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    Clinical Trial Results:
    A randomised Phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium

    Summary
    EudraCT number
    		 2012-002826-55
    Trial protocol
    		 ES   NL  
    Global end of trial date
    12 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2018
    First version publication date
    16 Feb 2018
    Other versions
    Summary report(s)
    		 Secavin manuscript Ann Oncol. 2017 Jul 1;28(7):1517-1522. doi: 10.1093/annonc/mdx186.
    Secavin Final Study Report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SECAVIN-12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01830231
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    APRO
    Sponsor organisation address
    Paseo Bonanova, 56 - Bj 2 Barcelona , Barcelona, Spain, 28023
    Public contact
    Inmaculada Musté, Per a la Recerca Oncològica (APRO), 0034 93248 30 00, oncologia.apro@gmail.com
    Scientific contact
    Inmaculada Musté, Per a la Recerca Oncològica (APRO), 0034 93248 30 00, oncologia.apro@gmail.com
    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
    16 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Phase II part: -efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU. Phase III part: -efficacy of cabazitaxel compared to vinflunine in terms of improved OS of subjects with metastatic or locally advanced, previously treated TCCU.
    Protection of trial subjects
    As per IAC recommendations the phase III part of the study did not go ahead.
    Background therapy
    		 There was not any background therapy
    Evidence for comparator
    		 Vinflunine is a reasonable option for patients with advanced urothelial cancer, and currently is the only second-line treatment approved in monotherapy for adult patients with advanced TCCU after failure of platinum-containing therapy. In a recent phase III study evaluating vinflunine plus Best Supportive Care (BSC) versus BSC alone as second-line treatment, it revealed moderate activity (ORR, 8.6%) and a clinical benefit with a favourable safety profile. A beneficial effect on survival in favour of vinflunine+BSC vs. BSC was observed (6.9 v 4.3 months), with the difference being statistically significant (P=0.040) in the eligible population. A multivariate Cox analysis adjusting for prognostic factors showed statistically significant effect of vinflunine on OS (P=0.036), reducing the death risk by 23% (HR= 0.77; 95% CI, 0.61 to 0.98). Cabazitaxel (XRP6258) is a new taxoid, which promotes tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel. In vitro, cabazitaxel demonstrates cytotoxic activity equivalent to docetaxel. Cabazitaxel demonstrated a broad spectrum of antitumoural activity against advanced human tumour xenografts in mice. Cabazitaxel is active in tumours sensitive to docetaxel. In addition, cabazitaxel demonstrates activity in tumour models insensitive to chemotherapy, including docetaxel. At present, data from clinical studies in patients with urothelial cancer is scarce.
    Actual start date of recruitment
    01 Dec 2012
    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
    Netherlands: 5
    Country: Number of subjects enrolled
    Spain: 65
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    34
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included from Spain and The Netherlands. Seventy patients had to be included for the phase II part of the study and, if responses were considered as positive by the Independent Assessment Committee, the study would proceed to phase III. FPI was 12 June 2013. LPI was 29 April 2015.

    Pre-assignment
    Screening details
    		 Random assignment of treatment was stratified by the presence of 0 versus 1 of the following unfavourable prognostic risk factors: - ECOG PS 1. - Anaemia with Hb <10 g/dL. - Presence of liver metastases. Despite 70 patients were included, only 44 were evaluable for response (per protocol population)

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

    Period 1
    Period 1 title
    Baseline period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Study was not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental
    Arm description
    		 Cabazitaxel
    Arm type
    		 Experimental

    Investigational medicinal product name
    cabazitaxel
    Investigational medicinal product code
    XRP6258
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Given intravenously once every 21 days. Cabazitaxel drug products should be administered only by intravenous route. It is supplied as a kit containing one single-use vial of cabazitaxel concentrate for solution for infusion and one single vial of solvent for dilution. The administration of the product requires two dilutions prior to administration. The recommended infusion duration is one hour. The infusion solution should be used within 8 hours at ambient temperature (including the one hour infusion time) or within a total of 48 hours if refrigerated (including the one hour infusion time). The infusion solution should be administered at room temperature under normal lighting conditions. On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour. Cycle length for cabazitaxel is 3 weeks. Patients had to be premedicated accordingly.

    Arm title
    		 Control arm
    Arm description
    		 Vinflunine. Vinflunine is available as a vinflunine 25 mg/ml concentrate for solution for infusion (sterile concentrate). Cycle length for vinflunine is 3 weeks (21 days). Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the ANC as neutropaenia is a frequent AR of vinflunine. New cycles of therapy may not begin until ANC ≥1x109/L, platelet count ≥100x109/L, and non-haematological toxicities (except alopecia) have recovered to baseline. On Day 1 of each cycle, patients will receive vinflunine at a dose of 320 mg/m², administered as a 20 minute intravenous infusion. In case of ECOG PS of 1 or PS of 0 and prior pelvic irradiation, or in patients at least 75 years old but less than 80 years, the treatment should be started at the dose of 280 mg/m². In patients 80 years old and beyond, the dose of vinflunine to be given is 250 mg/m² every 3 weeks. In the absence of any haematological toxicity during the first cycle causing treatment delay or dos
    Arm type
    		 Active comparator

    Investigational medicinal product name
    vinflunine
    Investigational medicinal product code
    Other name
    JAVLOR
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    On Day 1 of each cycle, patients will receive vinflunine at a dose of 320 mg/m², administered as a 20 minute intravenous infusion. In case of ECOG PS of 1 or PS of 0 and prior pelvic irradiation, or in patients at least 75 years old but less than 80 years, the treatment should be started at the dose of 280 mg/m². In patients 80 years old and beyond, the dose of vinflunine to be given is 250 mg/m² every 3 weeks. In the absence of any haematological toxicity during the first cycle causing treatment delay or dose reduction, the dose will be increased to 320 mg/m² every 3 weeks for the subsequent cycles.

    Number of subjects in period 1
    		Experimental Control arm
    Started
    35
    35
    Completed
    35
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline period
    Reporting group description
    		 -

    Reporting group values
    		 Baseline period Total
    Number of subjects
    		 70 70
    Age categorical
    Age was presented as mean and median values. Mean age in the cabazitaxel arm was 62.09 (SD 8.43). Median was 64 years (Q1Q3 56, 68). Min was 42 and Max value 77 years. For the vinflunine arm, mean was 64.29, with SD 9.62; median was 66 years, with Q1, Q3 (59, 70), minimum and maximum values were 35 and 80.
    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)
    		 47 47
        From 65-84 years
    		 23 23
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 65 ( 9.05 ) -
    Gender categorical
    Units: Subjects
        Female
    		 56 56
        Male
    		 14 14
    Subject analysis sets

    Subject analysis set title
    Analysis populations
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT population included all randomized patients. ITT comprised 35 patients per arm, with median age 64 (cabazitaxel) and 66 years (vinflunine arm), with 28 male and 7 female patients at each arm, and comparable baseline charcteristics in weight, height, body surface and vital signs. All randomized patients had received previously one chemotherapy for advanced disease. Previous radiotherapy was reported for 7 patients (cabazitaxel) and 6 patients (vinflunine arm). Prior surgery was reported for 26 patients (cabazitaxel) and 33 (vinflunine arm). Main prior chemotherapy was cisplatin-gemcitabine, despite 6 patients in the cabazitaxel arm and 14 patients in the vinflunine arm had previously received carboplatin-gemcitabine.

    Subject analysis sets values
    		 Analysis populations
    Number of subjects
    70
    Age categorical
    Age was presented as mean and median values. Mean age in the cabazitaxel arm was 62.09 (SD 8.43). Median was 64 years (Q1Q3 56, 68). Min was 42 and Max value 77 years. For the vinflunine arm, mean was 64.29, with SD 9.62; median was 66 years, with Q1, Q3 (59, 70), minimum and maximum values were 35 and 80.
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    47
        From 65-84 years
    23
        85 years and over
    0
    Age continuous
    Units: years
        median (standard deviation)
    65 ( 9.05 )
    Gender categorical
    Units: Subjects
        Female
    56
        Male
    14

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Cabazitaxel

    Reporting group title
    Control arm
    Reporting group description
    		 Vinflunine. Vinflunine is available as a vinflunine 25 mg/ml concentrate for solution for infusion (sterile concentrate). Cycle length for vinflunine is 3 weeks (21 days). Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the ANC as neutropaenia is a frequent AR of vinflunine. New cycles of therapy may not begin until ANC ≥1x109/L, platelet count ≥100x109/L, and non-haematological toxicities (except alopecia) have recovered to baseline. On Day 1 of each cycle, patients will receive vinflunine at a dose of 320 mg/m², administered as a 20 minute intravenous infusion. In case of ECOG PS of 1 or PS of 0 and prior pelvic irradiation, or in patients at least 75 years old but less than 80 years, the treatment should be started at the dose of 280 mg/m². In patients 80 years old and beyond, the dose of vinflunine to be given is 250 mg/m² every 3 weeks. In the absence of any haematological toxicity during the first cycle causing treatment delay or dos

    Subject analysis set title
    Analysis populations
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT population included all randomized patients. ITT comprised 35 patients per arm, with median age 64 (cabazitaxel) and 66 years (vinflunine arm), with 28 male and 7 female patients at each arm, and comparable baseline charcteristics in weight, height, body surface and vital signs. All randomized patients had received previously one chemotherapy for advanced disease. Previous radiotherapy was reported for 7 patients (cabazitaxel) and 6 patients (vinflunine arm). Prior surgery was reported for 26 patients (cabazitaxel) and 33 (vinflunine arm). Main prior chemotherapy was cisplatin-gemcitabine, despite 6 patients in the cabazitaxel arm and 14 patients in the vinflunine arm had previously received carboplatin-gemcitabine.

    Primary: change in response rate

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    End point title
    		 change in response rate
    End point description
    The ORR and best overall responses were analyzed taking into account RECIST 1.1 criteria. There were 4 patients with partial response in the cabazitaxel arm and 8 patients with partial response in the vinflunine arm.
    End point type
    Primary
    End point timeframe
    Responses were collected until each patient developed progressive disease
    End point values
    		 Experimental Control arm Analysis populations
    Number of subjects analysed
    35 [1]
    35 [2]
    70 [3]
    Units: number of partial and complete responses
        Partial Response
    4
    8
    12
        Complete Response
    0
    0
    0
        Stable disease
    11
    14
    25
        Progressive disease
    15
    11
    26
    Notes
    [1] - Cabazitaxel arm
    [2] - Vinflunine arm
    [3] - ITT population
    Statistical analysis title
    		 Progression free survival
    Statistical analysis description
    PFs was defined as the time from randomization date to objective tumor progression or death
    Comparison groups
    Experimental v Control arm v Analysis populations
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    P-value
    		 < 0.05 [5]
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.0931
         upper limit
    		 3.165
    Variability estimate
    Standard deviation
    Notes
    [4] - Number of patients with event was 32 for the cabazitaxel arm versus 29 for the vinflunine arm. Median PFS was 1.78 months for the cabazitaxel arm versus 2.89 for the vinflunine arm.
    [5] - p was 0.0221

    Secondary: change in PFS

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    End point title
    		 change in PFS
    End point description
    Median PFS was 1.78 months for cabazitaxel versus 2.89 months for vinflunine
    End point type
    Secondary
    End point timeframe
    time from randomization till death or progressive disease
    End point values
    		 Experimental Control arm Analysis populations
    Number of subjects analysed
    35 [6]
    35 [7]
    35 [8]
    Units: months
    median (confidence interval 95%)
        dead
    1.78 (1.35 to 4.34)
    2.89 (1.45 to 8.68)
    1.78 (1.35 to 4.34)
        alive
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [6] - cabazitaxel arm
    [7] - vinflunine arm
    [8] - cabazitaxel arm
    No statistical analyses for this end point

    Secondary: Change in OS

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    End point title
    		 Change in OS
    End point description
    Overall survival(OS), is defined as the time from randomization date to death date, due to any cause. For the OS analysis, patients who were lost to follow-up were censored at the date of last contact.
    End point type
    Secondary
    End point timeframe
    From randomization to death
    End point values
    		 Experimental Control arm Analysis populations
    Number of subjects analysed
    35 [9]
    35 [10]
    Units: months
        median (confidence interval 95%)
    5.49 (3.65 to 11.74)
    8.35 (5.03 to 13.87)
    5.49 (3.65 to 11.74)
    Notes
    [9] - cabazitaxel arm
    [10] - vinflunine arm
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization date to the last contact date
    Adverse event reporting additional description
    Median follow up time was 13.81 months for cazabitaxel versus 17.88 months for vinflunine arm
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 All exposed subjects

    Reporting group title
    cabazitaxel
    Reporting group description
    		 Patients in cabazitaxel arm

    Reporting group title
    vinflunine arm
    Reporting group description
    		 Patients on vinflunine arm

    Serious adverse events
    		 Safety population cabazitaxel vinflunine arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 70 (54.29%)
    20 / 35 (57.14%)
    18 / 35 (51.43%)
         number of deaths (all causes)
    4
    4
    0
         number of deaths resulting from adverse events
    4
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    tumor pain back
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    fever
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    malaise
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    disease progression
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    general malaise
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    clinical deterioration
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    pain pelvis
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    respiratory insuficience
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COPD worsening
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    opioid intoxication
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    flutter auricular
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    paroximal supraventricular tachycardia
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    myocard infarction
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Nervous system disorders
    low extremities muscle weakness
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    myelum compression
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    low awareness level due to progression brain disease
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    afebrile neutropenia
         subjects affected / exposed
    5 / 70 (7.14%)
    0 / 35 (0.00%)
    5 / 35 (14.29%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    febrile neutropenia
         subjects affected / exposed
    7 / 70 (10.00%)
    3 / 35 (8.57%)
    4 / 35 (11.43%)
         occurrences causally related to treatment / all
    7 / 7
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    4 / 70 (5.71%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
    Additional description: Constipation occurred in 24 patients in vinflunine arm
         subjects affected / exposed
    4 / 70 (5.71%)
    0 / 35 (0.00%)
    4 / 35 (11.43%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diarrhea
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intestinal suboclusion
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intestinal suboclussion
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    hematuria
         subjects affected / exposed
    2 / 70 (2.86%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    renal failure
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    acute kidney failure
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    pain in left lower extremity
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    uncontrolled bone pain
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    respiratory infection
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urinary infection
         subjects affected / exposed
    4 / 70 (5.71%)
    4 / 35 (11.43%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urinary sepsis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    erysipelas
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    abscess
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    wound infection
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    neutropenia urosepsis
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    hyponatremia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Safety population cabazitaxel vinflunine arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 70 (100.00%)
    35 / 35 (100.00%)
    35 / 35 (100.00%)
    General disorders and administration site conditions
    decreased apetite
         subjects affected / exposed
    23 / 70 (32.86%)
    11 / 35 (31.43%)
    12 / 35 (34.29%)
         occurrences all number
    23
    11
    12
    fatigue
         subjects affected / exposed
    25 / 70 (35.71%)
    11 / 35 (31.43%)
    14 / 35 (40.00%)
         occurrences all number
    25
    11
    14
    asthenia
         subjects affected / exposed
    22 / 70 (31.43%)
    8 / 35 (22.86%)
    14 / 35 (40.00%)
         occurrences all number
    22
    8
    14
    pyrexia
         subjects affected / exposed
    18 / 70 (25.71%)
    8 / 35 (22.86%)
    10 / 35 (28.57%)
         occurrences all number
    18
    8
    10
    febrile neutropenia
         subjects affected / exposed
    10 / 70 (14.29%)
    7 / 35 (20.00%)
    3 / 35 (8.57%)
         occurrences all number
    10
    7
    3
    Blood and lymphatic system disorders
    neutropenia
         subjects affected / exposed
    13 / 70 (18.57%)
    5 / 35 (14.29%)
    8 / 35 (22.86%)
         occurrences all number
    13
    5
    8
    anemia
         subjects affected / exposed
    12 / 70 (17.14%)
    9 / 35 (25.71%)
    3 / 35 (8.57%)
         occurrences all number
    12
    9
    3
    Gastrointestinal disorders
    Constipation
    Additional description: 30 patients had constipation, 6 in cabazitaxel arm and 24 in vinflunine arm
         subjects affected / exposed
    70 / 70 (100.00%)
    35 / 35 (100.00%)
    35 / 35 (100.00%)
         occurrences all number
    70
    35
    35
    nausea
         subjects affected / exposed
    23 / 70 (32.86%)
    7 / 35 (20.00%)
    16 / 35 (45.71%)
         occurrences all number
    23
    7
    16
    diarrhea
         subjects affected / exposed
    18 / 70 (25.71%)
    13 / 35 (37.14%)
    5 / 35 (14.29%)
         occurrences all number
    18
    13
    5
    vomiting
         subjects affected / exposed
    11 / 70 (15.71%)
    4 / 35 (11.43%)
    7 / 35 (20.00%)
         occurrences all number
    11
    4
    7
    mucosal inflammation
         subjects affected / exposed
    9 / 70 (12.86%)
    2 / 35 (5.71%)
    7 / 35 (20.00%)
         occurrences all number
    9
    2
    7
    Alopecia
         subjects affected / exposed
    8 / 70 (11.43%)
    3 / 35 (8.57%)
    5 / 35 (14.29%)
         occurrences all number
    8
    3
    5
    Abdominal pain
         subjects affected / exposed
    8 / 70 (11.43%)
    2 / 35 (5.71%)
    6 / 35 (17.14%)
         occurrences all number
    8
    2
    6
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    6 / 70 (8.57%)
    1 / 35 (2.86%)
    5 / 35 (14.29%)
         occurrences all number
    6
    1
    5
    dyspnea
         subjects affected / exposed
    6 / 70 (8.57%)
    2 / 35 (5.71%)
    4 / 35 (11.43%)
         occurrences all number
    6
    2
    4
    Renal and urinary disorders
    urinary tract infection
         subjects affected / exposed
    12 / 70 (17.14%)
    9 / 35 (25.71%)
    3 / 35 (8.57%)
         occurrences all number
    12
    9
    3
    Musculoskeletal and connective tissue disorders
    back pain
         subjects affected / exposed
    8 / 70 (11.43%)
    5 / 35 (14.29%)
    3 / 35 (8.57%)
         occurrences all number
    8
    5
    3
    Musculoskeletal pain
         subjects affected / exposed
    7 / 70 (10.00%)
    4 / 35 (11.43%)
    3 / 35 (8.57%)
         occurrences all number
    7
    4
    3
    myalgia
         subjects affected / exposed
    6 / 70 (8.57%)
    0 / 35 (0.00%)
    6 / 35 (17.14%)
         occurrences all number
    6
    0
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2013
    Amendment 1
    03 Sep 2014
    Amendment 2
    30 Nov 2015
    Amendment 3

    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.
    Study was finished after phase II part showed that cabazitaxel was not better than vinflunine in terms of ORR and PFS

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28419193
    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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