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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2012-000345-12
    Sponsor's Protocol Code Number:ABR-39476
    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:2012-03-29
    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 number2012-000345-12
    A.3Full title of the trial
    A phase II study of gefitinib and fulvestrant in patients with advanced, EGFR mutated non-small cell lung cancer pretreated with reversible EGFR tyrosine kinase inhibitors
    Een Fase II studie van gefitinib en fulvestrant bij patienten met vergevorderd stadium, EGFR-gemuteerd NSCLC die eerder behandeld zijn geweest met tyrosine kinase inhibitors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with gefitinib and fulvestrant in patients with non-small cell lungcancer
    Behandeling met gefitinib en fulvestrant bij patienten met niet-kleincellig longkanker
    A.3.2Name or abbreviated title of the trial where available
    Gefitinib and fulvestrant in NSCLC
    Gefitinib en fulvestrant bij NSCLC
    A.4.1Sponsor's protocol code numberABR-39476
    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 SponsorVU Medical Center
    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 supportVUMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVUMC
    B.5.2Functional name of contact pointEF Smit
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 7057
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1007MB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204444782
    B.5.5Fax number+31204443090
    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 Fulvestrant (faslodex)
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFulvestrant
    D.3.2Product code Fulvestrant
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFULVESTRANT
    D.3.9.1CAS number 129453-61-8
    D.3.9.2Current sponsor codefulvestrant
    D.3.9.3Other descriptive nameFaslodex
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Patients with pathologically documented NSCLC with an EGFR mutation, who failed previous treatment with reversible EGFR TKI’s (gefitinib or erlotinib).
    Patienten met pathologisch bewezen NSCLC met een EGFR mutatie, die progressie kregen onder eerdere behandeling met TKI's.
    E.1.1.1Medical condition in easily understood language
    Advanced stage lungcancer (NSCLC)
    Vergevorderd stadium van longkanker (NSCLC)
    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
    Primary objective: to assess the rate of no progression (NPR) at 8 weeks following treatment of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible TKI’s.
    Primair eindpunt: mate van 'geen progressie' (NPR) vast te stellen 8 weken na de behandeling met gefitinib en fulvestrant in EGFR gemuteerde patiënten die eerder behandeld zijn geweest met reversibele TKI's.
    E.2.2Secondary objectives of the trial
    Secondary objective: to characterize the quantitative and qualitative toxicities of this regimen, duration of response for responding patients and overall survival.
    Secundaire doelstelling: de kwantitatieve en kwalitatieve toxiciteit van deze behandeling, duur van de respons voor patiënten die reageren en de totale overleving
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Correlation of RNA from trombocytes with time to progression and/or overall survival
    Vanuit bloed monsters zal gekeken gaan worden naar RNA van trombocyten wat gecorreleerd zal worden aan tijd-tot-progressie en overall survival
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed NSCLC locally advanced and metastatic disease stage IIIB and IV, that have an activating EGFR mutation, progressive on treatment with gefitinib or erlotinib. Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible
    2. At least one unidimensionally measurable lesion meeting RECIST criteria
    3. ECOG PS 0-2
    4. Age > 18 years
    5. Adequate organ function, including:
    a. Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
    b. Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 3.0 x ULN
    AP, ALT, and AST <5 xULN is acceptable if the liver has tumour involvement
    c. Renal: calculated creatinine clearance > 45 ml/min based on the Cockroft and Gault formula.
    6. Signed informed consent
    7. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 14 days prior to study enrollment.
    8. Estimated life expectancy >12 weeks.
    9. Patient compliance and geographical proximity that allow adequate follow up.
    10. NSCLC with an activating sensitising EGFR TK mutation as determined by using a well-validated and robust methodology.
    1. Histologisch of cytologisch bevestigd NSCLC, lokaal gevorderde of gemetastaseerde ziekte stadium IIIB en IV, met een activerende EGFR-mutatie, die progressief op behandeling met erlotinib en gefitinib hadden. Patiënten met onbekende mutatie status die met deze middelen respons of stabiele ziekte hebben laten zien gedurende tenminstens zes maanden met behandeling met erlotinib en gefitinib, komen ook in aanmerking
    2. Ten minste een unidimensionale, meetbare laesie volgens RECIST criteria
    3. ECOG PS 0-2
    4. Leeftijd> 18 jaar
    5. Een adequate orgaanfunctie, waaronder:
    a. Adequate beenmerg reserve: ANC> 1,5 x 109 / L, bloedplaatjes> 100 x 109 / L.
    b. Lever: bilirubine <1,5 x ULN, AP, ALT, AST <3,0 x ULN
    AP, ALT en AST <5 xULN is aanvaardbaar als de lever bij de tumor betrokken
    c. Nier: berekende creatinineklaring> 45 ml / min op basis van de Cockroft en Gault formule.
    6. Getekend informed consent
    7. Mannelijke en vrouwelijke patiënten in de vruchtbare levensfase moeten gebruik maken van een goedgekeurd voorbehoedsmiddel, indien van toepassing. Vrouwelijke patiënten in de vruchtbare leeftijd moeten een negatieve zwangerschapstest serum binnen 14 dagen voorafgaand aan de studie inschrijving.
    8. Geschatte levensverwachting> 12 weken.
    9. Therapietrouw en de geografische nabijheid die adequate follow-up mogelijk maken.
    10. NSCLC met een activerende sensibiliserende EGFR mutatie TK, zoals bepaald door het gebruik van een goed gevalideerde en robuuste methodologie.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women
    2. Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection.
    3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
    4. Concomitant treatment with any other experimental drug under investigation.
    5. Known severe hypersensitivity to gefitinib or any of the excipients of the product.
    6. Presence of EGFR TK mutation reported to confer resistance to EGFR TKI: i.e., exon 20 point mutation (T790M or S768I EGFR) or exon 20 insertion as determined by using a well-validated and robust methodology.
    7. 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.
    8. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
    9. Previous enrolment or treatment in the present study.
    1. Zwangere vrouwen of vrouwen die borstvoeding geven
    2. Patiënten die een hoog medisch risico hebben als gevolg van niet-maligne aandoeningen evenals patienten met een actieve ongecontroleerde infectie.
    3. Gedocumenteerd hersenmetastasen, tenzij de patiënt lokale therapie heeft afgerond voor hersenmetastasen en is geen corticosteroïden meer heeft gebruikt gedurende ten minste twee weken voor de inschrijving.
    4. Gelijktijdige behandeling met ander experimenteel medicijn in onderzoeksverband.
    5. Bekende ernstige overgevoeligheid voor gefitinib of voor een van de hulpstoffen van het product.
    6. De aanwezigheid van de EGFR-mutatie TK gerapporteerd aan resistentie tegen EGFR TKI: dat wil zeggen, exon 20 puntmutatie (T790M of S768I-EGFR) of exon 20 insertie, bepaald door het gebruik van een goed gevalideerde en robuuste methodologie.
    7. Medische voorgeschiedenis van interstitiële longziekte, drug-geïnduceerde interstitiële ziekte, straling pneumonitis welke behandeling met steroïden of enig bewijs van klinisch actief interstitiële longziekte vereist.
    8. Gelijktijdig gebruik van bekende CYP3A4-inductoren zoals fenytoïne, carbamazepine, rifampicine, barbituraten of sint-janskruid.
    9. Eerdere inschrijving of behandeling in de huidige studie.
    E.5 End points
    E.5.1Primary end point(s)
    rate of no progression (NPR) at 8 weeks
    Mate van 'geen progressie' na 8 weken
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 weken
    E.5.2Secondary end point(s)
    - Quantitative and qualitative toxicities of this regimen
    - Duration of response for responding patients
    - Time to progression or death
    - Progression free survival
    - Overall survival
    - Kwantitatieve en kwalitatieve toxiciteit van dit regime
    - Duur van de respons voor patiënten die reageren
    - De tijd tot progressie of overlijden
    - Progressievrije overleving
    - Algehele overleving
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks, every 4 weeks and at disease progression
    na 4 en 8 weken en bij ziekte progressie
    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 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.7.1.3.1Other 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 study will be terminated after every patient had a follow up of at least 6 months.
    Studie zal worden beeindigd als elke patient 6 maanden follow-up heeft gehad.
    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 months6
    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: 48
    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 state48
    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)
    Not different from the expected normal treatment
    Niet verschillend van normale behandeling
    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 Decision2012-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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