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    Clinical Trial Results:
    Randomised phase II study evaluating, as first-line chemotherapy, weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in oestrogen receptor positive, HER2 negative patients with advanced breast cancer.

    Summary
    EudraCT number
    2012-003530-16
    Trial protocol
    AT   ES   PL   FR  
    Global end of trial date
    05 Sep 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Nov 2019
    First version publication date
    07 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PM0259CA231B0
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Médicament
    Sponsor organisation address
    45 place Abel Gance, Boulgone-Billancourt, France, 92654
    Public contact
    Gustavo Villanova, Pierre Fabre Medicament, +33 149 10 82 65, gustavo.villanova@pierre-fabre.com
    Scientific contact
    Gustavo Villanova, Pierre Fabre Medicament, +33 149 10 82 65, gustavo.villanova@pierre-fabre.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
    18 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate, as a first-line chemotherapy, the disease control rate (DCR) of weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in oestrogen receptor positive, HER2 negative patients with advanced breast cancer.
    Protection of trial subjects
    This study was performed in accordance with the principles stated in the Declaration of Helsinki and subsequent amendments and in accordance with the Good Clinical Practice Guideline (CPMP/ICH/135/95).
    Background therapy
    Prophylactic oral anti-emetic medication with an 5-HT3 antagonist was recommended before each Oral Vinorelbine (OV) administration. In addition, the patient were to be provided with adequate oral antiemetics at home. Anti-emetic prophylaxis for patients receiving weekly paclitaxel was allowed and was given according to investigator’s discretion. The use of corticosteroids as anti-emetic treatment was allowed. All patients were given premedication with corticosteroids, antihistamines, and H2 antagonists prior to paclitaxel therapy. Granulocyte stimulating growth factors may be given to patients who experienced febrile neutropenia, grade 4 asymptomatic neutropenia or neutropenic infection according to institutional rules.
    Evidence for comparator
    The rationale for comparing Oral Vinorelbine (OV) and weekly Paclitaxel (PAC) as first-line chemotherapy for advanced ER-positive breast cancer patients is based on the fact that chemotherapy is widely used in the management of ER-positive breast cancer patients pre-treated by hormone therapy. The use of single-agent chemotherapy in this setting has been validated in guidelines of management of the disease. Both Paclitaxel and Vinorelbine are recommended among the standard available chemotherapy agents for Metastatic Breast Cancer (MBC).
    Actual start date of recruitment
    01 Dec 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Regulatory reason
    Long term follow-up duration
    25 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 33
    Country: Number of subjects enrolled
    Spain: 34
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Argentina: 8
    Country: Number of subjects enrolled
    Brazil: 32
    Worldwide total number of subjects
    131
    EEA total number of subjects
    91
    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)
    82
    From 65 to 84 years
    48
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    Twenty-six active centres in 6 countries enrolled 131 oestrogen receptor positive, HER2 negative women with advanced breast cancer during a study inclusion period of 34 months.

    Pre-assignment
    Screening details
    A 28-day screening period was planned before randomisation and screened for ER+/HER2- status women with advanced breast cancer. All screened patients were randomised 1:1 in the 2 arms.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open-label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OV arm
    Arm description
    66 patients were randomised in the OV arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Oral Vinorelbine (OV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    OV 60 mg/m²/week (day 1, 8, 15) for the first cycle, then increased to 80 mg/m²/week from the second cycle in the absence of severe haematological toxicity (one episode of grade 4 neutropenia or 2 consecutive episodes of grade 3 neutropenia during the initial treatment period). In case of severe haematological toxicity, the subsequent administrations were maintained at 60 mg/m²/week. Once increased to 80 mg/m²/week, in case of severe haematological toxicity the dose was reduced to 60 mg/m²/week with a possible re-escalation to 80 mg/m²/week if no haematological toxicity occurred during the last 3 administrations.

    Arm title
    PAC arm
    Arm description
    65 patients were randomised in the PAC arm
    Arm type
    Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    weekly PAC, 80 mg/m²/week (day 1, 8 ,15), 1 hour infusion

    Number of subjects in period 1
    OV arm PAC arm
    Started
    66
    65
    Completed
    2
    0
    Not completed
    64
    65
         Progressive disease
    52
    35
         Death
    -
    2
         Other
    8
    14
         Non-related adverse events
    1
    3
         Related adverse events
    3
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OV arm
    Reporting group description
    66 patients were randomised in the OV arm.

    Reporting group title
    PAC arm
    Reporting group description
    65 patients were randomised in the PAC arm

    Reporting group values
    OV arm PAC arm Total
    Number of subjects
    66 65 131
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    42 40 82
        From 65-84 years
    24 24 48
        85 years and over
    0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.2 ± 10.6 62.0 ± 11.0 -
    Gender categorical
    Units: Subjects
        Female
    66 65 131
        Male
    0 0 0
    Performance status reported in baseline clinical examination
    Units: Subjects
        70
    1 9 10
        80
    9 16 25
        90
    16 12 28
        100
    40 28 68
    Histopathological type
    Units: Subjects
        Ductal, nos
    39 35 74
        Invasive with predominant intraductal component
    12 11 23
        Lobular
    6 5 11
        Invasive, nos
    4 4 8
        Invasive
    1 3 4
        Intraductal
    1 1 2
        Other
    1 1 2
        Other ductal form
    0 2 2
        30/40
    1 0 1
        Cancer, nos
    0 1 1
        Inflammatory
    1 0 1
        Class K
    0 1 1
        Mucinous
    0 1 1
    TNM classification
    TNM classification at the time of first diagnosis
    Units: Subjects
        Missing
    2 1 3
        Zero
    0 1 1
        One
    10 10 20
        1C
    6 6 12
        Two
    26 32 58
        Three
    12 4 16
        Four
    4 9 13
        4B
    2 2 4
        4D
    1 0 1
        X Classification
    3 0 3
    Stage at diagnosis
    Units: Subjects
        IA
    7 12 19
        IB
    0 0 0
        IIA
    14 10 24
        IIB
    13 12 25
        IIIA
    12 11 23
        IIIB
    4 10 14
        IIIC
    4 5 9
        IV
    8 4 12
        UK
    4 1 5
    Histopathological grade
    Units: Subjects
        SBR I
    2 1 3
        SBR II
    22 27 49
        SBR III
    22 15 37
        Unknown
    20 22 42
    Primary tumour site
    Units: Subjects
        Bilateral
    4 3 7
        Left breast
    36 29 65
        Right breast
    26 33 59
    Oestrogen receptors status
    Units: Subjects
        Negative
    1 0 1
        Positive
    65 65 130
    Progesterone Receptors status
    Units: Subjects
        Negative
    14 7 21
        Positive
    52 58 110
    Body weight
    Units: kg
        arithmetic mean (standard deviation)
    70.59 ± 15.45 66.75 ± 12.95 -
    Body surface area
    Units: m^2
        arithmetic mean (standard deviation)
    1.71 ± 0.164 1.67 ± 0.163 -
    Time between diagnosis and study entry
    Units: months
        arithmetic mean (standard deviation)
    79.16 ± 58.84 79.34 ± 64.61 -

    End points

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    End points reporting groups
    Reporting group title
    OV arm
    Reporting group description
    66 patients were randomised in the OV arm.

    Reporting group title
    PAC arm
    Reporting group description
    65 patients were randomised in the PAC arm

    Primary: Disease control rate (DCR)

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    End point title
    Disease control rate (DCR)
    End point description
    Disease control rate (DCR) is defined as the number of patients with confirmed complete response (CR) + number of patients with confirmed partial response (PR) + number of patients with stable disease (SD) rates with a minimal duration of 6 weeks. Mean (SD) treatment duration was 27.31 (30.97) weeks for patients in the OV arm and 24.06 (20.97) weeks for patients in the PAC arm. Disease control was observed in 50 patients (75.8%; [95%CI: 63.6%; 85.5%]) in the OV arm (n=66) and 49 patients (75.4%; [95%CI: 63.1%; 85.2%]) in the PAC arm (n=65).
    End point type
    Primary
    End point timeframe
    DCR according to investigator was calculated among the BOCR responders (CR and PR) and stable patients in the ITT population from the date of randomisation until the documentation of progression or death due to any cause.
    End point values
    OV arm PAC arm
    Number of subjects analysed
    66
    65
    Units: pourcentage
        number (confidence interval 95%)
    75.8 (63.6 to 85.5)
    75.4 (63.1 to 85.2)
    Statistical analysis title
    Primary efficacy analysis
    Statistical analysis description
    DCR was performed according to the Kaplan- Meier method. 95% CIs on the median were calculated using the Brookmeyer and Crowley method.
    Comparison groups
    OV arm v PAC arm
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    ≤ 0.05
    Method
    t-test, 2-sided
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    63.6
         upper limit
    85.5

    Secondary: Objective Response Rate (ORR)

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    End point title
    Objective Response Rate (ORR)
    End point description
    Objective response rate (ORR) was defined as the sum of CR and PR rate and evaluated in the ITT population (n=131).
    End point type
    Secondary
    End point timeframe
    ORR was evaluated from the date of randomisation until the end of study treatment period in the ITT population (n=131).
    End point values
    OV arm PAC arm
    Number of subjects analysed
    66
    65
    Units: pourcentage
        number (confidence interval 95%)
    19.7 (10.9 to 31.3)
    40.0 (28.0 to 52.9)
    No statistical analyses for this end point

    Secondary: Duration of disease control

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    End point title
    Duration of disease control
    End point description
    The duration of disease control (CR, PR and stabilisation of at least 6 weeks) was analysed in the subset of patients with disease control in the ITT population and estimated using Kaplan Meier anaylses. Patients who were lost to follow-up without progression, or reached the time point of analysis without a known record of progression or death had the duration of disease control censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occurred last. Patients who received a new anti-tumoural treatment, whatever the type of treatment, before their disease progression were censored at the start date of that new anti-tumoural treatment.
    End point type
    Secondary
    End point timeframe
    Duration of disease control according to investigator was calculated among the BOCR stable patients from the date of randomisation until the documentation of progression or death due to any cause.
    End point values
    OV arm PAC arm
    Number of subjects analysed
    66
    65
    Units: months
        median (confidence interval 95%)
    5.8 (5.0 to 8.7)
    8.7 (7.0 to 10.0)
    No statistical analyses for this end point

    Secondary: Duration of stable disease

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    End point title
    Duration of stable disease
    End point description
    Duration of SD (with best response SD ≥6 weeks or regardless the duration of best response SD) was analysed in a subset of patients with SD in the ITT population and estimated using the Kaplan Meier method. Patients who were lost to follow-up without progression, or reached the time point of analysis without a known record of progression or death had the duration of disease control censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occurred last. Patients who received a new anti-tumoural treatment, whatever the type of treatment, before their disease progression were censored at the start date of that new anti-tumoural treatment.
    End point type
    Secondary
    End point timeframe
    Duration of stable disease (SD), according to investigator, was calculated among the stable patients from the date of randomisation until the documentation of progression or death due to any cause.
    End point values
    OV arm PAC arm
    Number of subjects analysed
    66
    65
    Units: months
        median (confidence interval 95%)
    5.6 (4.4 to 6.8)
    7.0 (3.3 to 8.7)
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS)

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    End point title
    Progression-free survival (PFS)
    End point description
    PFS was estimated using the Kapaln Meier approach. Patients who were lost to follow-up, or reached the time point of analysis without a known record of progression or death had the progression-free survival censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occurred last. The mean duration of follow-up (SD) was 25.34 (14.69) months for the patients in the OV arm and 22.89 (14.81) months for patients in the PAC arm.
    End point type
    Secondary
    End point timeframe
    Progression-free survival (PFS) was calculated from the randomisation date until the date of first progression or date of death due to any cause if no progression was recorded before in the ITT population.
    End point values
    OV arm PAC arm
    Number of subjects analysed
    66
    65
    Units: months
        median (confidence interval 95%)
    5.5 (4.3 to 6.8)
    6.4 (5.1 to 8.3)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    Overall Survival (OS)
    End point description
    Overall Survival, defined as the duration between the date of randomisation and the date of death whatever the cause, was analysed in the ITT population. Overall survival of patients lost to follow-up before any record of death were censored at the date of last follow-up. Overall survival of patients alive at the time of analysis were censored at the date of last news (i.e. date of last administration, tumour assessment, clinical examination, haematological or biochemical assessment or date of last contact). At the cut-off date (18-Dec-2017) or last contact, death was reported for 96 patients (73.3%), 48 patients each in the two arms. Seventeen patients (25.8%) were still alive in the OV arm while 15 patients (23.1%) were still alive in the PAC arm. One patient (1.5%) in OV and two patients (3.1%) in PAC arm were lost to follow-up and two patients were still under treatment (both in OV arm).
    End point type
    Secondary
    End point timeframe
    Overall survival (OS) was analysed for the whole study period including follow-up. The median duration of follow-up (SD) was 25.34 (14.69) months for the patients in the OV arm and 22.89 (14.81) months for patients in the PAC arm.
    End point values
    OV arm PAC arm
    Number of subjects analysed
    66
    65
    Units: months
        median (confidence interval 95%)
    27.6 (20.2 to 34.5)
    22.3 (13.5 to 27.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported during the study treatment period. The mean duration of treatment (SD) was 27.31 weeks (30.97) for patients in the OV arm and 24.06 weeks (20.97) for patients in the PAC arm.
    Adverse event reporting additional description
    At the cut-off date (18/12/17) or last contact, death was reported for 96 patients, 48 in each arm. 17 patients were still alive in the OV arm and 15 in the PAC arm. 1 patient in OV and 2 patients in PAC arm were lost to follow-up and two patients were under treatment (OV arm). The median RDI per cycle for OV was 72.7% and 94.0% for PAC.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Evaluable population for safety
    Reporting group description
    131 treated patients were evaluable for safety (patients who received at least one study treatment dose).

    Serious adverse events
    Evaluable population for safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 131 (27.48%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    8 / 131 (6.11%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    asthenia
         subjects affected / exposed
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Granulocytopenia
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 131 (1.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4.6%
    Non-serious adverse events
    Evaluable population for safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    130 / 131 (99.24%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 131 (8.40%)
         occurrences all number
    28
    Investigations
    Weight decreased
         subjects affected / exposed
    41 / 131 (31.30%)
         occurrences all number
    202
    Weight increased
         subjects affected / exposed
    15 / 131 (11.45%)
         occurrences all number
    84
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    23 / 131 (17.56%)
         occurrences all number
    60
    Cough
         subjects affected / exposed
    19 / 131 (14.50%)
         occurrences all number
    39
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    28 / 131 (21.37%)
         occurrences all number
    146
    Paresthesia
         subjects affected / exposed
    16 / 131 (12.21%)
         occurrences all number
    31
    Headache
         subjects affected / exposed
    13 / 131 (9.92%)
         occurrences all number
    28
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    62 / 131 (47.33%)
         occurrences all number
    219
    Peripheral oedema
         subjects affected / exposed
    20 / 131 (15.27%)
         occurrences all number
    59
    Pyrexia
         subjects affected / exposed
    19 / 131 (14.50%)
         occurrences all number
    25
    Asthenia
         subjects affected / exposed
    17 / 131 (12.98%)
         occurrences all number
    64
    Chest pain
         subjects affected / exposed
    10 / 131 (7.63%)
         occurrences all number
    31
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    63 / 131 (48.09%)
         occurrences all number
    159
    Diarrhoea
         subjects affected / exposed
    53 / 131 (40.46%)
         occurrences all number
    140
    Vomiting
         subjects affected / exposed
    48 / 131 (36.64%)
         occurrences all number
    103
    Constipation
         subjects affected / exposed
    25 / 131 (19.08%)
         occurrences all number
    36
    Abdominal pain
         subjects affected / exposed
    16 / 131 (12.21%)
         occurrences all number
    36
    Abdominal pain upper
         subjects affected / exposed
    12 / 131 (9.16%)
         occurrences all number
    22
    Stomatitis
         subjects affected / exposed
    11 / 131 (8.40%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    32 / 131 (24.43%)
         occurrences all number
    207
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    23 / 131 (17.56%)
         occurrences all number
    59
    Back pain
         subjects affected / exposed
    18 / 131 (13.74%)
         occurrences all number
    36
    Pain in the extremity
         subjects affected / exposed
    16 / 131 (12.21%)
         occurrences all number
    41
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    21 / 131 (16.03%)
         occurrences all number
    40

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2012
    Contraception duration after paclitaxel treatment
    16 Jul 2013
    Local Argentina Pregnancy test frequency to local legislation
    04 Oct 2013
    Local Brazil Only menopausal women or who underwent surgical sterilisation
    28 Mar 2014
    Extension inclusion period until December 2014 + Helsinki update + typo corrections + Navelbine investigator’s brochure updates+ statistician
    20 Oct 2014
    Extension inclusion period until June 2015
    29 Oct 2014
    Local Brazil Pool of amendments PA05 and PA06 for unique submission to EC
    18 Dec 2017
    Change the definition of end of study

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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