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    Clinical Trial Results:
    Personalized treatment of metastatic Castrate-resistant prostate cancer patients according to circulating tumor cells kinetic during chemotherapy

    Summary
    EudraCT number
    		 2016-002429-12
    Trial protocol
    		 FR  
    Global end of trial date
    26 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2025
    First version publication date
    07 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UC_0160/1613
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03101046
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75015
    Public contact
    Nourredine AIT RAHMOUNE, UNICANCER, 33 0171936704, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT RAHMOUNE, UNICANCER, 33 0171936704, n.ait-rahmoune@unicancer.fr
    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
    05 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCPRC defined as ≥ 5CTCs/7.5ml after 2 cycles of docetaxel.
    Protection of trial subjects
    This study was conducted in compliance with the protocol described in Section 16.1.1, and in accordance with the French national regulatory requirements: - Loi n°2012-300 du 5 mars 2012 (dite loi "Jardé ") relative aux recherches impliquant la personne humaine, - Loi Informatique et Libertés n° 78-17 du 6 janvier 1978 modifiée, relative à la protection des personnes physiques à l'égard des traitements de données à caractère personnel, - Loi n° 2004-800 du 6 août 2004 modifiée, relative à la bioéthique, - Décision portant sur les Bonnes Pratiques Cliniques du 24 novembre 2006, - Bonnes Pratiques de Fabrication en vigueur, notamment la ligne directrice 13, relative aux médicaments expérimentaux. - Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Mar 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    9
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 12 centres randomized 40 patients between March 08th, 2019 and October 14th, 2020, a period of inclusion of 19.3 months.

    Pre-assignment
    Screening details
    		 After signature of the consent form and assessment of the eligibility criteria, blood samples were collected from eligible patients. CTCs were enumerated using the CellSearch System (CTC count screening). Patients with unfavorable CTC count at screening defined as ≥ 5 CTC/7.5 mL were enrolled in the study.

    Period 1
    Period 1 title
    Overall periode
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group I: Cohort
    Arm description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel sensitive (<5 CTCs/7.5 mL) after 2 cycles of docetaxel. The patients will receive 6 additional cycles of docetaxel..
    Arm type
    		 Standard treatment arm and cohort

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel is administered at the dose of 75 mg/m² over 1 hour every 3 weeks for 6 cycles (D1=D22).

    Arm title
    		 Group II: Arm A
    Arm description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel resistant (≥ 5 CTCs/7.5 mL) after 2 cycles of docetaxel. Patients will be randomized in Arm A and will receive 6 additional cycles of docetaxel (75 mg/m2 every 3 weeks) after randomization.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel is administered at the dose of 75 mg/m² over 1 hour every 3 weeks for 6 cycles (D1=D22).

    Arm title
    		 Group II: Arm B
    Arm description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel resistant (≥ 5 CTCs/7.5 mL) after 2 cycles of docetaxel. Patients will be randomized in Arm B and will receive 6 cycles of cabazitaxel (20 mg/m2 every 3 weeks) after randomization.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    patients will be treated with intravenous cabazitaxel 20 mg/m2 every 3 weeks for 6 cycles (D1=D22).

    Number of subjects in period 1
    		Group I: Cohort Group II: Arm A Group II: Arm B
    Started
    21
    6
    4
    Completed
    4
    0
    0
    Not completed
    17
    6
    4
         Early termination requested by the sponsor
    1
    -
    -
         Promotor's decision
    1
    -
    -
         Early termination by the sponsor
    1
    -
    -
         Death
    13
    6
    3
         Promotor decision
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group I: Cohort
    Reporting group description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel sensitive (<5 CTCs/7.5 mL) after 2 cycles of docetaxel. The patients will receive 6 additional cycles of docetaxel..

    Reporting group title
    Group II: Arm A
    Reporting group description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel resistant (≥ 5 CTCs/7.5 mL) after 2 cycles of docetaxel. Patients will be randomized in Arm A and will receive 6 additional cycles of docetaxel (75 mg/m2 every 3 weeks) after randomization.

    Reporting group title
    Group II: Arm B
    Reporting group description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel resistant (≥ 5 CTCs/7.5 mL) after 2 cycles of docetaxel. Patients will be randomized in Arm B and will receive 6 cycles of cabazitaxel (20 mg/m2 every 3 weeks) after randomization.

    Reporting group values
    		 Group I: Cohort Group II: Arm A Group II: Arm B Total
    Number of subjects
    		 21 6 4 31
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 5 3 1 9
        From 65-84 years
    		 16 3 3 22
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 70 (52 to 82) 64.5 (58 to 75) 71 (55 to 72) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 21 6 4 31
    ECOG
    Units: Subjects
        ECOG 0
    		 9 2 0 11
        ECOG 1
    		 11 2 4 17
        ECOG 2
    		 1 2 0 3
    Clinical exam
    Units: Subjects
        Normal
    		 20 6 4 30
        Abnormal
    		 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Group I: Cohort
    Reporting group description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel sensitive (<5 CTCs/7.5 mL) after 2 cycles of docetaxel. The patients will receive 6 additional cycles of docetaxel..

    Reporting group title
    Group II: Arm A
    Reporting group description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel resistant (≥ 5 CTCs/7.5 mL) after 2 cycles of docetaxel. Patients will be randomized in Arm A and will receive 6 additional cycles of docetaxel (75 mg/m2 every 3 weeks) after randomization.

    Reporting group title
    Group II: Arm B
    Reporting group description
    		 Patients with unfavorable CTC count (≥ 5 CTCs/7.5 mL) before initiation of docetaxel chemotherapy and subsequently docetaxel resistant (≥ 5 CTCs/7.5 mL) after 2 cycles of docetaxel. Patients will be randomized in Arm B and will receive 6 cycles of cabazitaxel (20 mg/m2 every 3 weeks) after randomization.

    Primary: Biological activity of chemotherapy

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    End point title
    		 Biological activity of chemotherapy [1]
    End point description
    Biological activity of chemotherapy was defined as < 5 CTCs per 7.5 mL at the end of chemotherapy with docetaxel or cabazitaxel (irrespective of the number of cycles received after the 2 cycles of docetaxel preceeding randomization). The CellSearch CTC Test (Janssen) was used to assess CTC. Biological activity will be categorized as follows: - Biological Activity: if < 5 CTCs per 7.5 mL are observed at the end of the treatment, - Absence of biological activity: if ≥ 5 CTCs per 7.5 mL are observed at the end of the treatment. - No interpretable results: CTC count performed at the end of the treatment but results not interpretable
    End point type
    Primary
    End point timeframe
    18 weeks after randomisation
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint was the biological activity of chemotherapy defined as < 5 CTCs per 7.5 mL at the end of chemotherapy with Docetaxel or Cabazitaxel (irrespective of the number of cycles received after the 2 cycles of docetaxel preceding randomization). In group I, there were 10 failures (47.6%) and 10 success (52.4%). In group II, there were 6 (100.0%) failures in arm A, and 2 (50.0%) success and 2 (50.0%) failures in arm B (p=0.133). There were no statistical comparisons between groups.
    End point values
    		 Group I: Cohort Group II: Arm A Group II: Arm B
    Number of subjects analysed
    21
    6
    4
    Units: Number
        FAILURE
    10
    6
    2
        SUCCESS
    11
    0
    2
    No statistical analyses for this end point

    Secondary: Prostate Specific Antigen PSA progression-free-survival (PSA-PFS)

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    End point title
    		 Prostate Specific Antigen PSA progression-free-survival (PSA-PFS)
    End point description
    Prostate Specific Antigen -Progression Free Survival (PSA-PFS) is defined as the time from the date of randomization until first evidence of PSA progression or until death from any cause, whichever comes first. PSA progression is defined by the criteria of the Prostate Cancer Clinical Trials Working Group (PCWG 3) [1] as follows : -For patients with a PSA decrease observed after baseline: PSA progression is defined as the first PSA increase that is ≥ 25% and ≥ 2 ng/mL above the nadir, and which is confirmed by a second value ≥ 3 weeks later. The date of progression corresponds to the date of the first PSA increase that is ≥ 25% and ≥ 2 ng/mL above the nadir. -For patients without a PSA decrease observed after baseline: PSA progression is defined as PSA progression ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. -PSA value will be assessed at each cycle of chemotherapy.
    End point type
    Secondary
    End point timeframe
    The time from the date of randomization until first evidence of PSA progression or until death from any cause, whichever comes first.
    End point values
    		 Group I: Cohort Group II: Arm A Group II: Arm B
    Number of subjects analysed
    21
    6
    4
    Units: Months
        median (confidence interval 95%)
    7.9 (3.6 to 9.2)
    1.8 (0.7 to 6.4)
    1.4 (1.4 to 4.0)
    Statistical analysis title
    		 PSA-PFS Analysis
    Comparison groups
    Group II: Arm A v Group II: Arm B
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.489
    Method
    		 Logrank
    Confidence interval

    Secondary: Radiographic progression-free survival (rPFS)

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    End point title
    		 Radiographic progression-free survival (rPFS)
    End point description
    rPFS is defined as the time from the date of randomization to the date when the first site of disease is found to progress (using a manifestation-specific definition of progression), or death from any cause, whichever occurs first: - Soft tissue: Radiographic progression is defined as an increase in measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). - Bone: Bone progression is defined by the occurrence of at least 2 new lesions. - Imaging will be assessed at baseline, after 2 cycles, at the end of treatment and at any time whenever investigator considers it necessary..
    End point type
    Secondary
    End point timeframe
    The time from the date of randomization to the date when the first site of disease is found to progress, or death from any cause, whichever occurs first
    End point values
    		 Group I: Cohort Group II: Arm A Group II: Arm B
    Number of subjects analysed
    21
    6
    4
    Units: Months
        median (confidence interval 95%)
    7.7 (3.8 to 9.1)
    4.2 (1.5 to 8.5)
    4.8 (4.0 to 13.5)
    Statistical analysis title
    		 rPFS analysis
    Comparison groups
    Group II: Arm A v Group II: Arm B
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.425
    Method
    		 Logrank
    Confidence interval

    Secondary: Time to pain progression

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    End point title
    		 Time to pain progression
    End point description
    Time to pain progression is defined as the time from the date of randomization to the first documentation of pain progression , as used by Bash et al. - Progression of mean pain intensity (items 3 [worst pain], 4 [least], 5 [mean], and 6 [present]) was defined as a 30% increase from baseline* (increase necessary at two consecutive assessments at least 4 weeks apart without a decrease in WHO analgesic usage score). - Evaluation of mean pain progression was based on the Short Form Brief Pain inventory. - Analgesic use was scored according to WHO criteria: zero for no use, one for use of non-opiate analgesics (eg, nonsteroidal anti-inflammatory drugs, acetaminophen, antidepressants, and agents targeting neuropathic pain), two for use of weak opiates for moderate pain (eg,codeine and tramadol), and three for strong opiates for severe pain (eg, morphine and fentanyl). - Pain and analgesic use as per WHO was assessed every 2 cycles of chemotherapy, as well at treatment discontinuation
    End point type
    Secondary
    End point timeframe
    at 1 year after randomization
    End point values
    		 Group I: Cohort Group II: Arm A Group II: Arm B
    Number of subjects analysed
    21
    6
    4
    Units: percent
        number (confidence interval 95%)
    5.1 (0.3 to 21.3)
    16.7 (0.5 to 54.9)
    0 (0 to 0)
    Statistical analysis title
    		 Time to pain progression Analysis
    Comparison groups
    Group II: Arm A v Group II: Arm B
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291
    Method
    		 Gray test
    Confidence interval

    Secondary: Disease Specific Survival (DSS)

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    End point title
    		 Disease Specific Survival (DSS)
    End point description
    DSS was defined as the time from the date of randomization to the date of prostate cancer death.
    End point type
    Secondary
    End point timeframe
    at 1 year after randomization
    End point values
    		 Group I: Cohort Group II: Arm A Group II: Arm B
    Number of subjects analysed
    21
    6
    4
    Units: percent
        number (not applicable)
    41.8
    83.3
    50.0
    Statistical analysis title
    		 DSS Anlaysis
    Comparison groups
    Group II: Arm A v Group II: Arm B
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.282
    Method
    		 Gray test
    Confidence interval

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    OS was defined as the time from the date of randomization to the date of death from any cause. Note:
    End point type
    Secondary
    End point timeframe
    The time from the date of randomization to the date of death from any cause.
    End point values
    		 Group I: Cohort Group II: Arm A Group II: Arm B
    Number of subjects analysed
    21
    6
    4
    Units: Median (months)
        number (not applicable)
    12.5
    8.1
    4.4
    Statistical analysis title
    		 OS analysis
    Comparison groups
    Group II: Arm A v Group II: Arm B
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.784
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from signature of the informed consent form up to 30 days after the post-treatment CTC sample performed 4 weeks after the last cycle of the study treatment (docetaxel or cabazitaxel).
    Adverse event reporting additional description
    Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Group I
    Reporting group description
    		 -

    Reporting group title
    Group II: Arm A
    Reporting group description
    		 -

    Reporting group title
    Group II: Arm B
    Reporting group description
    		 -

    Serious adverse events
    		 Group I Group II: Arm A Group II: Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 21 (33.33%)
    3 / 6 (50.00%)
    3 / 4 (75.00%)
         number of deaths (all causes)
    13
    6
    3
         number of deaths resulting from adverse events
    0
    0
    1
    Cardiac disorders
    Pulmonary oedema
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aplasia bone marrow
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Febrile aplasia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Anasarca
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Macrophage activation syndrome
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Ulcerative duodenitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hepatic cytolysis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumopathy
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute renal insufficiency
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cholecystitis infective
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septicemia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group I Group II: Arm A Group II: Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 21 (100.00%)
    6 / 6 (100.00%)
    4 / 4 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    1
    Hypotension
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Painful hematoma
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Varicose ulceration
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Thromboembolic event
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Varicose vein
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Aches
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Anasarca
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Chills
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Costal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Oedema limbs
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    12
    0
    0
    Extravasation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Face edema
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    21 / 21 (100.00%)
    6 / 6 (100.00%)
    4 / 4 (100.00%)
         occurrences all number
    86
    33
    24
    Fever
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 6 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    1
    3
    0
    Gait disturbance
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    General physical health deterioration
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    0
    1
    Hip pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperthermia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema lower limb
         subjects affected / exposed
    7 / 21 (33.33%)
    0 / 6 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    14
    0
    4
    Infusion site extravasation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    3
    Mucositis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Mucositis oral
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    0
    2
    Edema
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    5
    0
    0
    Edema limb
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pain
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    4
    0
    Chest pain
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    4
    0
    Thoracic pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Throat pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Xerosis
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    3
    5
    0
    Reproductive system and breast disorders
    Oedema genital
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
         occurrences all number
    0
    7
    5
    Penile irritation
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphonia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    5 / 21 (23.81%)
    1 / 6 (16.67%)
    3 / 4 (75.00%)
         occurrences all number
    5
    2
    6
    Epistaxis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonitis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    0
    Rhinorrhea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Voice alteration
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Depression
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Depressive syndrom
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    5
    0
    1
    Hallucination
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Libido decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    0
    Alkaline phosphatase increased
         subjects affected / exposed
    4 / 21 (19.05%)
    3 / 6 (50.00%)
    4 / 4 (100.00%)
         occurrences all number
    8
    6
    10
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
         occurrences all number
    3
    1
    4
    Blood lactate dehydrogenase
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Creatinine increased
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    8
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
         occurrences all number
    4
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Hematuria
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    0
    Hypocalcemia
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    4
    0
    2
    Hyponatraemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    7
    0
    4
    Neutrophil count decreased
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
         occurrences all number
    4
    5
    2
    Platelet count decreased
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 6 (16.67%)
    3 / 4 (75.00%)
         occurrences all number
    1
    2
    11
    Weight gain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    0
    Weight loss
         subjects affected / exposed
    13 / 21 (61.90%)
    1 / 6 (16.67%)
    2 / 4 (50.00%)
         occurrences all number
    32
    1
    5
    White blood cell count decreased
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    0
    1
    Injury, poisoning and procedural complications
    Chemical phlebitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac arrhythmia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac decompensation
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Tricuspid insufficiency
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    7 / 21 (33.33%)
    0 / 6 (0.00%)
    4 / 4 (100.00%)
         occurrences all number
    9
    0
    14
    Dizziness
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Drowsiness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Dysaesthesia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoesthesia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Memory loss
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    8
    0
    Metal taste in mouth
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Paresthesia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    10 / 21 (47.62%)
    1 / 6 (16.67%)
    2 / 4 (50.00%)
         occurrences all number
    30
    5
    6
    Presyncope
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Radicular pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    8
    0
    1
    Head pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    2
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    12 / 21 (57.14%)
    4 / 6 (66.67%)
    4 / 4 (100.00%)
         occurrences all number
    66
    26
    30
    Febrile neutropenia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Lymphopenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Watering
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    6
    0
    0
    Eye disorders
    Acuity visual loss
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Convergent strabismus
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Eye tearing
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Lacrimation disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Myosis/Ptosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 6 (33.33%)
    2 / 4 (50.00%)
         occurrences all number
    2
    2
    4
    Bleeding ulcer
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    0
    Constipation
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    6
    0
    1
    Diarrhea
         subjects affected / exposed
    15 / 21 (71.43%)
    3 / 6 (50.00%)
    3 / 4 (75.00%)
         occurrences all number
    35
    3
    10
    Digestive disorder
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    Hemorrhoids
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hiatal hernia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    10 / 21 (47.62%)
    2 / 6 (33.33%)
    2 / 4 (50.00%)
         occurrences all number
    13
    5
    3
    Pyrosis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Proctitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Rectorrhage
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Gastric pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombosed hemorrhoids
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    6 / 21 (28.57%)
    2 / 6 (33.33%)
    4 / 4 (100.00%)
         occurrences all number
    8
    3
    4
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    8 / 21 (38.10%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
         occurrences all number
    31
    2
    5
    Cutaneous lesion
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Dry skin
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    11
    0
    0
    Erythema
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hand and foot syndrome
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Nail disorder
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    13
    1
    0
    Nail toxicity
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    3
    2
    0
    Night sweats
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Onychodystrophy
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    5
    0
    Onychopathia
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    8
    0
    0
    Onycholysis
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    7
    0
    0
    Peripheral rash
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Rash at injection site
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    7
    0
    0
    Redness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Skin pallor
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Acute renal failure
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Dilatation of left urinary cavities
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Dysuria
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Partial urinary retention
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Renal insufficiency
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Urethral obstruction
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    7
    0
    0
    Asthenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    16
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    5
    Bone pain
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    5
    0
    2
    Cervical pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Cramps in the calves
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Dorsal pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Femoral pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    Generalised muscle weakness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Knee pain
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    8
    0
    2
    Femur pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Sacroiliac pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Lumbar pain
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 6 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    2
    3
    2
    Muscle weakness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    16
    0
    0
    Osteonecrosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Sacral pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Sarcopenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Scapula pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Shoulder pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal disorder
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Glans mycosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Neoplasic meningitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Oral mycosis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    Paronychia
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    14
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    Tooth abscess
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    8 / 21 (38.10%)
    3 / 6 (50.00%)
    4 / 4 (100.00%)
         occurrences all number
    12
    10
    11
    Dehydration
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercalcemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 6 (16.67%)
    2 / 4 (50.00%)
         occurrences all number
    3
    1
    2
    Hypouricaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Aug 2018
    - Safety measures regarding the administration of docetaxel - Alignment of secondary endpoints and evaluation criteria for the duration of treatment - Update of secondary endpoints - Clarification of information on the processing of personal data - Update of the investigators list
    08 Mar 2019
    Update of the investigators list
    03 Oct 2019
    Update of the investigators list
    27 Nov 2019
    Update of the investigators list
    04 Feb 2020
    Update of the investigators list
    02 Sep 2020
    - Addition of a test to monitor heart function before starting treatment - Reformulation of the assessment methods for the secondary endpoints regarding to time to pain progression - Correction and precision regarding the frequency of tumour evaluation by imaging using RECIST v1.1 - Update on participant rights according to data protection regulation law - Withdrawal of the Oscar Lambret centre - Lilles
    07 Jun 2021
    - Prematurely discontinuation of the study due to poor recruitment of participants - Addendum on participant rights according to data protection regulation law

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    07 Jun 2021
    Prematurely discontinuation of the study due to poor recruitment of participants, since enrolment opened in December 2018, only 40 patients with CTC count ≥5 /7.5 mL were included.
    -

    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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    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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