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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2011-005157-31
    Sponsor's Protocol Code Number:D7913L00138
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-08
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005157-31
    A.3Full title of the trial
    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
    Studio di fase II in aperto, multicentrico, a singolo braccio per indagare l'efficacia, la sicurezza e la tollerabilita' di Gefitinib 250 mg (IRESSA) come trattamento ri-sfida in pazienti che hanno tumore al polmone non a piccole cellule (NSCLC) localmente avanzato o metastatico positivo alla mutazione del Recettore del Fattore di Crescita Epidermico (EGFR) e che hanno precedentemente risposto al gefitinib e ricevuto successiva chemioterapia o altra terapia anticancro ad eccezione di inibitori tirosin chinasici di EGFR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as treatment re-challenge in Patients, who have Non-Small Cell Lung Cancer (NSCLC)
    Studio per indagare l’efficacia, la sicurezza e la tollerabilita' di Gefitinib 250 mg (IRESSA™) come trattamento ri-sfida in pazienti che hanno tumore al polmone non a piccole cellule (NSCLC)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD7913L00138
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTRAZENECA
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportc
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASTRAZENECA SPA
    B.5.2Functional name of contact pointASTRAZENECA SPA
    B.5.3 Address:
    B.5.3.2Town/ cityBASIGLIO
    B.5.3.3Post code20080
    B.5.4Telephone number029801 1
    B.5.5Fax number029801 1
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name IRESSA*30CPR RIV 250MG
    D. of the Marketing Authorisation holderASTRAZENECA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEFITINIB
    D.3.9.1CAS number 184475-35-2
    D.3.9.2Current sponsor codeZD1839
    D.3.9.4EV Substance CodeSUB20637
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non small cell lung cancer
    Tumore polmonare non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Non small cell lung cancer
    Tumore polmonare non a piccole cellule
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterise the impact of gefitinib on the
    Response Evaluation Criteria in Solid
    Tumours (RECIST) based assessments;
    objective response rate (ORR ; confirmed
    complete response(CR) or partial response
    (PR)) and disease control rate (DCR;
    confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC
    Valutare il Tasso di Controllo di Malattia (DCR; risposta completa (CR) o risposta parziale (PR) o malattia stabile (SD)) a gefitinib utilizzando i criteri di valutazione “Response Evaluation Criteria in Solid Tumours” (RECIST) versione 1.1 nei pazienti con NSCLC EGFR M+
    E.2.2Secondary objectives of the trial
    - To characterise the impact of gefitinib on
    progression free survival according to
    RECIST, in patients with EGFR M+ NSCLC
    - To characterise the impact of gefitinib on
    progression free survival according to clinical criteria, in patients with EGFR M+ NSCLC
    - To characterise the impact of gefitinib on Duration of therapy, in patients with EGFR M+ NSCLC
    - To characterise the impact of gefitinib on overall survival in patients with EGFR M+ NSCLC, in patients with EGFR M+ NSCLC
    - To characterise the safety profile of gefitinib in patients with EGFR M+ NSCLC
    - Valutare il Tasso di Risposta Obiettiva (ORR; risposta complete (CR) o risposta parziale (PR)), sopravvivenza libera da progressione in accordo ai RECIST, sopravvivenza libera da progressione in accordo ai criteri clinici, durata della terapia e sopravvivenza in pazienti con EGFR M+ NSCLC
    - Valutare il profilo di sicurezza di gefitinib in pazienti con EGFR M+ NSCLC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of informed consent prior to any study specific procedures
    2. Histologically or cytologically confirmed NSCLC with an activating sensitising
    EGFR TK mutation as it was determined before starting the first gefitinib treatment
    by using a well-validated and robust methodology: adenocarcinoma, including
    Bronchoalveolar Carcinoma (BAC), squamous cell carcinoma, large cell carcinoma,
    adenosquamous carcinoma or undifferentiated carcinoma or not-otherwise specified
    3. Female or male patients aged 18 years or over with Locally advanced or metastatic
    stage IIIB/IV disease, not suitable for therapy of curative intent or stage IV
    (metastatic) disease, eligible for gefitinib re-challenge treatment for NSCLC who
    have already received gefitinib with a documented complete (CR) or partial
    response (PR) or stable disease (SD) >12 weeks as the best response to their 1st
    gefitinib treatment and progressing during or after a subsequent anti-cancer therapy
    (excluding EGFR-TKIs) treatment, including but not limited to doublet platinum
    based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy.
    4. Measurable disease defined as at least one lesion, 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.
    5. WHO / ECOG / Zubrod performance status 0-2.
    1. Firma del Consenso Informato prima di qualsiasi procedura di studio
    2. NSCLC confermato istologicamente o mitologicamente con mutazione attivante di sensibilità nel dominio tirosin chinasico del gene EGFR come determinate prima dell’inizio del primo trattamento con gefitinib usando una metodologia robusta e ben validate: adenocarcinoma, includendo il carcinoma broncoalveolare (BAC), carcinoma cellular squamoso, carcinoma a grandi cellule, carcinoma adenosquamoso o carcinoma non differenziato o NSCLC non altrimenti specificato.
    3. Pazienti maschi o femmine di età maggiore o uguale a 18 anni con malattia localmente avanzata o metastatica di stadio IIIB/IV, non adatti a terapia di intento curative o malattia di stadio IV (metastatica), elegibili per il trattamento re-challenge con gefitinib per il NSCLC che hanno già ricevuto gefitinib con una documentata risposta complete (CR) o risposta parziale (PR) o malattia stabile (SD) &gt;12 settimane come miglior risposta al loro primo trattamento con gefitinib e che hanno ricevuto una successiva terapia anti-tumorale (escludendo inibitori tirosinchinasici dell’EGFR), includendo ma non limitato alla chemioterapia basata su doppietta di platino o ionoterapia con docetaxel o ionoterapia con pemetrexed.
    4. Malattia misurabile definite come almeno una lesione, non precedentemente irradiate, che può essere accuratamente misurata al baseline come ≥ 10 mm nel diametro più lungo (ad eccezione dei linfonodi che devono avere l’asse corto ≥ 15 mm) con CT spirale o MRI e che sia adatto per misure accurate e ripetute.
    5. WHO / ECOG / Zubrod performance status 0-2.
    E.4Principal exclusion criteria
    1. Known severe hypersensitivity to gefitinib or any of the excipients of the product
    Prior EGFR TKIs except gefitinib followed by subsequent anti-cancer treatment
    (including chemotherapy and excluding EGFR-TKIs). Previous adjuvant
    chemotherapy is allowed. Prior surgery or radiotherapy must be completed more
    than 6 months before start of study treatment. Palliative radiotherapy must be
    completed at least 4 weeks before start of study treatment with no persistent
    radiation toxicity.
    3. Progression disease or stable disease (SD) <12 weeks as best response to the 1st line
    treatment with gefitinib
    4. Not progressing during or after the last anti-cancer treatment.
    5. Considered to require radiotherapy to the lung at the time of study entry or in the
    near future
    6. Past medical history of interstitial lung disease, drug-induced interstitial disease,
    radiation pneumonitis which required steroid treatment or any evidence of clinically
    active interstitial lung disease
    7. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline
    8. Insufficient lung function as determined by either clinical examination or an arterial
    oxygen tension (PaO2) of < 70 Torr
    9. Known or suspected brain metastases or spinal cord compression, unless treated
    with surgery and/or radiation and stable without steroid treatment for at least 4
    weeks prior to the first dose of study medication
    10. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
    11. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine,
    rifampicin, barbiturates, or St John's Wort
    12. Pregnancy or breast-feeding
    13. As judged by the investigator, any evidence of severe or uncontrolled systemic
    disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal
    14. Evidence of any other significant clinical disorder or laboratory finding that makes
    it undesirable for the patient to participate in the study
    15. Other co-existing malignancies or malignancies diagnosed within the last 5 years
    with the exception of basal cell carcinoma or cervical cancer in situ
    16. Life expectancy of less than 12 weeks
    17. Treatment with a non-approved or investigational drug within 30 days before Day 1
    of study treatment
    18. Involvement in the planning and/or conduct of the study (applies to both
    AstraZeneca staff and/or staff at the study site)
    19. Previous enrolment or treatment in the present study.
    1. Conosciuta severa ipersensibilità a gefitinib o a qualche eccipiente del prodotto.
    2. Trattamento precedente con inibitori tirosinchinasici dell’EGFR eccetto gefitinib seguito da conseguente trattamento anti-tumorale (includendo la chemioterapia ed escludendo inibitori tirosinchinasici dell’EGFR. Una precedente chemioterapia adiuvante è permessa. Precedente chirurgia o radioterapia deve essere stata completata più di 6 mesi prima dell’inizio del trattamento di studio. La radioterapia palliativa deve essere completata almeno 4 settimane prima dell’inizio del trattamento di studio con tossicità alle radiazioni non persistente. Progressione di malattia o malattia stabile (SD) &lt;12 settimane come migliore risposta al primo trattamento con gefitinib.
    3. Pazienti che richiedono radioterapia la polmone al momento dell’entrata nello studio o nel future prossimo.
    4. Storia medica passata di malattia intersiziale del polmone, malattia intersiziale indotta da farmaco, malattia intersiziale, polmonite da radiazioni che richiede trattamento con steroidi o qualsiasi evidenza di malattia interstiziale del polmone clinicamente attiva.
    5. Fibrosi polmonare idiopatica pre-esistente evidenziata da CT scan al baseline.
    6. Insufficiente funzione polmonare come determinato da esame clinic o tensione di ossigeno arterioso (PaO2) &lt; 70 Torr.
    7. Conosciute o sospette metastasi cerebrali o compression alla colonna vertebrale, a meno che non trattate con chirurgia e/o radiazioni e stabili senza il trattamento con steroidi per almeno 4 settimane prima della prima dose del farmaco di studio.
    8. Qualsiasi tossicità cronica non risolta di grado CTC &gt;2 dalla precedente terapia anti-tumorale.
    9. Uso concomitatnte di induttori conosciuti del CYP 3A4 come fenitoina, carbamazepina, rifampicina, barbiturici e Erba di San Giovanni.
    10. Donne in gravidanza o in allattamento
    11. A giudizio degli sperimentatori, qualsiasi evidenza di malattia sistemica severa o non controllata (es. malattie respiratorie, cardiache, epatiche o renali instabili o non compensate).
    12. Evidenza di quasiasi altro disordine clinic o esame di laboratorio che rende inadatta la partecipazione del paziente allo studio
    13. Altri tumori maligni coesistenti o diagnosticati negli ultimo 5 anni, ad eccezione del carcinoma cellular basale o del tumore cervical in situ.
    14. Aspettativa di vita di meno di 12 settimane.
    15. Trattamento con un farmaco sperimentale non approvato nei 30 giorni precedenti l’inizio dell’assunzione del farmaco in studio.
    16. Coinvolgimento nella pianificazione e/o conduzione dello studio (si applica sia allo staff AstraZeneca sia allo staff del centro sperimentale).
    17. Precedente arruolamento o trattamento in questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    E.5.1.1Timepoint(s) of evaluation of this end point
    E.5.2Secondary end point(s)
    E.5.2.1Timepoint(s) of evaluation of this end point
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned28
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the data cut-off which will be 6 months after the last patient has started study treatment.
    La fine dello studio è definita come il data cut-off che sarà 6 mesi dopo l'inizio del trattamento dell'ultimo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state108
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Provision will be made for patients who have not progressed at the
    time of the data cut-off and have benefit from the study drug to continue to be treated with
    gefitinib outside this Clinical Study Protocol (eg, named patient program or other supply).
    I pazienti che al momento del data cut-off non sono in progressione e hanno tratto beneficio dal farmaco in studio continueranno ad essere trattati con gefitinib al di fuori del protocollo di studio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-31
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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