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    Summary
    EudraCT Number:2006-000259-16
    Sponsor's Protocol Code Number:D4200C00057
    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:2007-05-15
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-000259-16
    A.3Full title of the trial
    A phase III, Randomized, Double-Blind, Multi-Centre Parallel-Group Study to Assess the Efficacy of ZD6474 (ZACTIMA) Versus Erlotinib (TARCEVA ) in Patients with Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) after failure of at least One Prior Cytotoxic Chemoterapy
    Studio multicentrico a gruppi paralleli di Fase III randomizzato condotto in doppio cieco, per valutare l'efficacia di ZD6474 (ZACTIMA ) verso Erlotinib (TARCEVA), in pazienti affetti da tumore al polmone non a piccole cellule (NSCLC) localmente avanzato o metastatico (Stadio IIIb-IV) dopo il fallimento di una prima linea di chemioterapia citotossica
    A.4.1Sponsor's protocol code numberD4200C00057
    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.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameZACTIMA
    D.3.2Product code ZD6474
    D.3.4Pharmaceutical form Film-coated 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 INNvandetanib
    D.3.9.2Current sponsor codeZD6474
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number300
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 TARCEVA
    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 INNErlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC)
    Tumore al polmone non a piccole cellule (NSCLC) localmente avanzato o metastatico (Stadio IIIB-IV)
    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
    The primary objective of this study is to demonstrate an improvement in Progression Free
    Survival (PFS) for ZD6474 compared with Erlotinib in patients with locally advanced or
    metastatic NSCLC after failure of at least one but no more than two, prior cytotoxic
    chemotherapy regimens.
    L'obiettivo principale dello studio e' la dimostrazione di un aumento della sopravvivenza libera da progressione (Progression Free Survival PFS) per ZD6474 verso Erlotinib in soggetti con NSCLC localmente avanzato o metastatico dopo fallimento di almeno una ma non piu' di due linee di chemioterapia citotossica.
    E.2.2Secondary objectives of the trial
    1.To demonstrate an improvement in overall survival for ZD6474 compared with Erlotinib
    2.To demonstrate an improvement in the ORR, DCR, and DOR for ZD6474 compared with Erlotinib
    3.To demonstrate an improvement in the time-to-deterioration of pain, dyspnoea,cough in patients treated with ZD6474, compared with Erlotinib, based on the EORTC QLQ-C30 plus lung cancer module QLQ-LC13
    4.To study the safety and tolerability of ZD6474 compared with Erlotinib
    5.To investigate the population pharmacokinetics (PK) of ZD6474 and assess the relationship between PK and QTc, measures of safety and efficacy and pharmacodynamic (PD) biomarkers
    6.To investigate plasma levels of the N-desmethyl and N-oxide metabolites of ZD6474 in this patient population.
    1dimostr di un aumento della sopravvivenza globale per ZD6474 vs Erlotinib. 2dimostr di un aumento della % di risp tumorali obiettive(ORR)(risp completa 'complete response' [CR]+risp parziale 'partial response [PR]),% di controllo della malattia 'disease control rate'(DCR)(CR+PR+stabilita' di malattia 'SD'≥6 sett)e durata della risp 'DOR'secondo i criteri RECIST per ZD6474 verso Erlotinib. 3.La dimostr di un miglioramento in T al deterioramento del dolore,della dispnea e della tosse nei sogg tratt con ZD6474 vs Erlotinib sulla base della valut effettuata con il quest EORTC QLQ-C30 e con il modulo per il tumore polmonare QLQ-LC13 4studio della sicur.e tollerabilita' di ZD6474 verso Erlotinib. 5 studio della PK di ZD6474 e della relazione tra PK e prolungamento dell'intervallo QTc dell'elettrocardiogramma,tra PK e misure di sicur.,tra PK e misure di eff e tra PK e biomarcatori della PD. 6 studio dei livelli plasmatici dei metaboliti di ZD6474 N-desmetil e N-ossido in questa pop di paz
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of informed consent
    2.Female or male aged 18 years and ove
    3.Histologic or cytologic confirmation of locally advanced or metastatic NSCLC(IIIB-IV). Sputum cytology alone is not acceptable. Cytology specimens obtained by brushing, washing, or needle aspiration are acceptable.
    4.Failure of at least one, but no more than two, prior cytotoxic chemotherapy regimens (either radiological documentation of disease progression or due to toxicity).
    5. WHO Performance status 0 - 2
    6.One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria
    7.Negative pregnancy test for women of childbearing potential
    8.Life expectancy of 12 weeks or longer.
    9.Able to read and write
    For inclusion in the genetic research part of the study, patients must fulfil the following criterion:
    10. Provision of informed consent for genetic research and tissue sampling
    If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
    1.Rilascio del Consenso Informato Scritto
    2.Uomini o donne di eta' &#8805; 18 anni
    3.Conferma istologica o citologica, all'ingresso nello studio, di Carcinoma del Polmone Non a Piccole Cellule (NSCLC) localmente avanzato o metastatico (Stadio IIIB- IV). La citologia dell'espettorato non e' considerata accettabile, mentre l'esame citologico ottenuto dal brushing, dal lavaggio bronchiale o dall'ago-aspirato sono considerati accettabili.
    4.Fallimento di almeno una, ma non piu' di due linee di trattamento chemioterapico citotossico (a causa di progressione della malattia documentata radiologicamente o a causa di tossicita').
    5.Performance Status WHO 0-2
    6.Presenza di una o piu' lesioni misurabili con diametro maggiore di almeno 10 mm se misurato con TAC spirale o di 20 mm se misurato con le tecniche convenzionali (in accordo ai criteri RECIST)
    7.Per le donne fertili, test di gravidanza negativo
    8.Aspettativa di vita maggiore di 12 settimane
    9.Paziente in grado di leggere e scrivere
    Per l'inclusione nella parte di ricerca genetica del protocollo, il paziente deve rispettare il seguente criterio di inclusione
    10.Rilascio del consenso informato per la ricerca genetica ed il prelievo di campioni tissutali
    E.4Principal exclusion criteria
    1.Mixed small cell and non small-cell lung cancer histology
    2.Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab[Erbitux] or bevacizumab [Avastin] is permitted)
    3.Chemotherapy or other systemic anti-cancer therapy within 4 weeks before the startof study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
    4.Radiation therapy within 4 weeks before the start of study therapy, not includinglocal palliative radiation. Lesions that have received radiation in the advancedsetting cannot be included as target lesions unless clear tumour progression hasbeen documented in the lesions since the end of radiation therapy
    5.Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
    6.Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy
    7.Serum bilirubin greater than 1.5x upper limit of reference range (ULRR)
    8.Serum creatinine greater than 1.5 x ULRR or creatinine clearance &#8804;50 ml/min (calculated by Cockcroft-Gault formula)
    9.ALT or AST > 2.5 x ULRR if no demonstrable liver metastases, or > 5 x ULRR if judged by the Investigator to be related to liver metastases
    10.Alkaline phosphatase (ALP) > 2.5 x ULRR if no demonstrable liver metastases, or 5 x ULRR if judged by the Investigator to be related to liver metastases
    1.Forme tumorali a istologia mista a piccole cellule e non a piccole cellule
    2.Precedente terapia con farmaci inibitori della tirosina chinasi del recettore del fattore di crescita epidermoidale (EGFR) o del recettore del fattore di crescita vascolare endoteliale (VEGFR) (e' consentito il precedente trattamento con gli anticorpi monoclonali cetuximab [Erbitux] o bevacizumab [Avastin])
    3.Ultima somministrazione del trattamento chemioterapico o di altra terapia sistemica antitumorale assunta meno di 4 settimane prima dell'inizio della terapia di studio (per nitrosouree, mitomicina e suramina 6 settimane)
    4.Ultima somministrazione di radioterapia effettuata meno di 4 settimane prima dell'inizio della terapia di studio, ad esclusione la radioterapia locale a scopo palliativo
    5.Interventi di chirurgia maggiore entro 4 settimane o incompleta cicatrizzazione delle ferite chirurgiche
    6.Presenza di qualsiasi tossicita' di grado (CTCAE) &gt;2 correlata alla precedente terapia antitumorale
    7.Bilirubina serica &gt; 1.5 volte il limite superiore dei valori di riferimento
    8.Creatinina serica &gt; 1.5 volte il limite superiore dei valori di riferimento o Clearance della Creatinina &#8804; 50mL/min (calcolata con la formula di Cockcroft-Gault)
    9.ALT o AST maggiori di 2.5 volte il limite superiore dei valori di riferimento in assenza di mestastasi epatiche documentate o maggiori di 5 volte il limite superiore dei valori di riferimento se lo Sperimentatore ritiene possibile una correlazione con mestastasi epatiche.
    10.Fosfatasi alcalina maggiore di 2.5 volte il limite superiore dei valori di riferimento in assenza di mestastasi epatiche documentate o maggiore di 5 volte il limite superiore dei valori di riferimento se lo Sperimentatore ritiene possibile una correlazione con mestastasi epatiche.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free-Survival
    Sopravvivenza libera da progressione
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned16
    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 Information not present in EudraCT
    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
    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 months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 385
    F.4.2.2In the whole clinical trial 1150
    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 Decision2007-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-15
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