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    Clinical Trial Results:
    A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as treatment re-challenge in Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and who previously responded to gefitinib and received subsequent chemotherapy or other active anti-cancer therapy excluding EGFR-TKIs

    Summary
    EudraCT number
    2011-005157-31
    Trial protocol
    IT  
    Global end of trial date
    09 Jan 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Jun 2016
    First version publication date
    23 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D7913L00138
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca SpA
    Sponsor organisation address
    Via Sforza 5, Milan, Italy, 20080
    Public contact
    Elisa Pastore, AstraZeneca SpA, +39 0298011,
    Scientific contact
    Silvia Ferrari, AstraZeneca SpA, +39 0298015227, silvia.ferrari@astrazeneca.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
    09 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to describe Objective response rate (ORR; confirmed complete response (CR) or partial response (PR) as per the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and the disease control rate (CBR; confirmed complete response (CR) or partial response (PR) or stable disease (SD)) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in patients diagnosed for activating sensitising Epidermal Growth Factor mutation positive (EGFR M+) NSCLC.
    Protection of trial subjects
    The Informed Consent Forms was incorporated wording that complies with relevant data protection and privacy legislation. Pursuant to this wording, patients authorised the collection, use and disclosure of their study data by the investigator and by those persons who need that information for the purposes of the study. The Master Informed Consent Forms explained that study data were stored in a computer database, maintaining confidentiality in accordance with national data legislation. All data computer processed by AstraZeneca were identified by “E-code”, and study code. AstraZeneca did not provide individual genotype results to patients, any insurance company, any employer, their family members, general physician or any other third party, unless required to do so by the law. Extra precautions were taken to preserve confidentiality and prevent study data being linked to the identity of the patient. In exceptional circumstances, however, certain individuals might see both the study data and the personal identifiers of a patient. For example, in the case of a medical emergency, an AstraZeneca Physician or an investigator might know a patient’s identity and also have access to his or her study data. Also Regulatory authorities may require access to the relevant files.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    21
    From 65 to 84 years
    39
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Investigator had to obtain signed informed consent from the potential patient before any study specific procedures are performed. He/she determined patient eligibility and assigned potential patient with a unique identification number. He/she recorded enrolment date for patients who were eligible for the study in the eCRF at screening Visit.

    Pre-assignment period milestones
    Number of subjects started
    61
    Number of subjects completed
    61

    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    Gefitinib
    Arm description
    Gefitinib 250 mg in oral tablet form administered once daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Gefitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefitinib 250 mg in oral tablet form will be administered once daily.

    Number of subjects in period 1
    Gefitinib
    Started
    61
    Completed
    61
    Period 2
    Period 2 title
    Open label phase
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    Gefitinib
    Arm description
    Gefitinib 250 mg in oral tablet form administered once daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Gefitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Gefitinib 250 mg in oral tablet form will be administered once daily.

    Number of subjects in period 2
    Gefitinib
    Started
    61
    Completed
    10
    Not completed
    51
         Progressive disease (47), Other reason (1)
    48
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gefitinib
    Reporting group description
    Gefitinib 250 mg in oral tablet form administered once daily.

    Reporting group values
    Gefitinib Total
    Number of subjects
    61 61
    Age Categorical
    Patient's age calculated at screening visit
    Units: Subjects
        Adults (18-64 years)
    21 21
        From 65-84 years
    39 39
        85 years and over
    1 1
    Age Continuous
    Patient's age calculated at screening visit
    Units: years
        arithmetic mean (standard deviation)
    66.9 ± 10.1 -
    Gender Categorical
    Units: Subjects
        Female
    45 45
        Male
    16 16
    Subject analysis sets

    Subject analysis set title
    Gefitinib
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All enrolled patients

    Subject analysis sets values
    Gefitinib
    Number of subjects
    61
    Age Categorical
    Patient's age calculated at screening visit
    Units: Subjects
        Adults (18-64 years)
    21
        From 65-84 years
    39
        85 years and over
    1
    Age Continuous
    Patient's age calculated at screening visit
    Units: years
        arithmetic mean (standard deviation)
    66.9 ± 10.1
    Gender Categorical
    Units: Subjects
        Female
    45
        Male
    16

    End points

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    End points reporting groups
    Reporting group title
    Gefitinib
    Reporting group description
    Gefitinib 250 mg in oral tablet form administered once daily.
    Reporting group title
    Gefitinib
    Reporting group description
    Gefitinib 250 mg in oral tablet form administered once daily.

    Subject analysis set title
    Gefitinib
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All enrolled patients

    Primary: Objective Response Rate

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    End point title
    Objective Response Rate [1]
    End point description
    ORR is the sum of CR and PR
    End point type
    Primary
    End point timeframe
    Overall Study
    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 analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    End point values
    Gefitinib Gefitinib
    Number of subjects analysed
    61 [2]
    61 [3]
    Units: percentage
        number (confidence interval 95%)
    4.9 (1.7 to 13.5)
    4.9 (1.7 to 13.5)
    Notes
    [2] - 3 patients with a response
    [3] - 3 patients with a response
    No statistical analyses for this end point

    Primary: Clinical Benefit Rate

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    End point title
    Clinical Benefit Rate [4]
    End point description
    CBR is the sum of CR, PR and SD
    End point type
    Primary
    End point timeframe
    Overall Study
    Notes
    [4] - 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: Analysis of ORR and CBR was based on frequency analysis (n,%) and 95% CI. I tried to add this info the form "Statsitical analysis" but an additional error appear. The system required the results of a group comparison. The study was a single arm trial.
    End point values
    Gefitinib Gefitinib
    Number of subjects analysed
    61 [5]
    61 [6]
    Units: percentage
        number (confidence interval 95%)
    52.5 (40.2 to 64.5)
    52.5 (40.2 to 64.5)
    Notes
    [5] - 32 patients with CBR
    [6] - 32 patients with CBR
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    Progression Free Survival
    End point description
    PFS was calculated as the time from the first dose of gefitinib study treatment until the date of (i) objective disease progression as defined by RECIST 1.1 or (ii) death from any cause in the absence of progression.
    End point type
    Secondary
    End point timeframe
    Overall Study
    End point values
    Gefitinib
    Number of subjects analysed
    61
    Units: Days
        median (confidence interval 95%)
    84 (74 to 94)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    OS was calculated as the time from the first dose of gefitinib study treatment until the date of death from any cause. Any patient not known to have died at the time of data analysis was censored at the time of the last recorded date on which the patient was known to be alive.
    End point type
    Secondary
    End point timeframe
    Overall Study
    End point values
    Gefitinib
    Number of subjects analysed
    61
    Units: Days
        median (confidence interval 95%)
    311 (268 to 431)
    No statistical analyses for this end point

    Secondary: Treatment duration with gefitinib

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    End point title
    Treatment duration with gefitinib
    End point description
    Treatment duration will be calculated from the date of first trial therapy intake to the date of last trial therapy taken.
    End point type
    Secondary
    End point timeframe
    Overall Study
    End point values
    Gefitinib Gefitinib
    Number of subjects analysed
    61
    61
    Units: Days
        median (confidence interval 95%)
    108 (92 to 169)
    108 (92 to 169)
    No statistical analyses for this end point

    Secondary: Time to worsening of disease related symptoms

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    End point title
    Time to worsening of disease related symptoms
    End point description
    Time to worsening of disease-related symptoms based on FACT-L LCS was defined as the interval from the date of enrollment to the first visit response of ‘worsened’ without a subsequent response of ‘improved’ or ‘no change’ within 21 days (or to the last assessment), death due to any cause, or early discontinuation from the study. Time to worsening was censored at the last non-missing assessment visit if the worsening was not observed.
    End point type
    Secondary
    End point timeframe
    Overall Study
    End point values
    Gefitinib
    Number of subjects analysed
    61 [7]
    Units: Days
        median (confidence interval 95%)
    93 (71 to 109)
    Notes
    [7] - Max score on FACT-L is 136.Worsening is defined as a change from baseline in total score <= -6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are those with start date beyond or equal to the informed consent date. Analysis includes adverse events with starting date until 30 days after the last study drug dose intake.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Gefitinib
    Reporting group description
    Gefitinib 250 mg in oral tablet form administered once daily.

    Serious adverse events
    Gefitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 58 (17.24%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 58 (1.72%)
         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 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cognitive disorders
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Gefitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 58 (72.41%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Cough
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    12
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    8
    Chest pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Fatigue
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Pyrexia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    General physical health deterioration
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Gastrointestinal disorders
    Diarrhea NOS
         subjects affected / exposed
    16 / 58 (27.59%)
         occurrences all number
    21
    Vomiting alone
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    11
    Nausea
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    8
    Abdominal pain upper
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    13
    Dry skin
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Pruritus
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Dermatitis acneiform
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    skin toxicity
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Bone pain
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Paronychia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2013
    At the previous text on measurable disease defined as at least one lesion, preferentially not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with spiral CT or MRI and which is suitable for accurate repeated measurements was added that in the presence of only 1 lesion previously irradiated, this can be accepted if a progression of disease has been documented compared with the previous assessment or if the physician considers the modifications of the lesion worthy of a new treatment. Exclusion criteria #9 was modified and steroids were admitted if the purpose of their use was antiedemigenous prophylaxis, in absence of neurological symptoms. Total sample was reduced from 92 pateints to 54 evaluable patients. Statistical methods for analysis were better specified.

    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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