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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-005272-34
    Sponsor's Protocol Code Number:42703
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-01-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005272-34
    A.3Full title of the trial
    Iressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment.
    Het opnieuw geven van Iressa in EGFR-gemuteerde patienten die reeds eerder behandeld zijn geweest met een EGFR-TKI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Re-administration of Iressa to EGFR-mutated NSCLC patients who were eralier treated succesfully with an EGFR-TKI and a subsequent treatment
    Het opnieuw geven van Iressa aan niet-kleincellig longkanker patienten met een EGFR-mutatie, die eerder al met goed resultaat behandeld zijn met een tyrosine kinase inhibitor en een volgende behandeling
    A.3.2Name or abbreviated title of the trial where available
    IRENE
    IRENE
    A.4.1Sponsor's protocol code number42703
    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 SponsorNederlandse Vereniging van Artsen voor Longziekten en Tuberculose NVALT
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNVALT
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNVALT
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressLuijbenstraat 15
    B.5.3.2Town/ cityDen Bosch
    B.5.3.3Post code5211 BR
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31736126163na
    B.5.5Fax numbernananana
    B.5.6E-mailef.smit@vumc.nl
    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.2.1.1.1Trade name Gefitinib
    D.2.1.1.2Name of the Marketing Authorisation holderAStra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameIressa
    D.3.2Product code 13166
    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 INNIressa
    D.3.9.1CAS number 184475-35-2
    D.3.9.3Other descriptive nameGEFITINIB
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    niet kleincellig longkanker
    E.1.1.1Medical condition in easily understood language
    lung cancer
    longkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Disease control rate
    Disease control rate
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are: objective response rate (ORR) according to RECIST, progression free survival (PFS) according to RECIST, overall Survival (OS), EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis and the association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed.
    PFS
    OS
    EGFR mutatie status
    Correlatie VeriStrat en OS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK mutation as determined before starting the first EGFR-TKI treatment by using a well-validated and robust methodology
    2. 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 an EGFR-TKI with a documented complete (CR) or partial response (PR) or stable disease (SD) >12 weeks as the best response to their 1st EGFR-TKI treatment and who have received any subsequent anti-cancer therapy (excluding EGFR-TKIs) treatment, including but not limited to doublet platinum based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy, on which they progressed.
    3. 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.
    4. WHO / ECOG / Zubrod performance status 0-2.
    5. Possibility of obtaining tumour material before the start of the study treatment.
    1. Histologisch of cytologisch bevestigd NSCLC met een activerende EGFR TK mutatie, zoals bepaald voor aanvang van de eerste EGFR-TKI behandeling met behulp van een gevalideerde methode
    2. Vrouwelijke of mannelijke patiënten van 18 jaar of ouder met lokaal uitgebreid stadium IIIB ziekte die niet in aanmerking komen voor curatieve behandeling of stadium IV (gemetastaseerde) ziekte, die reeds eerder met een tyrosine kinase gevolgd door een volgende (niet-TKI)- behandeling zijn behandeld.
    3. Meetbare ziekte gedefinieerd als ten minste een laesie, niet eerder bestraald, die nauwkeurig kan worden gemeten bij aanvang ≥ 10 mm in de langste diameter (behalve lymfklieren die korte as ≥ 15 mm moet zijn) met een spiraalvormige CT of MRI en geschikt voor nauwkeurige herhaalde metingen.
    4. WHO / ECOG / Zubrod performance status 0-2.
    5. Beschikbaarheid van tumormateriaal voor aanvang van de studie behandeling.
    E.4Principal exclusion criteria
    1. Known severe hypersensitivity to gefitinib or any of the excipients of the product
    2. 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. Previous adjuvant chemotherapy is allowed.
    3. Progressive disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with an EGFR-TKI
    4. Consideration to require radiotherapy to the lung at the time of study entry or in the near future
    5. 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. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline
    6. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation.
    7. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
    8. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
    9. Pregnancy or breast-feeding
    10. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
    11. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
    12. Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of basal cell carcinoma or cervical cancer in situ
    13. Life expectancy of less than 12 weeks
    14. Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
    15. Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site)
    16. Previous enrolment or treatment in the present study.
    1. Bekende, ernstige overgevoeligheid voor gefitinib of voor een van de hulpstoffen van het product
    2. Voorafgaand chirurgie of radiotherapie moeten meer dan 6 maanden voor aanvang van de studie hebben plaatsgevonden. Palliatieve radiotherapie moet ten minste 4 weken voor aanvang van de studie plasats hebben gevonden, zonder blijvende stralingstoxiciteit. Eerdere adjuvante chemotherapie is toegestaan.
    3. Progressieve ziekte of stabiele ziekte (SD) <12 weken als respons op de 1ste lijn behandeling met een EGFR-TKI
    4. Overweging van bestralen in de nabije toekomst
    5. Verleden van interstitiële longziekte, drug-geïnduceerde interstitiële aandoeningen, pneumonitis door bestraling die behandeling met steroïden of een bewijs van klinisch actieve interstitiële longziekte vereist. Reeds bestaande idiopathische longfibrose blijkt uit CT-scan bij baseline
    6. Bekende of vermoedelijke hersenmetastasen of compressie van het ruggenmerg, tenzij behandeld met chirurgie en / of bestraling.
    7. Elke onopgeloste chronische toxiciteit groter is dan CTC graad 2 van een vorige behandeling
    8. Gelijktijdig gebruik van bekende CYP3A4-inductoren, zoals fenytoïne, carbamazepine, rifampicine, barbituraten of sint-janskruid
    9. Zwangerschap of borstvoeding geven
    10. Zoals beoordeeld door de onderzoeker, enig bewijs van ernstige of ongecontroleerde systemische ziekte (bv. instabiele of niet-gecompenseerde ademhaling, hart, lever-of nierziekte)
    11. Aanwijzingen voor andere klinisch significante problemen of laboratoriumafwijkingen waardoor het ongewenst dat de patiënt participeert in de studie
    12. Andere maligniteiten vastgesteld binnen de afgelopen 2 jaar, met uitzondering van basaalcelcarcinoom of baarmoederhalskanker in situ
    13. Levensverwachting van minder dan 12 weken
    14. Behandeling met een niet-goedgekeurde of experimentele geneesmiddel binnen 30 dagen voor dag 1 van de studiebehandeling
    15. Betrokkenheid bij de planning en / of uitvoering van het onderzoek (geldt zowel voor NVALT personeel als voor personeel van de studie)
    16. Eerdere inschrijving of behandeling in de huidige studie.
    E.5 End points
    E.5.1Primary end point(s)
    Disease control rate
    Disease control rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease control rate - end of study
    Disease control rate - einde v studie
    E.5.2Secondary end point(s)
    The secondary objectives of the study are: objective response rate (ORR) according to RECIST, progression free survival (PFS) according to RECIST, overall Survival (OS), EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis and the association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed.
    De secundaire doelstellingen van de studie zijn:
    - objectieve responspercentage (ORR) volgens RECIST
    - progressievrije overleving (PFS) volgens RECIST
    - de totale overleving (OS)
    - EGFR Mutatie-status van tumorweefsel op zowel activerende als resistentie mutatie analyse
    - correlatie tussen de Veristrat assay (Biodesix) en zowel PFS als OS zal worden beoordeeld.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Objective response rate (ORR) according to RECIST - end of study
    Progression free survival (PFS) according to RECIST - end of study
    Overall Survival (OS) - end of study
    EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis - at baseline and at progression
    Association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed - End of study
    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 Yes
    E.6.4Safety No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned24
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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.1.1.1In 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: 92
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state92
    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)
    None
    Geen
    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 Decision2013-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-28
    P. End of Trial
    P.End of Trial StatusOngoing
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