverse events (annex 5 of the protocol). -Updating of the sponsor contact details
    10 May 2017
    Updating of the investigator list.

    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
    For support, Contact us.
    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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