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    Clinical Trial Results:
    Phase II trial of oral vinorelbine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) positive mutation after a failure to treatment with EGFR Tyrosine Kinase Inhibitors (TKI) in first line.

    Summary
    EudraCT number
    2012-003361-18
    Trial protocol
    AT   PL  
    Global end of trial date
    17 Apr 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Feb 2019
    First version publication date
    20 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PM0259CA229J1
    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, Boulogne, France, 92100
    Public contact
    Jean Claude Vedovato, PIERRE FABRE MEDICAMENT, +33 (0)534506870, jean.claude.vedovato@pierre-fabre.com
    Scientific contact
    Jean Claude Vedovato, PIERRE FABRE MEDICAMENT, +33 (0)534506870, jean.claude.vedovato@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
    15 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor.
    Protection of trial subjects
    The study was conducted according to Good Clinical Practice (GCP) (CPMP/ICH/135/95), the principles stated in the Declaration of Helsinki (1964) and its subsequent amendments thereto, and national regulations. The request for authorization by the Competent Authority or its notification (depending on National Regulations) was carried out by the Sponsor. The study protocol and related documents, including the informed consent forms (ICFs), were submitted for approval to independent, local or national Independent Ethics Committees (IECs) and to competent authorities (CAs) before the study set-up, according to national regulations.
    Background therapy
    Oral vinorelbine is a drug with moderate emetogenic risk (emetic risk: 30-90 %). Anti-emetic prophylaxis with oral 5-HT3 antagonists was recommended from the first cycle before each oral vinorelbine intake. The use of corticosteroids as antiemetic was also allowed. 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.
    Evidence for comparator
    No control arm was planned as the study aimed at evaluating the efficacy of oral vinorelbine as a proof of concept in this selected population of patients.
    Actual start date of recruitment
    01 Dec 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety, Ethical reason, Regulatory reason, Scientific research
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Singapore: 8
    Worldwide total number of subjects
    30
    EEA total number of subjects
    22
    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)
    12
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was planned in a total of 55 patients with locally advanced or metastatic EGFR mutation positive NSCLC after failure to 1st line EGFR-TKI therapy and with at least 1 measurable disease . A 2nd cohort was opened to include patients with asymptomatic brain metastases incidentally found during screening process (no local treatment needed).

    Pre-assignment
    Screening details
    Due to a slow recruitment, the Sponsor decided to halt permanently recruitment of patients into the study and terminate the study. Only a total of 30 patients were enrolled, all were eligible and received at least one dose of study treatment.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    ITT Population
    Arm description
    A total of 30 patients were enrolled, all were eligible and received at least one dose of study treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Navelbine
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Oral Vinorelbine was given at 60mg/m2 weekly, for cycle 1, then 80 mg/ m2 weekly for subsequent cycles according to haematological tolerance (a cycle is a treatment period between 3 administrations of weekly oral vinorelbine on day 1, day 8 and day 15). The study treatment was to be continued at least 4 cycles unless documented disease progression, unacceptable toxicity or patient’s refusal. This treatment regimen is within the frame of the market authorization of oral Vinorelbine.

    Number of subjects in period 1
    ITT Population
    Started
    30
    Completed
    0
    Not completed
    30
         Non-drug related toxicity
    3
         Documented progressive disease (radiological)
    20
         Patient's decision to stop
    3
         Drug related toxicity
    2
         Investigator decision (no further benefit expected
    1
         Drug administration delay
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    -

    Reporting group values
    Treatment period Total
    Number of subjects
    30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    12 12
        From 65-84 years
    18 18
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.8 ± 11.8 -
    Gender categorical
    Units: Subjects
        Female
    16 16
        Male
    14 14
    Comorbidities
    Units: Subjects
        <2
    20 20
        ≥2
    10 10
    Smoking History
    Units: Subjects
        Never smoked
    16 16
        Stopped smoking < 10 years
    6 6
        Stopped smoking ≥ 10 years
    8 8
    Primary tumor (histological type)
    Units: Subjects
        Adenocarcinoma
    29 29
        Giant cell carcinoma
    1 1
    Number of metastatic sites at study entry2
    Units: Subjects
        Zero
    2 2
        One
    9 9
        Two
    9 9
        Three
    6 6
        Four
    4 4
    Prior surgery
    Units: Subjects
        Yes
    7 7
        No
    23 23
    Prior radiotherapy
    Units: Subjects
        Yes
    13 13
        No
    17 17
    Prior EGFR targeted therapy
    Units: Subjects
        Gefitinib
    22 22
        Erlotinib
    5 5
        Afatinib
    3 3
    TNM staging at initial diagnosis
    Units: Subjects
        IA
    1 1
        IB
    1 1
        IIIA
    1 1
        IIIB
    4 4
        IV
    23 23
    Best response to prior EGFR-TKI
    Units: Subjects
        Partial Response (PR)
    1 1
        Complete Response (CR)
    16 16
        Stable Disease (SD)
    10 10
        Progressive Disease (PD)
    2 2
        Non -evaluable (NE)
    1 1
    Karnofsky Performance Status
    Units: percentage
        arithmetic mean (standard deviation)
    89.0 ± 8.4 -
    Delay between diagnosis and study entry
    Units: months
        median (full range (min-max))
    12.6 (3.6 to 58.5) -

    End points

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    End points reporting groups
    Reporting group title
    ITT Population
    Reporting group description
    A total of 30 patients were enrolled, all were eligible and received at least one dose of study treatment.

    Primary: Disease control rate (DCR)

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    End point title
    Disease control rate (DCR) [1]
    End point description
    DCR was defined as by Recist v1.1 (CR+PR+SD) rates in the ITT population (all registered and treated patients) with 95% CI calculated following the exact method. Overall, in the ITT population, two PR (N=2/30), one PR not confirmed (SD), and 16 SD were achieved, yielding a DCR of 63.3% [95%CI: 43.8-80.1].
    End point type
    Primary
    End point timeframe
    Tumor assessment was performed at baseline, then every 6 weeks according to RECIST v1.1 until progressive disease documented by the investigator.
    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: No statistical analysis has been specified because the studu is a single-arm study
    End point values
    ITT Population
    Number of subjects analysed
    30
    Units: pourcentage
        number (confidence interval 95%)
    63.3 (43.8 to 80.1)
    No statistical analyses for this end point

    Secondary: Overall response rate

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    End point title
    Overall response rate
    End point description
    Overall Response rate (ORR) was defined as the sum of CR and PR (using the best confirmed response recorded from the date of randomisation to the end of treatment) in the ITT population. There were 2 confirmed PR (N=2/30), and 1 not confirmed PR, yielding an ORR of 6.7%.
    End point type
    Secondary
    End point timeframe
    Overall Response rate (ORR) was evaluated at specified timelines (every 6 weeks until the end of study) in the ITT population by the investigator.
    End point values
    ITT Population
    Number of subjects analysed
    30
    Units: patients
        PD
    11
        SD <24 weeks
    9
        SD ⩾24 weeks
    7
        PR confirmed
    2
        PR not confirmed
    1
    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 disease control rate (sum of confirmed CR, confirmed PR and stabilisation rate) was evaluated for the ITT population using Kaplan Meier curves and Confidence intervals on the median duration of disease control were calculated using the reflected method. Patients who were lost to follow-up without progression, or have 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 occured last. Patients who received a new anti-tumoral treatment, whatever the type of treatment, before their disease progression were censored at the start date of this new anti-tumoral treatment.
    End point type
    Secondary
    End point timeframe
    The duration of disease control (CR, PR and stabilization of at least 3 months) was measured from the date of registration until the criteria for disease progression is met or the date of death or start of new anticancer therapy.
    End point values
    ITT Population
    Number of subjects analysed
    30
    Units: months
        arithmetic mean (full range (min-max))
    5.4 (3.3 to 9.5)
    Attachments
    KM curve of the Duration of Disease Control
    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
    The duration of stable disease was estimated on the ITT population using Kaplan Meier curves and Confidence intervals on the median were calculated using the reflected method. Patients who were lost to follow-up without progression, or reach 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 occur last. Patients who received a new anti-tumoral treatment, whatever the type of treatment, before their disease progression were censored at the start date of this new anti-tumoral treatment.
    End point type
    Secondary
    End point timeframe
    The duration of stable disease was measured from the date of registration until the criteria for disease progression was met or the date of death (whatever the reason of of death) or start of new anticancer therapy.
    End point values
    ITT Population
    Number of subjects analysed
    30
    Units: months
        arithmetic mean (full range (min-max))
    5.0 (3.3 to 9.5)
    Attachments
    Kaplan Meier Stable disease
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    Overall survival (OS)
    End point description
    Analyses of Overall Survival were performed with the Kaplan-Meier method. At the time of data base lock, a total of 24/30 (80%) patients died, all due to disease progression, 4/30 (13.3%) patients were still alive and 2/30 (6.7) patients were lost to follow-up. Overall survival of patients lost to follow-up or without a known record of death was censored at the date of last news.
    End point type
    Secondary
    End point timeframe
    Overall survival was evaluated from the date of registration to the date of death due to any cause in the ITT population.
    End point values
    ITT Population
    Number of subjects analysed
    30
    Units: months
        median (full range (min-max))
    13.1 (6.1 to 15.8)
    Attachments
    Kaplan - Meier Survival time in months
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Each patient was assessed for occurrence of AEs throughout the study period. At the time of the database lock, all patients discontinued study treatment, 24/30 patients died due to disease progression, 4 patients were still alive and 2 were lost to FUP.
    Adverse event reporting additional description
    A total of 166 cycles were administered for a mean number of cycles of 5.5 (± 5.2), with one third (33.3%) of the patients having received at least 6 cycles of the study medication. Approximately one fifth (23.3%) of the patients received > 90% of the planned dose of oral vinorelbine. The median relative dose intensity was 77.6% [range:46.8-105.0].
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    -

    Serious adverse events
    Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 30 (30.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3.3%
    Non-serious adverse events
    Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 30 (93.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    8
    Fatigue
         subjects affected / exposed
    19 / 30 (63.33%)
         occurrences all number
    41
    Pyrexia
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    9
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    14
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    6 / 30 (20.00%)
         occurrences all number
    9
    Respiratory, thoracic and mediastinal disorders
    Bronchopneumopathy
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Bronchospasm
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Cough
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    5
    Dysphonia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    11
    Dyspnoea
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    6
    Pleural effusion
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pleuritic pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    26 / 30 (86.67%)
         occurrences all number
    102
    Febrile neutropenia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Neutropenia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Hypoaesthesia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    17
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Vertigo
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    8 / 30 (26.67%)
         occurrences all number
    15
    Diarrhoea
         subjects affected / exposed
    11 / 30 (36.67%)
         occurrences all number
    15
    Dry mouth
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Gastrointestinal pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    10 / 30 (33.33%)
         occurrences all number
    17
    Pancreatic cyst
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    11 / 30 (36.67%)
         occurrences all number
    12
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    23
    Rash
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    bone pain
         subjects affected / exposed
    8 / 30 (26.67%)
         occurrences all number
    21
    Musculoskeletal pain
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    13
    Osteoporosis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 30 (30.00%)
         occurrences all number
    30
    Gout
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Pneumonia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jul 2013
    Local requirement for performing pregnancy tests to all women of childbearing potential on a regular basis throughout the treatment period (every cycles) Not implemented –Country abandoned (Refusal of study in Dec ,13 by ANMAT Competent Authorities)
    28 Mar 2014
    Inclusion of patients with brain metastases (if asymptomatic and steroid free) in a new cohort of 55 patients Wash out period of 2 weeks for patients previously treated with an approved EGFR-TKI in the frame of a clinical trial, instead of 4 weeks; 2 weeks interval from radiotherapy before starting with oral vinorelbine, instead of 4 weeks. Prolongation of inclusion until Q1 2015

    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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