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    Clinical Trial Results:
    A Phase II Study Investigating Upfront Pazopanib in Metastatic Clear Cell Renal Cancer [PANTHER]

    Summary
    EudraCT number
    		 2009-016675-29
    Trial protocol
    		 GB  
    Global end of trial date
    29 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2017
    First version publication date
    07 Apr 2017
    Other versions
    Summary report(s)
    		 Journal Article

    Trial information

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    Trial identification
    Sponsor protocol code
    RC200902
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01512186
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Queen Mary University London
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Thomas Powles, Centre for Experimental Cancer Medicine, bci-panther@qmul.ac.uk
    Scientific contact
    Thomas Powles, Centre for Experimental Cancer Medicine, bci-panther@qmul.ac.uk
    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
    09 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the clinical benefit of giving 14 weeks pazopanib to patients with metastatic kidney cancer prior to surgery to remove the cancerous kidney (nephrectomy).
    Protection of trial subjects
    Patients were closely monitored as part of the clinical trial. Pazopanib was chosen as having a good effect in renal cancer, but with a lower toxicity profile than the similar, licensed, drug, sunitinib. Therefore the effect of the drug was well known, and the trial was looking at the effect on the surgery. The additional scans given as part of the trial were reassuring for the patients also.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    48
    From 65 to 84 years
    45
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 6th July 2010 and 9 Dec 2015, 104 previously untreated patients with metastatic clear cell renal cancer were recruited to the PANTHER trial. This was a multicentre single-arm trial enrolling from 12 centres in the United Kingdom with nephrectomy services.

    Pre-assignment
    Screening details
    		 111 patients were screened for the trial, with 7 patients being ineligible.

    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
    Arm title
    		 Pazopanib
    Arm description
    		 intervention arm (single)
    Arm type
    		 single

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800mg PO OD (2 x 400mg tablets)

    Number of subjects in period 1
    		Pazopanib
    Started
    104
    Completed
    104

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 Overall trial

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 104 104
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 48 48
        From 65-84 years
    		 45 45
        85 years and over
    		 0 0
        missing
    		 11 11
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 63.8 (56.3 to 70.8) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 80 80
        not recorded
    		 0 0
    MSKCC prognostic risk
    Memorial Sloan Kettering Cancer Center score
    Units: Subjects
        Good
    		 0 0
        Intermediate
    		 83 83
        Poor
    		 18 18
        not recorded
    		 3 3
    Performance status
    Units: Subjects
        Grade 0
    		 29 29
        Grade 1
    		 63 63
        Grade 2
    		 9 9
        not recorded
    		 3 3
    Type of surgery
    Units: Subjects
        Open
    		 43 43
        Laparoscopic
    		 18 18
        Complete
    		 1 1
        Partial
    		 1 1
        none
    		 41 41
    T-stage at nephrectomy
    Units: Subjects
        T1
    		 6 6
        T2
    		 7 7
        T3
    		 41 41
        T4
    		 6 6
        no nephrectomy
    		 41 41
        Not recorded
    		 3 3
    Lung metastasis
    Units: Subjects
        yes
    		 90 90
        no
    		 14 14
    Bone metastasis
    Units: Subjects
        yes
    		 29 29
        no
    		 75 75
    Lymph node metastasis
    Units: Subjects
        yes
    		 48 48
        no
    		 56 56
    Liver metastasis
    Units: Subjects
        yes
    		 15 15
        no
    		 89 89
    Radiologic T stage at diagnosis
    Units: Subjects
        T1
    		 10 10
        T2
    		 29 29
        T3
    		 52 52
        T4
    		 11 11
        Not recorded
    		 2 2
    Primary tumour size
    Units: cm
        median (inter-quartile range (Q1-Q3))
    		 10 (8.3 to 11.6) -
    Subject analysis sets

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects

    Subject analysis set title
    clinical benefit
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients assessable for clinical benefit prior to planned nephrectomy. Four patients were not assessable.

    Subject analysis sets values
    		 Pazopanib clinical benefit
    Number of subjects
    104
    100
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    48
        From 65-84 years
    45
        85 years and over
    0
        missing
    11
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    63.8 (56.3 to 70.8)
    Gender categorical
    Units: Subjects
        Female
    24
        Male
    80
        not recorded
    0
    MSKCC prognostic risk
    Memorial Sloan Kettering Cancer Center score
    Units: Subjects
        Good
    0
        Intermediate
    83
        Poor
    18
        not recorded
    3
    Performance status
    Units: Subjects
        Grade 0
    29
        Grade 1
    63
        Grade 2
    9
        not recorded
    3
    Type of surgery
    Units: Subjects
        Open
    43
        Laparoscopic
    18
        Complete
    1
        Partial
    1
        none
    41
    T-stage at nephrectomy
    Units: Subjects
        T1
    6
        T2
    7
        T3
    41
        T4
    6
        no nephrectomy
    41
        Not recorded
    3
    Lung metastasis
    Units: Subjects
        yes
    90
        no
    14
    Bone metastasis
    Units: Subjects
        yes
    29
        no
    75
    Lymph node metastasis
    Units: Subjects
        yes
    48
        no
    56
    Liver metastasis
    Units: Subjects
        yes
    15
        no
    89
    Radiologic T stage at diagnosis
    Units: Subjects
        T1
    10
        T2
    29
        T3
    52
        T4
    11
        Not recorded
    2
    Primary tumour size
    Units: cm
        median (inter-quartile range (Q1-Q3))
    10 (8.3 to 11.6)
    10 (8.3 to 11.6)

    End points

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    End points reporting groups
    Reporting group title
    Pazopanib
    Reporting group description
    		 intervention arm (single)

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects

    Subject analysis set title
    clinical benefit
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients assessable for clinical benefit prior to planned nephrectomy. Four patients were not assessable.

    Primary: Clinical benefit

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    End point title
    		 Clinical benefit
    End point description
    Percentage of patients who obtained clinical benefit at 14 weeks.
    End point type
    Primary
    End point timeframe
    overall trial
    End point values
    		 Pazopanib clinical benefit
    Number of subjects analysed
    100
    100
    Units: rate
        number (confidence interval 95%)
    0.84 (0.75 to 0.91)
    0.84 (0.75 to 0.91)
    Statistical analysis title
    		 Clinical benefit
    Statistical analysis description
    number of patients that achieved clinical benefit
    Comparison groups
    Pazopanib v clinical benefit
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 rate
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.91
    Notes
    [1] - this analysis does compare two groups, only estimates the overall clinical benefit in the 'clinical benefit' group

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Date of randomisation until disease progression or death from any cause.
    End point values
    		 Pazopanib Pazopanib
    Number of subjects analysed
    104
    104
    Units: months
        median (confidence interval 95%)
    7.1 (6 to 9.2)
    7.1 (6 to 9.2)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Date of randomisation until death from any cause
    End point values
    		 Pazopanib Pazopanib
    Number of subjects analysed
    104
    104
    Units: months
        median (confidence interval 95%)
    22.7 (14.3 to 99999999)
    22.7 (14.3 to 99999999)
    No statistical analyses for this end point

    Secondary: Surgical complication

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    End point title
    		 Surgical complication
    End point description
    End point type
    Secondary
    End point timeframe
    Surgery complications observed from nephrectomy
    End point values
    		 Pazopanib Pazopanib
    Number of subjects analysed
    63
    63
    Units: Number of patients
    number (not applicable)
        Bleeding
    5
    5
        Delayed wound healing
    4
    4
        Splenectomy
    2
    2
        Elevated creatinine level
    1
    1
    Attachments
    		 Untitled (Filename: Nephrectomy data Table 1.docx)
    No statistical analyses for this end point

    Secondary: Response to pazopanib treatment

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    End point title
    		 Response to pazopanib treatment
    End point description
    Median size of primary tumour before and after pazopanib treatment
    End point type
    Secondary
    End point timeframe
    Length of pazopanib treatment
    End point values
    		 Pazopanib Pazopanib
    Number of subjects analysed
    104
    104
    Units: cm
    number (not applicable)
        Before Pazopanib
    10
    10
        After pazopanib
    8.3
    8.3
    Attachments
    		 Percentage Change of Primary Tumour
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial (overall period)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Pazopanib
    Reporting group description
    		 -

    Serious adverse events
    		 Pazopanib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    67 / 104 (64.42%)
         number of deaths (all causes)
    52
         number of deaths resulting from adverse events
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    4 / 104 (3.85%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    8 / 104 (7.69%)
         occurrences causally related to treatment / all
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Reproductive system and breast disorders
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    11 / 104 (10.58%)
         occurrences causally related to treatment / all
    1 / 13
         deaths causally related to treatment / all
    0 / 2
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Investigations
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    12 / 104 (11.54%)
         occurrences causally related to treatment / all
    3 / 13
         deaths causally related to treatment / all
    0 / 2
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    4 / 104 (3.85%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    5 / 104 (4.81%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    15 / 104 (14.42%)
         occurrences causally related to treatment / all
    8 / 19
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal and Urinary disorders
         subjects affected / exposed
    9 / 104 (8.65%)
         occurrences causally related to treatment / all
    1 / 10
         deaths causally related to treatment / all
    0 / 1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    4 / 104 (3.85%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    5 / 104 (4.81%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    6 / 104 (5.77%)
         occurrences causally related to treatment / all
    2 / 6
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pazopanib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    97 / 104 (93.27%)
    Investigations
    weight loss
         subjects affected / exposed
    10 / 104 (9.62%)
         occurrences all number
    14
    Vascular disorders
    hypertension
         subjects affected / exposed
    52 / 104 (50.00%)
         occurrences all number
    141
    General disorders and administration site conditions
    fatigue
         subjects affected / exposed
    88 / 104 (84.62%)
         occurrences all number
    345
    pain
         subjects affected / exposed
    33 / 104 (31.73%)
         occurrences all number
    87
    Gastrointestinal disorders
    constipation
         subjects affected / exposed
    16 / 104 (15.38%)
         occurrences all number
    29
    diarrhoea
         subjects affected / exposed
    55 / 104 (52.88%)
         occurrences all number
    222
    mucositis
         subjects affected / exposed
    15 / 104 (14.42%)
         occurrences all number
    27
    nausea
         subjects affected / exposed
    47 / 104 (45.19%)
         occurrences all number
    116
    taste change
         subjects affected / exposed
    20 / 104 (19.23%)
         occurrences all number
    41
    vomiting
         subjects affected / exposed
    20 / 104 (19.23%)
         occurrences all number
    39
    Skin and subcutaneous tissue disorders
    hand and foot syndrome
         subjects affected / exposed
    33 / 104 (31.73%)
         occurrences all number
    108
    Musculoskeletal and connective tissue disorders
    cramps
         subjects affected / exposed
    10 / 104 (9.62%)
         occurrences all number
    18
    Metabolism and nutrition disorders
    low appetite
         subjects affected / exposed
    14 / 104 (13.46%)
         occurrences all number
    22

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 May 2010
    Addition of a thyroid function check 12-weeks prior to trial entry Expansion of exclusion criteria relating to cardiac function - 'Prolonged QT Interval >480msecs or a history of prolonged QT interval >480msecs' Post-surgery visit timepoints changed from 2,6,12 weeks to 4,8,12 weeks.
    22 Sep 2010
    Change of Principal Investigators only
    06 Sep 2011
    Additional of an exclusion criteria to prohibit patients to take part in the GE-135-009 study entering the PANTHER trial
    04 Apr 2012
    Removal of exclusion criteria prohibiting entry to the GE-135-009 study (this study never commenced). 6 weekly MRI changed to 4-weekly. Typographical error in PIS relating to IMP dosing.
    22 May 2012
    Addition of a central facility only
    19 Aug 2014
    Change of Principal Investigators only
    12 Feb 2015
    Removal of central review from protocol Clarification of end of study definition and analysis timepoints
    04 Feb 2016
    Change of Principal Investigator only

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27254750
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