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    Clinical Trial Results:
    Pilot study of cabozantinib efficacy, safety and tolerability in metastatic renal carcinoma in aged fragile patients: CABOMAYOR study

    Summary
    EudraCT number
    		 2019-001639-30
    Trial protocol
    		 ES  
    Global end of trial date
    21 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2024
    First version publication date
    20 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CABOMAYOR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04134390
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Spanish Oncology Genitourinary Group – SOGUG
    Sponsor organisation address
    Velázquez, 7, 3rd floor, Madrid, Spain, 28001
    Public contact
    Isabel Benítez García-Mauricio, Spanish Oncology Genitourinary Group - SOGUG, 0034 671 42 23 25, projectmanager@sogug.es
    Scientific contact
    Isabel Grau Miró, Spanish Oncology Genitourinary Group - SOGUG, 0034 610 28 69 15, trialmanager@sogug.es
    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
    06 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cabozantinib efficacy (Objective Response Rate (ORR) as evaluated by RECIST 1.1 criteria) in previously untreated aged population with metastatic renal cell carcinoma (mRCC).
    Protection of trial subjects
    Informed consent has to be obtained prior to initiation of any clinical screening procedure that is performed solely for the purpose of determining eligibility for research; however, evaluations performed as part of routine care prior to informed consent could be utilized as screening evaluations if they fall within the 28-day screening window. Physical examination, hematology, biochemistry, ECG, vital signs, and evaluation of the tumor were made before the inclusion of the patient in the study and during the study treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    0
    From 65 to 84 years
    21
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of the 38 patients that signed the informed consent, 14 were screening failures and 24 patients have been analysed. All patients included in the analysis received study treatment.

    Pre-assignment
    Screening details
    		 All patients that met selection critera and signed the informed consent form were included in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Cabozantinib 40 mg p.o. once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabozantinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cabozantinib was administered as an oral single 40 mg dose once daily in 28-day cycles. After a period of 4 weeks and if 40 mg is considered tolerated, dose could be escalated to 60 mg to avoid suboptimal exposure to the drug. If this dose was not tolerated, it was de-escalated to 40 mg again. If the dose of 40 mg was not tolerated, a de-escalation to 20 mg, temporary interruption, or stopping cabozantinib were possible.

    Number of subjects in period 1
    		Experimental
    Started
    24
    Completed
    24

    Baseline characteristics

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

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        From 65-84 years
    		 21 21
        85 years and over
    		 3 3
    Age continuous
    Units: years
        median (standard deviation)
    		 78.6 ( 4.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 15 15
    Race
    Units: Subjects
        Caucasian
    		 24 24
    ECOG-PS
    Units: Subjects
        ECOG-PS 0
    		 16 16
        ECOG-PS 1
    		 8 8
    Prior surgery
    Units: Subjects
        Yes
    		 16 16
        No
    		 8 8
    Prior radiotherapy
    Units: Subjects
        Yes
    		 7 7
        No
    		 17 17
    Prior chemotherapy
    Units: Subjects
        Yes
    		 1 1
        No
    		 23 23
    Pulmonary metastasis
    Units: Subjects
        Yes
    		 16 16
        No
    		 8 8
    Number of locations
    Units: Subjects
        1 location
    		 7 7
        2 locations
    		 10 10
        3 locations
    		 5 5
        4 locations
    		 2 2
    Number of patients with treatment interruption
    Units: Subjects
        Yes
    		 17 17
        No
    		 7 7
    Number of patients with dose modification
    Units: Subjects
        Yes
    		 14 14
        No
    		 10 10
    IMDC classification
    Units: Subjects
        Favorable risk
    		 8 8
        Intermediate risk
    		 10 10
        Poor risk
    		 2 2
        Not available
    		 4 4
    Relative Cabozantinib dose intensity
    Units: Percentage
        arithmetic mean (standard deviation)
    		 78 ( 22 ) -
    Treatment time in months
    Units: Months
        arithmetic mean (standard deviation)
    		 11.9 ( 11.5 ) -
    Subject analysis sets

    Subject analysis set title
    Overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Received study medication

    Subject analysis sets values
    		 Overall
    Number of subjects
    24
    Age categorical
    Units: Subjects
        From 65-84 years
    21
        85 years and over
    3
    Age continuous
    Units: years
        median (standard deviation)
    78.6 ( 4.4 )
    Gender categorical
    Units: Subjects
        Female
    9
        Male
    15
    Race
    Units: Subjects
        Caucasian
    24
    ECOG-PS
    Units: Subjects
        ECOG-PS 0
    16
        ECOG-PS 1
    8
    Prior surgery
    Units: Subjects
        Yes
    16
        No
    8
    Prior radiotherapy
    Units: Subjects
        Yes
    7
        No
    17
    Prior chemotherapy
    Units: Subjects
        Yes
    1
        No
    23
    Pulmonary metastasis
    Units: Subjects
        Yes
    16
        No
    8
    Number of locations
    Units: Subjects
        1 location
    7
        2 locations
    10
        3 locations
    5
        4 locations
    2
    Number of patients with treatment interruption
    Units: Subjects
        Yes
    17
        No
    7
    Number of patients with dose modification
    Units: Subjects
        Yes
    14
        No
    10
    IMDC classification
    Units: Subjects
        Favorable risk
    8
        Intermediate risk
    10
        Poor risk
    2
        Not available
    4
    Relative Cabozantinib dose intensity
    Units: Percentage
        arithmetic mean (standard deviation)
    78 ( 22 )
    Treatment time in months
    Units: Months
        arithmetic mean (standard deviation)
    11.9 ( 11.5 )

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Cabozantinib 40 mg p.o. once daily.

    Subject analysis set title
    Overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Received study medication

    Primary: Objective response rate

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    End point title
    		 Objective response rate [1]
    End point description
    Complete Response (CR) + Partial Response (PR) evaluated by RECIST 1.1 criteria according to investigator criteria.
    End point type
    Primary
    End point timeframe
    Every three months
    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: Only one arm. No statistical analysis performed.
    End point values
    		 Experimental Overall
    Number of subjects analysed
    24
    24
    Units: Patients
        Yes
    7
    7
        No
    17
    17
    No statistical analyses for this end point

    Secondary: Clinical benefit rate

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    End point title
    		 Clinical benefit rate
    End point description
    Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated by RECIST 1.1 criteria according to investigator criteria.
    End point type
    Secondary
    End point timeframe
    Every three months
    End point values
    		 Experimental Overall
    Number of subjects analysed
    24
    24
    Units: Patients
        Yes
    18
    18
        No
    6
    6
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    PFS is defined as the time in months since the patient’s study enrolment until patient progression according to RECIST 1.1 criteria.
    End point type
    Secondary
    End point timeframe
    Every three months
    End point values
    		 Experimental Overall
    Number of subjects analysed
    24
    24
    Units: month
        median (confidence interval 95%)
    2.8 (2.0 to 3.6)
    2.8 (2.0 to 3.6)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    OS is defined as the time in months since the patient’s study enrolment until death.
    End point type
    Secondary
    End point timeframe
    Every three months
    End point values
    		 Experimental Overall
    Number of subjects analysed
    24
    24
    Units: month
        median (confidence interval 95%)
    33.7 (20.5 to 46.8)
    33.7 (20.5 to 46.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During study treatment.
    Adverse event reporting additional description
    No additional description.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 24 (45.83%)
         number of deaths (all causes)
    12
         number of deaths resulting from adverse events
    4
    Injury, poisoning and procedural complications
    Expired product administered
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Medication error
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Parkinsonism
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Colitis ischaemic
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Oliguria
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
    Vascular disorders
    Intermittent claudication
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Hypertension
         subjects affected / exposed
    5 / 24 (20.83%)
         occurrences all number
    14
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    14 / 24 (58.33%)
         occurrences all number
    26
    Oedema
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    5
    Mucosal inflammation
         subjects affected / exposed
    8 / 24 (33.33%)
         occurrences all number
    10
    Discomfort
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Social circumstances
    Loss of personal independence in daily activities
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Aphonia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Dysphonia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Cough
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    3
    Investigations
    Creatine urine decreased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4
    Amylase increased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    8
    Blood creatine increased
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    9
    Blood phosphorus decreased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4
    Blood glucose increased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    9
    Weight decreased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    8
    Glomerular filtration rate decreased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Dysgeusia
         subjects affected / exposed
    8 / 24 (33.33%)
         occurrences all number
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 24 (25.00%)
         occurrences all number
    17
    Thrombocytopenia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 24 (54.17%)
         occurrences all number
    24
    Dyspepsia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Abdominal discomfort
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    5 / 24 (20.83%)
         occurrences all number
    5
    Skin toxicity
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Proteinuria
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    5
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    5 / 24 (20.83%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    4
    Pain in extremity
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 24 (33.33%)
         occurrences all number
    12
    Gout
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Hypocalcaemia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4
    Hypophosphataemia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Hypomagnesaemia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The number of patients recruited was lower than expected, so the results should be interpreted with caution.
    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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