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    Clinical Trial Results:
    Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer.

    Summary
    EudraCT number
    2004-000748-26
    Trial protocol
    ES  
    Global end of trial date
    21 May 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Jun 2022
    First version publication date
    19 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PM0259CA215B0
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Medicament
    Sponsor organisation address
    Les Cauquillous, Lavaur, France, 81500
    Public contact
    Gustavo Villanova, Pierre Fabre Medicament, +33 149108265, gustavo.villanova@pierre-fabre.com
    Scientific contact
    Gustavo Villanova, Pierre Fabre Medicament, +33 149108265, 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
    17 Dec 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) and i.v. trastuzumab (Herceptin) for HER2 positive patients.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the current Declaration of Helsinki and was consistent with International Conference on Harmonization Good Clinical Practice (ICH GCP) and applicable regulatory requirements. The study was conducted in compliance with the protocol. The protocol, amendments, the subject information leaflet and the subject informed consent were approved by the appropriate independent Ethics Committee(s) in the involved countries prior to implementation.
    Background therapy
    Patients had to receive full supportive care including antibiotics, anti-diarrhoeals, analgesics, transfusion of blood products, when appropriate. The use of drugs with laxative properties had to be avoided. Use of vitamin B6 pyridoxine (50-150 mg/BID) was permitted for symptomatic or secondary prophylactic treatment of hand-foot syndrome. Primary prophylactic use of Granulocyte Colony Stimulating Factors (G-CSF) was not allowed during the study treatment. G-CSF use was allowed as secondary prophylaxis in case of occurrence of febrile neutropenia, grade 4 asymptomatic neutropenia or neutropenic infection according to institutional rules. The use of G-CSF to treat neutropenia had to be correctly documented in patient’s medical file and in the CRF. Patients receiving opiates could receive treatment for constipation but had to be followed carefully. Patients receiving bisphosphonates were eligible for this study but had to have bone scans (and X-rays of areas of enhanced uptake indicative of bone metastasis) at baseline. Those starting bisphosphonates during the study but without other clear evidence of disease progression were not to be diagnosed as having progressive disease on that evidence alone.
    Evidence for comparator
    The study is a non-comparative, single-arm study. No control arm was planned as the study aimed at evaluating the triple combination regimen for the first time in this population of patients.
    Actual start date of recruitment
    08 Mar 2004
    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
    Australia: 20
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    Spain: 3
    Worldwide total number of subjects
    50
    EEA total number of subjects
    28
    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)
    41
    From 65 to 84 years
    8
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 13 centres in 7 countries enrolled a total of 50 women with previously untreated HER2 positive metastatic breast cancer between March 2004 and December 2010.

    Pre-assignment
    Screening details
    A 21-day screening period was planned before randomisation and screened previously untreated women with HER2 positive metastatic breast cancer. Once the screening period was successufully completed, patients who fulfilled the eligibility critera and gave their written consent, were included in the treatment period of the study.

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

    Arms
    Arm title
    Vinorelbine + Capecitabine + Trastuzumab
    Arm description
    This experimental arm consisted of all registered and treated patients (ITT population, N=50).
    Arm type
    Experimental

    Investigational medicinal product name
    Oral Vinorelbine (OV)
    Investigational medicinal product code
    Other name
    Navelbine
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received OV at the dose of 60 mg/m² on day 1 and day 8 every 3 weeks for cycle 1, and then 80 mg/m² on day 1 and day 8, every 3 weeks for subsequent cycles. The dosage was calculated according to BSA. Patients received at least 2 cycles of OV and treatment was administered until progressive disease, unacceptable toxicty or patient refusal.

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patient < 65 years old at the time of inclusion received capecitabine at the dose of 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14, every 3 weeks. Patient ≥ 65 years old at the time of inclusion received capecitabine at the dose of 750 mg/m² twice a day (1500 mg/m²) from day 1 to day 14, every 3 weeks. The dosage was calculated according to BSA. Patients received at least 2 cycles of capecitabine. Treatment was administered until disease progression, unacceptable toxicity, patient’s refusal or investigator’s decision.

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Herceptin
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received trastuzumab at the dose of 4 mg/kg on day 1 (loading dose) infused over a 90 minute period and then 2 mg/kg infused over a 30 minute period weekly starting on day 8 and continuing weekly for subsequent cycles. Patients received at least 2 cycles of trastuzumab. The amount of trastuzumab administered was calculated according to the patient’s body weight. Treatment was administered until disease progression, unacceptable toxicity, patient’s refusal or investigator’s decision. Patients were observed for at least six hours after the start of the first dose of trastuzumab (i.e. 4.5 hours from the end of the infusion). If no adverse events occured during the first infusion, the observation period for the second infusion was decreased to 2 hours after the start of the infusion (i.e. an hour and a half from the end of the infusion).

    Number of subjects in period 1
    Vinorelbine + Capecitabine + Trastuzumab
    Started
    50
    Completed
    3
    Not completed
    47
         Progressive disease
    18
         Protocol deviation
    1
         Physician decision
    8
         Adverse event, serious fatal
    1
         Adverse event, non-fatal
    12
         Consent withdrawn by subject
    6
         Patient's convenience
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period (overall trial)
    Reporting group description
    -

    Reporting group values
    Treatment period (overall trial) Total
    Number of subjects
    50 50
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    41 41
        From 65-84 years
    8 8
        85 years and over
    1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.6 ± 12.1 -
    Gender categorical
    Units: Subjects
        Female
    50 50
        Male
    0 0
    Karnofsky Performance Status (KPS)
    Units: Subjects
        70
    3 3
        80
    8 8
        90
    14 14
        100
    25 25
    Primary tumour site
    Units: Subjects
        Bilateral
    1 1
        Left breast
    20 20
        Right breast
    29 29
    Histological type
    Units: Subjects
        Ductal non other specified
    26 26
        Invasive with predominant intraductal component
    13 13
        Others
    11 11
    Oestrogen receptor (ER) status at initial diagnosis
    Units: Subjects
        ER positive
    20 20
        ER negative
    24 24
        Status unknown
    6 6
    Time from initial diagnosis to study entry
    Units: years
        arithmetic mean (standard deviation)
    3.5 ± 3.8 -
    Time from initial diagnosis to first relapse/progression
    Units: year
        arithmetic mean (standard deviation)
    2.7 ± 2.5 -
    Number of organs involved at study entry
    Units: number
        arithmetic mean (standard deviation)
    2.4 ± 1.3 -

    End points

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    End points reporting groups
    Reporting group title
    Vinorelbine + Capecitabine + Trastuzumab
    Reporting group description
    This experimental arm consisted of all registered and treated patients (ITT population, N=50).

    Primary: Overall response rate (ORR)

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    End point title
    Overall response rate (ORR) [1]
    End point description
    Overall response rate (ORR) was defined as the percentage of responses (complete and partial) in the ITT population according to investigator assessment based on the Response Evaluation Criteria in Solid Tumours (RECIST).
    End point type
    Primary
    End point timeframe
    ORR was calculated from the date of randomisation until the documentation of progression or death. Tumour evaluations were performed every 6 weeks until disease progression.
    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: If overall response (complete or partial) was observed in 20 or more patients, the study was considered to have met its primary endpoint.
    End point values
    Vinorelbine + Capecitabine + Trastuzumab
    Number of subjects analysed
    50
    Units: percentage of patients
        number (confidence interval 95%)
    69.4 (54.6 to 81.7)
    No statistical analyses for this end point

    Secondary: Time to first response

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    End point title
    Time to first response
    End point description
    The time to first response was defined as the time from the registration date to the date of first documented response (complete or partial) and was measured from the registration until the documentation of progression or death from any cause, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    Time to first response was measured during the study period.
    End point values
    Vinorelbine + Capecitabine + Trastuzumab
    Number of subjects analysed
    50
    Units: month
        median (confidence interval 95%)
    3.2 (3.0 to 4.0)
    No statistical analyses for this end point

    Secondary: Duration of response (DOR)

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    End point title
    Duration of response (DOR)
    End point description
    Duration of response was defined as the time from the date of first documented response (complete or partial) until the date of progression, death due to any cause or the date of start of a new anti-tumoural treatment.
    End point type
    Secondary
    End point timeframe
    DOR was measured among the responders during the study period.
    End point values
    Vinorelbine + Capecitabine + Trastuzumab
    Number of subjects analysed
    34
    Units: month
        median (confidence interval 95%)
    6.8 (3.0 to 10.3)
    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
    Progression-free survival (PFS) was defined as the time from the registration date until the date of progression or death due to any cause.
    End point type
    Secondary
    End point timeframe
    PFS was measured during the study period.
    End point values
    Vinorelbine + Capecitabine + Trastuzumab
    Number of subjects analysed
    50
    Units: month
        median (confidence interval 95%)
    12.8 (10.5 to 16.9)
    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 (OS) was defined as the duration between the date of registration and the date of death due to any cause.
    End point type
    Secondary
    End point timeframe
    OS was measured during the study period.
    End point values
    Vinorelbine + Capecitabine + Trastuzumab
    Number of subjects analysed
    50
    Units: month
        median (confidence interval 95%)
    47.0 (30.5 to 64.3)
    No statistical analyses for this end point

    Secondary: Time to treatment failure (TTF)

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    End point title
    Time to treatment failure (TTF)
    End point description
    Time to treatment failure (TTF) was defined as the time from the registration date up to the date of failure. Failure was defined as disease progression, death adverse event leading to withdrawal, patient's refusal, protocol deviation, lost to follow-up or start of a new anti-tumoural treatment.
    End point type
    Secondary
    End point timeframe
    TTF was measured during the study period.
    End point values
    Vinorelbine + Capecitabine + Trastuzumab
    Number of subjects analysed
    50
    Units: month
        median (confidence interval 95%)
    7.8 (5.6 to 9.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event (AE) that first occurred during the treatment period (i.e. from first study treatment administration date up to last administration date + 30 days) was recorded in the CRF and included in the analysis of AEs (on-study AE).
    Adverse event reporting additional description
    At the cut-off date (17-DEC-2010), 3 patients were still on treatment. A total of 17 patients were being followed for survival, 3 were lost to follow-up and 30 died.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    ITT population
    Reporting group description
    The population evaluable for safety consisted of all treated patients unless patient was lost to follow-up immediately after the start of the treatment (no follow-up visit).

    Serious adverse events
    ITT population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 50 (28.00%)
         number of deaths (all causes)
    30
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Left ventricular failure
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocarditis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 50 (2.00%)
         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
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Neutropenic infection
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    ITT population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 50 (100.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    5 / 50 (10.00%)
         occurrences all number
    17
    Hot flush
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    18
    Hypertension
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    4
    Hypotension
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    8
    Lymphoedema
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    12
    Phlebitis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    7 / 50 (14.00%)
         occurrences all number
    30
    Chills
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    10
    Fatigue
         subjects affected / exposed
    46 / 50 (92.00%)
         occurrences all number
    550
    Influenza like illness
         subjects affected / exposed
    17 / 50 (34.00%)
         occurrences all number
    41
    Injection site reaction
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Oedema
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    4
    Oedema peripheral
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    9
    Pain
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    11
    Pyrexia
         subjects affected / exposed
    37 / 50 (74.00%)
         occurrences all number
    436
    Unevaluable event
         subjects affected / exposed
    34 / 50 (68.00%)
         occurrences all number
    868
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    10 / 50 (20.00%)
         occurrences all number
    15
    Depression
         subjects affected / exposed
    11 / 50 (22.00%)
         occurrences all number
    24
    Insomnia
         subjects affected / exposed
    13 / 50 (26.00%)
         occurrences all number
    37
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    4
    Investigations
    Ejection fraction decreased
         subjects affected / exposed
    17 / 50 (34.00%)
         occurrences all number
    126
    Weight decreased
         subjects affected / exposed
    27 / 50 (54.00%)
         occurrences all number
    183
    Weight increased
         subjects affected / exposed
    15 / 50 (30.00%)
         occurrences all number
    197
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    12
    Ventricular dysfunction
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 50 (24.00%)
         occurrences all number
    23
    Dyspnoea
         subjects affected / exposed
    37 / 50 (74.00%)
         occurrences all number
    443
    Epistaxis
         subjects affected / exposed
    10 / 50 (20.00%)
         occurrences all number
    16
    hoarseness
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Pharyngolaryngeal abscess
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    11
    Postnasal drip
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    13
    Rhinitis allergic
         subjects affected / exposed
    7 / 50 (14.00%)
         occurrences all number
    52
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    8 / 50 (16.00%)
         occurrences all number
    39
    Dysgeusia
         subjects affected / exposed
    9 / 50 (18.00%)
         occurrences all number
    56
    Headache
         subjects affected / exposed
    19 / 50 (38.00%)
         occurrences all number
    107
    Neuropathic pain
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    12
    Peripheral motor neuropathy
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Peripheral sensory neuropathy
         subjects affected / exposed
    21 / 50 (42.00%)
         occurrences all number
    164
    Syncope
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    4
    Dry eye
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    66
    Lacrimation increased
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    97
    Vision blurred
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    6
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    5
    Vertigo
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    12
    Abdominal pain
         subjects affected / exposed
    22 / 50 (44.00%)
         occurrences all number
    44
    Abdominal pain upper
         subjects affected / exposed
    8 / 50 (16.00%)
         occurrences all number
    16
    Constipation
         subjects affected / exposed
    23 / 50 (46.00%)
         occurrences all number
    78
    Diarrhoea
         subjects affected / exposed
    45 / 50 (90.00%)
         occurrences all number
    597
    Dry mouth
         subjects affected / exposed
    5 / 50 (10.00%)
         occurrences all number
    10
    Dyspepsia
         subjects affected / exposed
    11 / 50 (22.00%)
         occurrences all number
    32
    Dysphagia
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    11
    Flatulence
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    8
    Gastritis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Haemorrhoids
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    9
    Ileus
         subjects affected / exposed
    34 / 50 (68.00%)
         occurrences all number
    431
    Nausea
         subjects affected / exposed
    46 / 50 (92.00%)
         occurrences all number
    571
    Rectal haemorrhage
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    7
    Stomatitis
         subjects affected / exposed
    40 / 50 (80.00%)
         occurrences all number
    496
    Toothache
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    44 / 50 (88.00%)
         occurrences all number
    465
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Hepatobiliary disorders
    Hepatic pain
         subjects affected / exposed
    5 / 50 (10.00%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    38 / 50 (76.00%)
         occurrences all number
    468
    Dry skin
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    19
    Erythema
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Hyperhidrosis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Nail disorder
         subjects affected / exposed
    11 / 50 (22.00%)
         occurrences all number
    90
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    36 / 50 (72.00%)
         occurrences all number
    560
    Photosensitivity reaction
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Pigmentation disorder
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    9
    Pruritus
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    23
    Rash
         subjects affected / exposed
    5 / 50 (10.00%)
         occurrences all number
    13
    Skin lesion
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    16 / 50 (32.00%)
         occurrences all number
    76
    Arthritis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    16
    Bone pain
         subjects affected / exposed
    19 / 50 (38.00%)
         occurrences all number
    99
    Chest wall pain
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    5
    Muscle cramp
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    12
    Muscular weakness
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    8
    Myalgia
         subjects affected / exposed
    13 / 50 (26.00%)
         occurrences all number
    52
    Neck pain
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    10 / 50 (20.00%)
         occurrences all number
    12
    Tendonitis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    15
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    36 / 50 (72.00%)
         occurrences all number
    441
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Cystitis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    3
    Eye infection
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    10
    Gastroenteritis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Herpes simplex
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    8
    Influenza
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Localised infection
         subjects affected / exposed
    8 / 50 (16.00%)
         occurrences all number
    15
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    5
    Nasopharyngitis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    4
    Oral candidiasis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    4
    Rhinitis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 50 (18.00%)
         occurrences all number
    17
    Urinary tract infection
         subjects affected / exposed
    5 / 50 (10.00%)
         occurrences all number
    7
    Viral infection
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jun 2005
    Duration of study recruitment period modification: From Q3 2005 in the initial version of the protocol to Q3 2006.
    07 Apr 2014
    XELODA new information added ICF modified and updated NVB AEs reporting IB version updated Declaration of Helsinki updated Sponsor's personnel list updated

    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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