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    Clinical Trial Results:
    Phase II Study of Weekly Cabazitaxel for Advanced Prostate Cancer in "Unfit" Hormone-Refractory Patients Previously Treated with Docetaxel.

    Summary
    EudraCT number
    		 2011-004627-12
    Trial protocol
    		 ES  
    Global end of trial date
    29 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2021
    First version publication date
    14 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CABASEM-SOGUG
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01518283
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SOGUG - Spanish Oncology Genitourinary Group
    Sponsor organisation address
    Calle Velázquez, 7, planta 3, Madrid , Spain, 28001
    Public contact
    Juan Luis Sanz, APICES SOLUCIONES, S.L., +34 91 816 68 04 +103, juanluis.sanz@apices.es
    Scientific contact
    Juan Luis Sanz, APICES SOLUCIONES, S.L., +34 91 816 68 04 +103, juanluis.sanz@apices.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
    29 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the activity of the weekly administration of cabazitaxel as time to PSA progression according to the PCCTWG II criteria.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 2012
    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: 74
    Worldwide total number of subjects
    74
    EEA total number of subjects
    74
    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)
    9
    From 65 to 84 years
    5
    85 years and over
    60

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in the study from 10th May 2012 until 24th April 2014.

    Pre-assignment
    Screening details
    		 Patients included in the study had to show histologically or cytologically confirmed adenocarcinoma of the prostate, undergone castration by orchiectomy or by LHRH agonists, clinical or radiological documented disease progression, metastasic disease, life expectancy of at least 12 weeks, ECOG-PS 2 and adequate organ function.

    Pre-assignment period milestones
    Number of subjects started
    		 74
    Number of subjects completed
    		 70

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening failure: 4
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Study treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cabazitaxel 10 mg/week

    Number of subjects in period 1 [1]
    		Study treatment
    Started
    70
    Completed
    0
    Not completed
    70
         Consent withdrawn by subject
    1
         Physician decision
    4
         Patient decision
    2
         Protocol non-compliance
    1
         Disease progression
    38
         Toxicity
    8
         Clinical deterioration
    3
         Adverse event not related with treatment
    8
         Exitus
    3
         Delay in administration upper to 15 days
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Four enrolled patients were screening failure and they did not receive study treatment.

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 70 70
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 4 4
        85 years and over
    		 58 58
    Age continuous
    Units: years
        median (full range (min-max))
    		 73.9 (54.6 to 85.7) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 70 70
    ECOG-PS
    Units: Subjects
        0)
    		 9 9
        1)
    		 11 11
        2)
    		 50 50
    Histological diagnosis
    Units: Subjects
        Prostate adenocarcinoma
    		 62 62
        Acinar adenocarcinoma of prostate
    		 4 4
        Prostate carcinoma
    		 2 2
        Ductal adenocarcinoma
    		 1 1
        Invasive adenocarcinoma of prostate
    		 1 1
    Histological diagnosis: Acinar adenocarcinoma of prostate
    Units: Subjects
        Yes
    		 4 4
        No
    		 66 66
    Histological diagnosis. Prostate carcinoma
    Units: Subjects
        Yes
    		 2 2
        No
    		 68 68
    TNM at diagnosis: T
    Units: Subjects
        T2
    		 16 16
        T3
    		 24 24
        T4
    		 5 5
        Tx
    		 17 17
        Not available
    		 8 8
    TNM at diagnosis: N
    Units: Subjects
        N0
    		 28 28
        N1
    		 14 14
        N2
    		 1 1
        NX
    		 18 18
        Not available
    		 9 9
    TNM at diagnosis: M
    Units: Subjects
        M0
    		 35 35
        M1
    		 30 30
        MX
    		 3 3
        Not available
    		 2 2
    TNM at diagnosis: Stage
    Units: Subjects
        II
    		 10 10
        III
    		 12 12
        IV
    		 37 37
        Not available
    		 11 11
    Current TNM: T
    Units: Subjects
        T2
    		 10 10
        T3
    		 21 21
        T4
    		 9 9
        Tx
    		 21 21
        Not available
    		 9 9
    Current TNM: N
    Units: Subjects
        N0
    		 21 21
        N1
    		 23 23
        N2
    		 1 1
        NX
    		 15 15
        Not available
    		 10 10
    Current TNM: M
    Units: Subjects
        M1
    		 70 70
    Current TNM: Stage
    Units: Subjects
        IV
    		 69 69
        Not available
    		 1 1
    Gleason score
    Units: Subjects
        <8
    		 35 35
        ≥8
    		 32 32
        Not available
    		 3 3
    Previous therapy: Radiotherapy
    Units: Subjects
        Yes
    		 41 41
        No
    		 29 29
    Weight
    Units: Kg
        median (full range (min-max))
    		 78.9 (46.0 to 118.0) -
    Height
    Units: Cm
        median (full range (min-max))
    		 168.0 (152.0 to 191.0) -
    Heart rate
    Units: lpm
        median (full range (min-max))
    		 78.0 (59.0 to 116.0) -
    Systolic pressure
    Units: mmHg
        median (full range (min-max))
    		 129.0 (88.0 to 173.0) -
    Dyastolic pressure
    Units: mmHg
        median (full range (min-max))
    		 76.0 (58.0 to 114.0) -
    Time since initial diagnosis
    Units: Months
        median (full range (min-max))
    		 71.1 (7.0 to 241.9) -
    Number of previous lines of treatment
    Units: Lines of treatment
        median (full range (min-max))
    		 2.0 (1.0 to 5.0) -

    End points

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    End points reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 -

    Primary: Biochemical progression-free survival at 12 weeks

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    End point title
    		 Biochemical progression-free survival at 12 weeks [1]
    End point description
    Biochemical progression-free survival was defined as the time elapsed, in months, from the time the patient start in the study until progression (PSA or radiological progression) or death for any cause.
    End point type
    Primary
    End point timeframe
    12 weeks
    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: No statistical analyses have been performed. Phase II non-comparative study
    End point values
    		 Study treatment
    Number of subjects analysed
    70
    Units: Percentage
        number (confidence interval 95%)
    68.6 (55.7 to 81.5)
    No statistical analyses for this end point

    Secondary: Biochemical progression-free survival

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    End point title
    		 Biochemical progression-free survival
    End point description
    Biochemical progression-free survival was defined as the time elapsed, in months, from the time the patient start in the study until progression (PSA or radiological progression) or death for any cause.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    70
    Units: Months
        median (confidence interval 95%)
    4.05 (2.7 to 5.4)
    No statistical analyses for this end point

    Secondary: Biochemical response rate 30%

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    End point title
    		 Biochemical response rate 30%
    End point description
    Biochemical response rate 30% has been defined as a reduction in PSA concentration greater than 30% from baseline.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    70
    Units: % of subjects
    number (not applicable)
        Response
    42.9
        No response
    57.1
    No statistical analyses for this end point

    Secondary: Biochemical response rate 50%

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    End point title
    		 Biochemical response rate 50%
    End point description
    Biochemical response rate 50% has been defined as a reduction in PSA concentration greater than 50% from baseline.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    70
    Units: % of subjects
    number (not applicable)
        Response
    34.3
        No response
    65.7
    No statistical analyses for this end point

    Secondary: Biochemical response rate 80%

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    End point title
    		 Biochemical response rate 80%
    End point description
    Biochemical response rate 80% has been defined as a reduction in PSA concentration greater than 80% from baseline.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    70
    Units: % of subjects
    number (not applicable)
        Response
    10.0
        No Response
    90.0
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Objective response has been calculated taking into account patients with complete response or partial response to treatment.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    70
    Units: % of subjects
        number (confidence interval 95%)
    5.7 (0.3 to 11.2)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival was defined as the time elapsed, in months, from the time the patient start into the study until death for any cause.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    70
    Units: Months
        median (confidence interval 95%)
    12.632 (8.2 to 17.8)
    No statistical analyses for this end point

    Secondary: Pain response according to BPI

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    End point title
    		 Pain response according to BPI
    End point description
    Pain response is defined as an increase of ≥ 2 points from baseline, with no increase in the analgesic score, or a ≥ 50% analgesic use reduction without increased pain, for at least 3 weeks with respect to the lowest value measured according to the BPI scale.
    End point type
    Secondary
    End point timeframe
    At baseline
    End point values
    		 Study treatment
    Number of subjects analysed
    66
    Units: Score
        median (full range (min-max))
    3.6 (0.0 to 8.8)
    No statistical analyses for this end point

    Secondary: Correlation of CTC response and progressión-free survival

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    End point title
    		 Correlation of CTC response and progressión-free survival
    End point description
    CTC response has been defined as a decrease in the absolute CTC value by at least 30% between the baseline assessment and the respectively timeframe. This value has been calculated based on the total number of evaluated patients (N=32 patients; Responders 19 patients; Non-responders 13 patients) There are statistically significant differences between responders and non-responders (P-value <0.013).
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Study treatment
    Number of subjects analysed
    32
    Units: Months
    median (confidence interval 95%)
        Non-responders (13 patients)
    3.06 (2.48 to 3.64)
        Responders (19 patients)
    5.79 (3.69 to 7.89)
    No statistical analyses for this end point

    Secondary: Correlation of CTC response and Overall survival

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    End point title
    		 Correlation of CTC response and Overall survival
    End point description
    CTC response has been defined as a decrease in the absolute CTC value by at least 30% between the baseline assessment and the respectively timeframe. This value has been calculated based on the total number of evaluated patients (N=32 patients; Responders 19 patients; No responders 13 patients). There are no statistically significant differences between responders and non-responders.
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Study treatment
    Number of subjects analysed
    32
    Units: Months
    median (confidence interval 95%)
        Non-responders (13 patients)
    7.20 (5.66 to 8.75)
        Responders (19 patients)
    15.86 (9.50 to 22.21)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until the end of treatment study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 70 (47.14%)
         number of deaths (all causes)
    59
         number of deaths resulting from adverse events
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder neoplasm
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombosis venous deep
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Febrile syndrome
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Asthenia
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdomen mimicking acute
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mucositis
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectorrhagia
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bowel obstruction
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal subobstruction
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cyclic vomiting syndrome
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary thromboembolism
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Chronic obstructive pulmonary disease exacerbation
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Hematuria
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Acute renal failure
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal function aggravated
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal insufficiency
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar pain
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Oral cavity infection
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory infection
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Flu
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatremia
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 70 (92.86%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 70 (8.57%)
         occurrences all number
    7
    Hypotension
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Pallor
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    53 / 70 (75.71%)
         occurrences all number
    148
    Oedema peripheral
         subjects affected / exposed
    7 / 70 (10.00%)
         occurrences all number
    10
    Mucosal inflammation
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    General physical health deterioration
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Pain
         subjects affected / exposed
    15 / 70 (21.43%)
         occurrences all number
    16
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    9 / 70 (12.86%)
         occurrences all number
    12
    Dysphonia
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Dyspnoea
         subjects affected / exposed
    9 / 70 (12.86%)
         occurrences all number
    11
    Epistaxis
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    Cough
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    5
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    7 / 70 (10.00%)
         occurrences all number
    8
    Dizziness
         subjects affected / exposed
    6 / 70 (8.57%)
         occurrences all number
    7
    Peripheral neuropathy
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    7
    Headache
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    5
    Neurotoxicity
         subjects affected / exposed
    6 / 70 (8.57%)
         occurrences all number
    6
    Paraesthesia
         subjects affected / exposed
    8 / 70 (11.43%)
         occurrences all number
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 70 (14.29%)
         occurrences all number
    29
    Leukopenia
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    31 / 70 (44.29%)
         occurrences all number
    73
    Dyspepsia
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    9
    Abdominal pain
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    7
    Constipation
         subjects affected / exposed
    14 / 70 (20.00%)
         occurrences all number
    24
    Nausea
         subjects affected / exposed
    22 / 70 (31.43%)
         occurrences all number
    31
    Lower abdominal pain
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Upper abdominal pain
         subjects affected / exposed
    8 / 70 (11.43%)
         occurrences all number
    9
    Abdominal discomfort
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    13 / 70 (18.57%)
         occurrences all number
    18
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    Haematuria
         subjects affected / exposed
    14 / 70 (20.00%)
         occurrences all number
    18
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    20 / 70 (28.57%)
         occurrences all number
    32
    Arthralgia
         subjects affected / exposed
    7 / 70 (10.00%)
         occurrences all number
    7
    Pain in extremity
         subjects affected / exposed
    7 / 70 (10.00%)
         occurrences all number
    12
    Groin pain
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    Bone pain
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Muscular weakness
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    5
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    4
    Respiratory tract infection
         subjects affected / exposed
    7 / 70 (10.00%)
         occurrences all number
    7
    Urinary tract infection
         subjects affected / exposed
    8 / 70 (11.43%)
         occurrences all number
    9
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    33 / 70 (47.14%)
         occurrences all number
    62
    Hypercholesterolemia
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    7
    Hyperglycaemia
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    9
    Hypocalcaemia
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4

    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.
    No statistical analyses have been performed. Phase II non-comparative study
    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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