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    Clinical Trial Results:
    Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

    Summary
    EudraCT number
    		 2011-003415-31
    Trial protocol
    		 HU   FR   GR   NO   IT   DE   PL   ES  
    Global end of trial date
    02 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    15 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARD12166
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01500720
    WHO universal trial number (UTN)
    		 U1111-1123-3503
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in subjects with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 5
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Greece: 14
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 13
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Russian Federation: 21
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    179
    EEA total number of subjects
    105
    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)
    116
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 232 subjects were screened of which 53 were screen failure and 179 were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cabazitaxel
    Arm description
    		 Cabazitaxel on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabazitaxel
    Investigational medicinal product code
    XRP6258
    Other name
    Jevtana
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cabazitaxel 25 mg/m^2.

    Arm title
    		 Topotecan
    Arm description
    		 Topotecan on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Topotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Topotecan 1.5 mg/m^2.

    Number of subjects in period 1
    		Cabazitaxel Topotecan
    Started
    90
    89
    Treated
    89
    88
    Completed
    85
    80
    Not completed
    5
    9
         Randomized But Not Treated
    1
    1
         Unspecified
    4
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    		 Cabazitaxel on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

    Reporting group title
    Topotecan
    Reporting group description
    		 Topotecan on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

    Reporting group values
    		 Cabazitaxel Topotecan Total
    Number of subjects
    		 90 89 179
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.9 ± 9.4 61.6 ± 10 -
    Gender categorical
    Units: Subjects
        Female
    		 27 27 54
        Male
    		 63 62 125
    Race
    Units: Subjects
        Caucasian/White
    		 80 82 162
        Black
    		 1 2 3
        Asian/Oriental
    		 9 4 13
        Other
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic
    		 4 3 7
        Not Hispanic
    		 86 86 172
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    ECOG criteria: 0: Fully active 1: Ambulatory, carry out work of a light or sedentary nature 2: Ambulatory, capable of all selfcare 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours 4: Completely disabled, no selfcare, totally confined to bed or chair 5: Dead
    Units: Subjects
        ECOG criteria: 0
    		 31 17 48
        ECOG criteria: 1
    		 59 71 130
        ECOG criteria: 2
    		 0 1 1
    Primary Tumor Site
    Units: Subjects
        Lungs
    		 16 20 36
        Right Lung
    		 33 43 76
        Left Lung
    		 40 26 66
        Other: Mediastino-Hilar
    		 1 0 1
    Stage at Diagnosis
    Disease stages were decided based on tumor size, lymph nodes and metastasis (as per National Comprehensive Cancer Network guidelines Version 2.2013).
    Units: Subjects
        IIA
    		 1 1 2
        IIB
    		 2 1 3
        IIIA
    		 2 12 14
        IIIB
    		 25 15 40
        IV
    		 57 55 112
        Unknown
    		 3 5 8
    Number of Organs Involved
    Units: organs
        arithmetic mean (standard deviation)
    		 3.6 ± 1.3 3.8 ± 1.4 -

    End points

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    End points reporting groups
    Reporting group title
    Cabazitaxel
    Reporting group description
    		 Cabazitaxel on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

    Reporting group title
    Topotecan
    Reporting group description
    		 Topotecan on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression. Intent-to-treat (ITT) population included all randomized subjects.
    End point type
    Primary
    End point timeframe
    Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
    End point values
    		 Cabazitaxel Topotecan
    Number of subjects analysed
    90
    89
    Units: months
        median (confidence interval 95%)
    1.4 (1.4 to 1.5)
    3 (2.7 to 4.1)
    Statistical analysis title
    		 Cabazitaxel vs. Topotecan
    Statistical analysis description
    Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.
    Comparison groups
    Cabazitaxel v Topotecan
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [1]
    Method
    		 Stratified Two-Sided Log-Rank Test
    Parameter type
    		 Cox proportional hazard
    Point estimate
    2.169
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.563
         upper limit
    		 3.01
    Notes
    [1] - P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the subject was known to be alive. Median time was estimated by Kaplan-Meier curve. ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization to date of death (maximum 15 months)
    End point values
    		 Cabazitaxel Topotecan
    Number of subjects analysed
    90
    89
    Units: months
        median (confidence interval 95%)
    5.2 (3.38 to 6.11)
    6.8 (5.03 to 8.08)
    No statistical analyses for this end point

    Secondary: Progression Free Rate at Week 12

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    End point title
    		 Progression Free Rate at Week 12
    End point description
    Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of subjects who were progression free at week 12 are reported. ITT population.
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    		 Cabazitaxel Topotecan
    Number of subjects analysed
    90
    89
    Units: percentage of subjects
        number (confidence interval 95%)
    18.9 (11.4 to 28.5)
    52.8 (41.9 to 63.5)
    No statistical analyses for this end point

    Secondary: Overall Objective Tumor Response Rate

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    End point title
    		 Overall Objective Tumor Response Rate
    End point description
    Overall objective tumor response was defined as the proportion of subjects with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of subjects with overall objective tumor response is reported. ITT population.
    End point type
    Secondary
    End point timeframe
    Randomization to disease progression/occurrence (maximum 7.6 months)
    End point values
    		 Cabazitaxel Topotecan
    Number of subjects analysed
    90
    89
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 4.9)
    10.1 (4.5 to 19)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form until 30 days after last study treatment administration (maximum 66 weeks) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and death that occurred during the ‘on treatment period’ (from the first study treatment administration until 30 days after the last dose of study treatment). Safety population all randomized subjects who received at least one dose of study medication (treated).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Topotecan
    Reporting group description
    		 Topotecan on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

    Reporting group title
    Cabazitaxel
    Reporting group description
    		 Cabazitaxel on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

    Serious adverse events
    		 Topotecan Cabazitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    41 / 88 (46.59%)
    36 / 89 (40.45%)
         number of deaths (all causes)
    13
    12
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour Pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Generalised Oedema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Performance Status Decreased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease Progression
         subjects affected / exposed
    4 / 88 (4.55%)
    6 / 89 (6.74%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 6
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemoptysis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Haemorrhage
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary Microemboli
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Respiratory Distress
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet Count Decreased
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral Injury
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Pericardial Effusion
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary Failure
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Nervous system disorders
    Paraparesis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile Neutropenia
         subjects affected / exposed
    10 / 88 (11.36%)
    6 / 89 (6.74%)
         occurrences causally related to treatment / all
    10 / 10
    6 / 6
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph Node Pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    6 / 88 (6.82%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    6 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    10 / 88 (11.36%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    14 / 14
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal Fistula
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Cutaneous Lupus Erythematosus
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Allergic
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary Retention
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 88 (6.82%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neutropenic Sepsis
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 89 (3.37%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Neutropenic Infection
         subjects affected / exposed
    5 / 88 (5.68%)
    4 / 89 (4.49%)
         occurrences causally related to treatment / all
    4 / 5
    3 / 4
         deaths causally related to treatment / all
    1 / 2
    2 / 2
    Lung Infection
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hyponatraemia
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 89 (3.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Topotecan Cabazitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 88 (84.09%)
    67 / 89 (75.28%)
    Investigations
    Neutrophil Count Decreased
         subjects affected / exposed
    6 / 88 (6.82%)
    3 / 89 (3.37%)
         occurrences all number
    7
    3
    Weight Decreased
         subjects affected / exposed
    4 / 88 (4.55%)
    7 / 89 (7.87%)
         occurrences all number
    4
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 88 (5.68%)
    2 / 89 (2.25%)
         occurrences all number
    6
    2
    Headache
         subjects affected / exposed
    9 / 88 (10.23%)
    6 / 89 (6.74%)
         occurrences all number
    16
    7
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    12 / 88 (13.64%)
    0 / 89 (0.00%)
         occurrences all number
    15
    0
    Neutropenia
         subjects affected / exposed
    19 / 88 (21.59%)
    2 / 89 (2.25%)
         occurrences all number
    25
    2
    Leukopenia
         subjects affected / exposed
    6 / 88 (6.82%)
    1 / 89 (1.12%)
         occurrences all number
    6
    1
    Febrile Neutropenia
         subjects affected / exposed
    5 / 88 (5.68%)
    4 / 89 (4.49%)
         occurrences all number
    5
    4
    Anaemia
         subjects affected / exposed
    18 / 88 (20.45%)
    4 / 89 (4.49%)
         occurrences all number
    21
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    22 / 88 (25.00%)
    26 / 89 (29.21%)
         occurrences all number
    24
    29
    Asthenia
         subjects affected / exposed
    16 / 88 (18.18%)
    10 / 89 (11.24%)
         occurrences all number
    20
    11
    Non-Cardiac Chest Pain
         subjects affected / exposed
    6 / 88 (6.82%)
    6 / 89 (6.74%)
         occurrences all number
    7
    6
    Pyrexia
         subjects affected / exposed
    7 / 88 (7.95%)
    4 / 89 (4.49%)
         occurrences all number
    10
    4
    Oedema Peripheral
         subjects affected / exposed
    5 / 88 (5.68%)
    1 / 89 (1.12%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 89 (5.62%)
         occurrences all number
    2
    5
    Abdominal Pain
         subjects affected / exposed
    3 / 88 (3.41%)
    8 / 89 (8.99%)
         occurrences all number
    3
    8
    Vomiting
         subjects affected / exposed
    7 / 88 (7.95%)
    15 / 89 (16.85%)
         occurrences all number
    7
    20
    Stomatitis
         subjects affected / exposed
    3 / 88 (3.41%)
    8 / 89 (8.99%)
         occurrences all number
    4
    8
    Nausea
         subjects affected / exposed
    11 / 88 (12.50%)
    14 / 89 (15.73%)
         occurrences all number
    14
    18
    Diarrhoea
         subjects affected / exposed
    9 / 88 (10.23%)
    17 / 89 (19.10%)
         occurrences all number
    11
    26
    Constipation
         subjects affected / exposed
    9 / 88 (10.23%)
    8 / 89 (8.99%)
         occurrences all number
    9
    8
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    21 / 88 (23.86%)
    8 / 89 (8.99%)
         occurrences all number
    21
    8
    Cough
         subjects affected / exposed
    8 / 88 (9.09%)
    10 / 89 (11.24%)
         occurrences all number
    8
    11
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 88 (5.68%)
    5 / 89 (5.62%)
         occurrences all number
    5
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 88 (6.82%)
    2 / 89 (2.25%)
         occurrences all number
    6
    2
    Back Pain
         subjects affected / exposed
    5 / 88 (5.68%)
    8 / 89 (8.99%)
         occurrences all number
    9
    8
    Musculoskeletal Pain
         subjects affected / exposed
    5 / 88 (5.68%)
    9 / 89 (10.11%)
         occurrences all number
    6
    9
    Myalgia
         subjects affected / exposed
    0 / 88 (0.00%)
    5 / 89 (5.62%)
         occurrences all number
    0
    5
    Pain In Extremity
         subjects affected / exposed
    6 / 88 (6.82%)
    1 / 89 (1.12%)
         occurrences all number
    6
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    13 / 88 (14.77%)
    16 / 89 (17.98%)
         occurrences all number
    15
    20

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2012
    - Changes made following major comments received from study investigators and from Health Authorities or Ethics Committees/International Review Boards further to regulatory submissions of study protocol. - Editorial changes to improve clarity. - Updated the written subject information in order to reflect the changes within the protocol.

    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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    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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