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    Clinical Trial Results:
    Randomized phase II trial of cabazitaxel or prolonged infusional ifosfamide in metastatic or inoperable locally advanced dedifferentiated liposarcoma

    Summary
    EudraCT number
    		 2012-003672-39
    Trial protocol
    		 BE   GB   FR   IT   NL  
    Global end of trial date
    02 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1202-STBSG
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01913652
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    European Organisation for the Research and Treatment of Cancer (EORTC)
    Sponsor organisation address
    Avenue E. Mounierlaan 83/11, Brussels, Belgium, 1200
    Public contact
    Head Project Management &Regulatory, European Organaisation for Research and Treatment of Cancer (EORTC), +32 27741044, regulatory@eortc.be
    Scientific contact
    Head Project Management &Regulatory, European Organaisation for Research and Treatment of Cancer (EORTC), +32 27741044, regulatory@eortc.be
    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
    17 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient antitumor activity (as measured by progression free survival at 12 weeks) in patients with metastatic or inoperable locally advanced dedifferentiated (DD) liposarcoma to justify further investigation of the efficacy of these treatment options in a phase III setting.
    Protection of trial subjects
    The responsible investigator ensured that this study was conducted in agreement with either the Declaration of Helsinki (available on the World Medical Association web site (http://www.wma.net)) and/or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol had been written, and the study was conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice (ICH-GCP, available online at http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf). The protocol was approved by the competent ethics committee(s) as required by the applicable national legislation.
    Background therapy
    		 Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Italy: 18
    Worldwide total number of subjects
    40
    EEA total number of subjects
    29
    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)
    18
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 40 patients were registered by 10 institutions in 4 countries between 26th March 2015 and 4th March 2019. After review, 2 patients were found not eligible for this trial (one diagnosis of DD liposarcoma not confirmed and the other with an unstable medical condition).

    Pre-assignment
    Screening details
    		 --Metastatic or inoperable locally advanced dedifferentiated liposarcoma -Age 18-75 yrs -WHO performance status 0-1 -One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma -Adequate haematological, renal and hepatic function

    Pre-assignment period milestones
    Number of subjects started
    		 40
    Number of subjects completed
    		 40

    Period 1
    Period 1 title
    Overall period - Full patient population
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cabazitaxel
    Arm description
    		 • Cabazitaxel 25mg/m² IV infusion over 1 hour every 21 days. • The day of first treatment is defined as day 1 of cycle 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infusion
    Dosage and administration details
    Cabazitaxel will be administered at a dose of 25 mg/m² by intravenous infusion, over 1 hour, on day 1 of each 21 day cycle. Treatment should be administered until disease progression, unacceptable toxicity or patient's refusal.

    Number of subjects in period 1
    		Cabazitaxel
    Started
    40
    Completed
    0
    Not completed
    40
         Clinical progression
    2
         Patient decision
    2
         Physician decision
    2
         Start of new anti-cancer treatment
    1
         Disease progression
    22
         Still on treatment at analysis
    1
         Toxicity
    9
         Unconfirmed PD related death
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period - Full patient population
    Reporting group description
    		 Forty patients (40) were enrolled into this trials, amongst whom 2 patients were found not eligible after review (one diagnosis of DD liposarcoma not confirmed and the other with an unstable medical condition).

    Reporting group values
    		 Overall period - Full patient population Total
    Number of subjects
    		 40 40
    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)
    		 18 18
        From 65-84 years
    		 22 22
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.03 ( 9.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 21 21
    Grade
    Units: Subjects
        Grade I
    		 1 1
        Grade II
    		 33 33
        Grade III
    		 6 6
    WHO performance status
    Units: Subjects
        PS 0
    		 22 22
        PS 1
    		 18 18
    Tumor differentiation
    Units: Subjects
        High
    		 1 1
        Moderate
    		 2 2
        Poor/undifferentiated
    		 37 37
    Concomitant non-malignant disease
    Units: Subjects
        No
    		 8 8
        Yes
    		 32 32
    Subject analysis sets

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Among the 40 patients that were enrolled, after review, 2 patients were found not eligible for this trial (one diagnosis of DD liposarcoma not confirmed and the other with an unstable medical condition). Thus, this reporting subgroup consist of the 38 eligible patients that were enrolled and started treatment.

    Subject analysis set title
    Final decision rule population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The first 37 patients who are eligible and have started their allocated treatment (at least one dose of the study drug). The Simon two-stage design was applied, 17 (stage 1) or 37 (stage 2) eligible and treated patients were required. In stage 2, if 11 or more successes are observed in those 37 patients, we will conclude that the results of this trial warrant further investigation of the drug in this disease. Note that the minimum number of successes needed in stage 1 to continue to stage 2 was achieved (i.e. at least 4 out of 17).

    Subject analysis sets values
    		 Per protocol population Final decision rule population
    Number of subjects
    38
    37
    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)
    18
    17
        From 65-84 years
    20
    20
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.71 ( 9.71 )
    62.81 ( 9.82 )
    Gender categorical
    Units: Subjects
        Female
    18
    17
        Male
    20
    20
    Grade
    Units: Subjects
        Grade I
    0
    0
        Grade II
    32
    31
        Grade III
    6
    6
    WHO performance status
    Units: Subjects
        PS 0
    21
    21
        PS 1
    17
    16
    Tumor differentiation
    Units: Subjects
        High
    0
    0
        Moderate
    2
    2
        Poor/undifferentiated
    36
    35
    Concomitant non-malignant disease
    Units: Subjects
        No
    8
    8
        Yes
    30
    29

    End points

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    End points reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    		 • Cabazitaxel 25mg/m² IV infusion over 1 hour every 21 days. • The day of first treatment is defined as day 1 of cycle 1.

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Among the 40 patients that were enrolled, after review, 2 patients were found not eligible for this trial (one diagnosis of DD liposarcoma not confirmed and the other with an unstable medical condition). Thus, this reporting subgroup consist of the 38 eligible patients that were enrolled and started treatment.

    Subject analysis set title
    Final decision rule population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The first 37 patients who are eligible and have started their allocated treatment (at least one dose of the study drug). The Simon two-stage design was applied, 17 (stage 1) or 37 (stage 2) eligible and treated patients were required. In stage 2, if 11 or more successes are observed in those 37 patients, we will conclude that the results of this trial warrant further investigation of the drug in this disease. Note that the minimum number of successes needed in stage 1 to continue to stage 2 was achieved (i.e. at least 4 out of 17).

    Primary: Progression free survival(PFS) at 12 weeks

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    End point title
    		 Progression free survival(PFS) at 12 weeks
    End point description
    Progression free survival at 12 weeks is measured as a binary variable, based on the locally assessed disease evaluation performed 12 weeks after start of treatment. Patients will be considered as "success" if this assessment indicates "stable disease" or a "response" as defined by RECIST v1.1. All other cases will be considered as failures (including patients who have progressed, symptomatically deteriorated or died before the 12 week evaluation, patients with an unknown progression status at 12 weeks, or patients who started new anti-tumor therapy in the absence of progressive disease).
    End point type
    Primary
    End point timeframe
    PFS (binary) performed 12 weeks after start of treatment.
    End point values
    		 Per protocol population Final decision rule population
    Number of subjects analysed
    38
    37
    Units: Subjects
        Success
    21
    21
        Failure
    17
    16
    Statistical analysis title
    		 Primary endpoint- Simon optimal two-stage design
    Statistical analysis description
    The Simon optimal two-stage design was used, with the following hypotheses : P0 was taken as 20% - success in 20% of the cases was considered as unacceptable, and would not warrant further investigation. P1 was taken as 40% - success in 40% of the cases was considered as an acceptable result warranting further investigation of the drug in this histology. Type I error and type II error are fixed at 10%. Under these hypotheses, a total of 37 eligible and treated patients were needed.
    Comparison groups
    Per protocol population v Final decision rule population
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.001 [2]
    Method
    		 proportion, conditional 1-sided 95% CI
    Parameter type
    		 binomial proportion
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.408
         upper limit
    		 -
    Notes
    [1] - Progression free survival at 12 weeks after start of treatment was taken as a binary indicator of success or failure and was reported as a proportion with a conditional 95% confidence interval as recommended by Koyama and Chen (Stat Med. 2008). This is a single arm test - two arms were provided due to EUDRACT reporting system limitation. The primary test is performed in the final decision rule population only.
    [2] - Conditional p-value as recommended by Koyama and Chen (Stat Med. 2008).

    Secondary: Response at 12 weeks -Local investigator

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    End point title
    		 Response at 12 weeks -Local investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Based on the locally assessed disease evaluation performed 12 weeks after start of treatment.
    End point values
    		 Per protocol population Final decision rule population
    Number of subjects analysed
    38
    37
    Units: Subjects
        Stable
    21
    21
        Progression
    12
    11
        Early death
    1
    1
        Not evaluable
    4
    4
    No statistical analyses for this end point

    Secondary: PFS at 12 weeks (binary)-Central review

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    End point title
    		 PFS at 12 weeks (binary)-Central review
    End point description
    End point type
    Secondary
    End point timeframe
    Based on disease evaluation (as defined by RECIST v1.1) performed 12 weeks after start of treatment via central review.
    End point values
    		 Per protocol population
    Number of subjects analysed
    38
    Units: Subjects
        Success
    16
        Failure
    22
    No statistical analyses for this end point

    Secondary: Response at 12 weeks-Central review

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    End point title
    		 Response at 12 weeks-Central review
    End point description
    End point type
    Secondary
    End point timeframe
    Based on disease evaluation (as defined by RECIST v1.1) performed 12 weeks after start of treatment via central review.
    End point values
    		 Per protocol population
    Number of subjects analysed
    Units: Subjects
        Stable
    16
        Progression
    5
        Early death
    1
        Not evaluable
    16
    No statistical analyses for this end point

    Secondary: Progression free survival (PFS)-Local investigator

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    End point title
    		 Progression free survival (PFS)-Local investigator
    End point description
    Progression free survival was computed from the date of start of treatment to the first documented date of progression (according to RECIST v1.1 as assessed by local reviewer) or death, whatever the cause, whichever occurs first. Patients alive and free from progression at the time of the analysis will be censored at the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    PFS was computed from the date of start of treatment to the first documented date of progression (according to RECIST v1.1) or death, whatever the cause, whichever occurs first.
    End point values
    		 Cabazitaxel Per protocol population
    Number of subjects analysed
    40
    38
    Units: Months
        median (confidence interval 95%)
    6.5 (2.8 to 10.3)
    6.5 (2.8 to 10.3)
    Statistical analysis title
    		 PFS- Per protocol population
    Statistical analysis description
    Progression free survival will be computed from the date of start of treatment to the first documented date of progression (according to RECIST v1.1) or death, whatever the cause, whichever occurs first. Patients alive and free from progression at the time of the analysis will be censored at the date of last follow-up. PFS was estimated by the Kaplan-Meier (KM) method. Median PFS was provided with its 95% confidence interval.
    Comparison groups
    Cabazitaxel v Per protocol population
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Kaplan-Meier
    Parameter type
    		 Median PFS estimate
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 10.3
    Notes
    [3] - This is a single arm assessment and PFS was performed only in the per protocol population. Two arms were provided due to EUDRACT reporting system limitation.

    Secondary: PFS-Central review

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    End point title
    		 PFS-Central review
    End point description
    Progression free survival was computed from the date of start of treatment to the first documented date of progression (according to RECIST v1.1 as assessed by central reviewer) or death, whatever the cause, whichever occurs first. Patients alive and free from progression at the time of the analysis will be censored at the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    Progression free survival was computed from the date of start of treatment to the first documented date of progression or death, whatever the cause, whichever occurs first.
    End point values
    		 Cabazitaxel Per protocol population
    Number of subjects analysed
    40 [4]
    38 [5]
    Units: Months
        median (confidence interval 95%)
    8.3 (2.8 to 10.7)
    8.3 (2.8 to 10.7)
    Notes
    [4] - This is a single arm test - two arms were provided due to EUDRACT reporting system limitation
    [5] - This analysis was only performed in the per protocol population
    Statistical analysis title
    		 PFS - Per protocol population (Central review)
    Comparison groups
    Cabazitaxel v Per protocol population
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Kaplan-Meier
    Parameter type
    		 Median PFS estimate
    Point estimate
    8.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 10.7

    Secondary: Time to progression (TTP)

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    End point title
    		 Time to progression (TTP)
    End point description
    Time to progression was computed from the date of start of treatment to the first documented date of progression (measured according to the RECIST v1.1 , as assess by local reviewers) or death due to progressive disease, whichever occurs first. Patients free from progression at the time of analysis were censored at the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    TTP was computed from the date of start of treatment to the first documented date of progression (measured according to the RECIST v1.1, as assess by local reviewers) or death due to progressive disease, whichever occurs first.
    End point values
    		 Cabazitaxel Per protocol population
    Number of subjects analysed
    40 [6]
    38 [7]
    Units: Months
        median (confidence interval 95%)
    7.4 (2.8 to 12.1)
    7.4 (2.8 to 12.1)
    Notes
    [6] - This is a single arm assessment. Two arms were provided due to EUDRACT reporting system limitation.
    [7] - This is a single arm assessment and TTP was performed only in the per protocol population.
    Statistical analysis title
    		 TTP- Per protocol population
    Statistical analysis description
    Time to progression (TTP) was computed from the date of start of treatment to the first documented date of progression or death due to progressive disease, whichever occurs first. Patients free from progression at the time of analysis will be censored at the date of last follow-up. TTP was estimated by the Kaplan-Meier (KM) method. Median TTP was provided with its 95% confidence interval.
    Comparison groups
    Cabazitaxel v Per protocol population
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Median TTP estimate
    Point estimate
    7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 12.1
    Notes
    [8] - This is a single arm assessment. TTP was performed only in the per protocol population. Two arms were provided due to EUDRACT reporting system limitation.

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival (OS) was computed from the date of start of treatment to the date of death (due to any cause). Patients alive at the time of analysis will be censored at the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    OS was computed from the date of start of treatment to the date of death (due to any cause).
    End point values
    		 Cabazitaxel Per protocol population
    Number of subjects analysed
    40 [9]
    38 [10]
    Units: Months
        median (confidence interval 95%)
    21.1 (14.8 to 33.5)
    21.1 (14.8 to 33.5)
    Notes
    [9] - This is a single arm assessment. Two arms were provided due to EUDRACT reporting system limitation.
    [10] - This is a single arm assessment and OS analysis was performed only in the per protocol population.
    Statistical analysis title
    		 OS- Per protocol population
    Statistical analysis description
    Overall survival (OS) was computed from the date of start of treatment to the date of death (due to any cause). Patients alive at the time of analysis were censored at the date of last follow-up. OS was estimated by the Kaplan-Meier (KM) method. Median PFS was provided with its 95% confidence interval.
    Comparison groups
    Cabazitaxel v Per protocol population
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    		 Kaplan-Meier
    Parameter type
    		 Median OS estimate
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.8
         upper limit
    		 33.5
    Notes
    [11] - This is a single arm assessment and OS was performed only in the per protocol population. Two arms were provided due to EUDRACT reporting system limitation

    Secondary: Objective tumor response (Local investigator)

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    End point title
    		 Objective tumor response (Local investigator)
    End point description
    Objective tumor response (CR + PR) was measured according to RECIST v1.1(by local investigators). Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and – together with other lesions that are denoted as non-target lesions – followed until disease progression. Each patient will be assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death or not evaluable.
    End point type
    Secondary
    End point timeframe
    Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and –together with other lesions that are denoted as non-target lesions – followed until disease progression.
    End point values
    		 Cabazitaxel Per protocol population
    Number of subjects analysed
    40 [12]
    38 [13]
    Units: Subjects
        No
    35
    35
        Yes
    3
    3
    Notes
    [12] - This is a single arm study. Objective tumor response was assessed in the per-protocol population
    [13] - Objective tumor response was only assessed in the per-protocol population
    Statistical analysis title
    		 Objective response (CR+PR)
    Statistical analysis description
    The rate of objective tumor response (CR+PR) was computed with its 95% confidence interval (from the exact binomial distribution). Patients in response categories progression, early death or unknown were considered as failures.
    Comparison groups
    Cabazitaxel v Per protocol population
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    		 exact binomial
    Parameter type
    		 proportion estimate
    Point estimate
    7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 21.4
    Notes
    [14] - This is a single arm assessment. The rate of objective tumor response (CR+PR)was performed only in the per protocol population. Two arms were provided due to EUDRACT reporting system limitation.

    Secondary: Best overall response (Local investigator)

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    End point title
    		 Best overall response (Local investigator)
    End point description
    Response was measured according to RECIST v1.1 (performed by local investigator). Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and – together with other lesions that are denoted as non-target lesions – followed until disease progression. Each patient was assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death or not evaluable.
    End point type
    Secondary
    End point timeframe
    Patients' best overall response was based on assessments from start of treatment until the end of treatment or until clinical cut-off for this analysis ( for patients still on treatment).
    End point values
    		 Per protocol population
    Number of subjects analysed
    38
    Units: Subjects
        Complete response
    1
        Partial response
    2
        Stable disease
    22
        Progressive disease
    11
        Early death
    1
        Not evaluable
    1
    No statistical analyses for this end point

    Secondary: Objective tumor response (Central review)

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    End point title
    		 Objective tumor response (Central review)
    End point description
    Objective tumor response (CR + PR) was measured according to RECIST v1.1 (via central review). Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and – together with other lesions that are denoted as non-target lesions – followed until disease progression. Each patient will be assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death or not evaluable.
    End point type
    Secondary
    End point timeframe
    Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and –together with other lesions that are denoted as non-target lesions – followed until disease progression.
    End point values
    		 Per protocol population
    Number of subjects analysed
    38
    Units: Subjects
        No
    36
        Yes
    2
    No statistical analyses for this end point

    Secondary: Best overall response (Central review)

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    End point title
    		 Best overall response (Central review)
    End point description
    Response was measured according to RECIST v1.1 (central review). Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and – together with other lesions that are denoted as non-target lesions – followed until disease progression. Each patient was assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death or not evaluable.
    End point type
    Secondary
    End point timeframe
    Patients' best overall response was based on assessments from start of treatment until the end of treatment or until clinical cut-off for this analysis ( for patients still on treatment).
    End point values
    		 Per protocol population
    Number of subjects analysed
    38
    Units: Subjects
        Complete response
    0
        Partial response
    2
        Stable disease
    20
        Progressive disease
    10
        Early death
    1
        Not evaluable
    5
    No statistical analyses for this end point

    Secondary: Time to onset of response

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    End point title
    		 Time to onset of response
    End point description
    At the time of clinical cut-off for this analysis, objective response (CR/PR) was observed in 3 out of the 38 eligible patients.
    End point type
    Secondary
    End point timeframe
    Time to onset of response was measured from the date of start of treatment until the criteria for CR/PR (whichever is first recorded) are met.
    End point values
    		 Per protocol population
    Number of subjects analysed
    38
    Units: Months
        median (full range (min-max))
    8 (5.1 to 8.3)
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    Only one of the three eligible patients who experience objective response had progressed at the time of clinical cut-off for this analysis.
    End point type
    Secondary
    End point timeframe
    Response duration will be measured from the time measurement criteria for CR/PR (whichever is first recorded) are first met until the first date that progressive disease is objectively documented.
    End point values
    		 Per protocol population
    Number of subjects analysed
    38
    Units: Months
        number (not applicable)
    2.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events, laboratory and physical abnormalities were collected till three months after the end of treatment. Afterwards, only treatment related AE are collected. For SAEs: all SAEs till 30 days after end of treatment; afterwards, only related SAEs
    Adverse event reporting additional description
    CRF for AEs contains pre-specified items + additional boxes for all "other" AEs. AEs are evaluated using CTC grading, SAEs using MedDra. AEs are tabulated for safety population, i.e. all patients starting Cabazitaxel.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 This was based on the safety population, i.e. all 40 patients who started Cabazitaxel

    Serious adverse events
    		 Arm 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 40 (35.00%)
         number of deaths (all causes)
    21
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    INFUSION RELATED REACTION
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    FEBRILE NEUTROPENIA
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    NEUTROPENIA
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    CONDITION AGGRAVATED
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    FATIGUE
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PAIN
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PYREXIA
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COLITIS
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    DIARRHOEA
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    INTESTINAL OBSTRUCTION
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NAUSEA
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    VOMITING
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    URINARY RETENTION
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    ENTEROCOLITIS INFECTIOUS
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ERYSIPELAS
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 40 (95.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    TUMOR PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Vascular disorders
    FLUSHING
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    THROMBOEMBOLIC EVENT
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    EDEMA LIMBS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    FATIGUE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    19 / 40 (47.50%)
         occurrences all number
    37
    FEVER
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    8
    FLU LIKE SYMPTOMS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    INFUSION RELATED REACTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    5
    INJECTION SITE REACTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    MALAISE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    NON-CARDIAC CHEST PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    6
    Reproductive system and breast disorders
    VAGINAL DISCHARGE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    DYSPNEA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    EPISTAXIS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    POSTNASAL DRIP
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Psychiatric disorders
    ANXIETY
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    DEPRESSION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    INSOMNIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    5
    ALKALINE PHOSPHATASE INCREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    BLOOD BILIRUBIN INCREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    CREATININE INCREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    LYMPHOCYTE COUNT DECREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    8
    NEUTROPHIL COUNT DECREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    21 / 40 (52.50%)
         occurrences all number
    42
    PLATELET COUNT DECREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    7
    WEIGHT GAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    WHITE BLOOD CELL DECREASED
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    13
    WEIGHT LOSS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    11 / 40 (27.50%)
         occurrences all number
    17
    Injury, poisoning and procedural complications
    FRACTURE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Cardiac disorders
    MYOCARDITIS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    SINUS TACHYCARDIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Nervous system disorders
    CONCENTRATION IMPAIRMENT
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    DIZZINESS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    DYSGEUSIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    8
    HEADACHE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    NEURALGIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    PERIPHERAL MOTOR NEUROPATHY
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    PERIPHERAL SENSORY NEUROPATHY
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    ANEMIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    12 / 40 (30.00%)
         occurrences all number
    42
    FEBRILE NEUTROPENIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    10 / 40 (25.00%)
         occurrences all number
    11
    Eye disorders
    CONJUNCTIVITIS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    BLOATING
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    ABDOMINAL DISTENSION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    ABDOMINAL PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    9
    COLITIS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    CONSTIPATION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    DIARRHEA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    17 / 40 (42.50%)
         occurrences all number
    31
    DYSPEPSIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    6
    DYSPHAGIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    FLATULENCE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    GASTROESOPHAGEAL REFLUX DISEASE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    HEMORRHOIDS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    MUCOSITIS ORAL
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    NAUSEA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    17 / 40 (42.50%)
         occurrences all number
    24
    STOMACH PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    VOMITING
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    ALOPECIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    DRY SKIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    PRURITUS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    NAIL RIDGING
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    RASH MACULO-PAPULAR
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    Renal and urinary disorders
    CHRONIC KIDNEY DISEASE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    CYSTITIS NONINFECTIVE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    HEMATURIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    URINARY RETENTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    URINARY TRACT PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    5
    CHEST WALL PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    BACK PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    FLANK PAIN
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    3
    MYALGIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    PAIN IN EXTREMITY
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Infections and infestations
    BLADDER INFECTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    CATHETER RELATED INFECTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    5
    RHINITIS INFECTIVE
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    ENTEROCOLITIS INFECTIOUS
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    SKIN INFECTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    SMALL INTESTINE INFECTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    UPPER RESPIRATORY INFECTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    URINARY TRACT INFECTION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    ANOREXIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    13 / 40 (32.50%)
         occurrences all number
    16
    HYPOALBUMINEMIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    5
    DEHYDRATION
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    HYPOKALEMIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    HYPOMAGNESEMIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    HYPOPHOSPHATEMIA
    alternative dictionary used: CTCAE 4.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2015
    This study was originally designed to evaluate two different chemotherapy regimes in second line, in two independent Simon 2-stage phase II trials run in parallel, one addressing cabazitaxel, the other addressing prolonged infusional ifosfamide (described in previous versions 1.0 and 2.0 of the protocol). On the 05/03/2015 there was a protocol amendment (1.0 to 2.0), and the rationale for the amendment and its classification were: Upon the release of the Investigator’s brochure for Cabazitaxel, the patient information sheet had to be amended for side effects. In addition, the protocol was updated for the following sections: • Background section : new information from Cabazitaxel’s IB • Eligibility section based on German Ethics committee request • Drug information section: information about Baxter pump (pharmacy Royal Marsden), capping the dose for ifosfamide to a maximum of Body Surface Area of 2 m² (request study coordinator), new data about drug-drug interactions (Cabazitaxel’s IB). • End of study definition (Section 8.4) to ensure the safety reporting of all patients while on treatment • List of Reference pathologists (Pathologist reviewer added for German sites, and changed for Italy [from the UK to the French lab]).
    26 Oct 2016
    Recruitment issues led to a further amendment. On the 26/10/2016, the EORTC Board decided to move on with a phase 2 design with single agent cabazitaxel. They suspected that the amended protocol would attract more patients than had been the case before. The protocol (current version 3.0) was amended as well as the patient information sheet to remove the ifosfamide arm. In addition, changes have been implemented: • Changes to eligibility criteria based upon study coordinator ‘s suggestions and based on the current reference safety document : • Age 18-75 years old • Hepatic: Bilirubin < 1.5 times upper limit of normal (1.5xULN) of institutional limits, ALT and/or AST< 1.5 x ULN. If isolated elevated bilirubin <2 x ULN and Gilberts syndrome suspected, suggest repeating bloods after food. If bilirubin improves to meet the criteria above this is acceptable. • Renal: creatinine clearance (CrCl) * > 30 ml/min; • No inflammation of the urinary bladder (cystitis); • Change to adverse events/ side-effects associated with the drugs based on the current reference safety document. • Phase 2 design with single agent cabazitaxel o All reference to ifosfamide removed o All references to randomization removed or changed appropriately (eg. registration) o All references to recruited removed or changed appropriately (eg. screened) o Removal of the Stratification factors, o Plural reference to treatment or arms changed to singular etc • Change in number of subjects planned for trial and for each participating country due to a change in design. o Up to 50 patients will be enrolled. • Change in duration of trial o At the time of submission of the amendment (v3.0) to the protocol, 1 patient had started treatment o The duration of accrual was expected to vary between 10 months and 20 months (30-40 months from first patient in (FPI)). • Changes to reporting procedures and FU of SAEs

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

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