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    Summary
    EudraCT Number:2011-005820-17
    Sponsor's Protocol Code Number:90111-24111
    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:2012-09-12
    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 number2011-005820-17
    A.3Full title of the trial
    Neoadjuvant afatinib based treatment strategies followed by surgery in squamous cell carcinoma of the head and neck: an EORTC NOCI-HNCG window study.
    Strategie di trattamento neoadiuvante contenenti afatinib seguite da chirurgia per il carcinoma squamocellulare della testa e del collo: Un ''window study'' condotto da EORTC NOCI-HNCG
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neoadjuvant afatinib based treatment strategies followed by surgery in squamous cell carcinoma of the head and neck: an EORTC NOCI-HNCG window study.
    Strategie di trattamento neoadiuvante contenenti afatinib seguite da chirurgia per il carcinoma squamocellulare della testa e del collo: Un ''window study'' condotto da EORTC NOCI-HNCG
    A.3.2Name or abbreviated title of the trial where available
    Neoadjuvant afatinib window study in SCCHN
    A.4.1Sponsor's protocol code number90111-24111
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01538381
    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 SponsorE.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER
    B.1.3.4CountryBelgium
    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 supportBoehringer Ingelheim
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEORTC
    B.5.2Functional name of contact pointProject - Budget & Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street AddressAv E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number003227741679
    B.5.5Fax number003227741030
    B.5.6E-mailregulatory@eortc.be
    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 nameafatinib
    D.3.2Product code NA
    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.3.9.1CAS number 850140-72-6
    D.3.9.4EV Substance CodeSUB32268
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Squamous cell carcinoma of the head and neck (SCCHN)
    Carcinoma squamocellulare della testa e del collo (SCCHN)
    E.1.1.1Medical condition in easily understood language
    Squamous cell carcinoma of the head and neck (SCCHN)
    Carcinoma squamocellulare della testa e del collo (SCCHN)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 is to evaluate the pre operative activity of afatinib as assessed by Fluorodeoxyglucose-Positron emission tomography/computed tomography (FDG-PET/CT).
    L'obiettivo primario è la valutazione dell'attività pre-operatoria di afatinib, valutata mediante FDG-PET/TC (tomografia a emissione di positroni/tomografia computerizzata con fluorodeossiglucosio).
    E.2.2Secondary objectives of the trial
    To evaluate the pre-operative activity and the safety of afatinib in head and neck cancer and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms:
    La valutazione dell'attività pre-operatoria e della sicurezza di afatinib nel carcinoma della testa e del collo e la valutazione delle diverse vie molecolari coinvolte nei meccanismi di risposta e di resistenza del tumore. I risultati di questo studio possono essere usati per condurre una sperimentazione più ampia che ci permetterebbe di confermare o validare le ipotesi generate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Newly diagnosed histologically proven squamous cell carcinoma of the oral cavity; oropharynx; hypopharynx or larynx.
    •Patients selected for a primary surgical treatment.
    •Performance status ECOG 0-1
    Within 2 weeks prior to randomiwation:
    •Adequate bone marrow function
    •Adequate hepatic function times ULN
    •Adequate renal function as demonstrated by serum creatinine
    •Controlled blood pressure
    •Adequate cardiac function
    •FDG PET/CT
    •DCE MRI and DWI MRI performed
    •Primary tumor ≥2 cm in their largest diameter measured bidimensionally by imaging done within 2 weeks prior to randomization
    •Availability of tumor and normal mucosa biopsies during staging endoscopy (please refer to surgical guidelines for further information)
    •Availability of blood samples for Translational research
    •Age ≥18 years
    •Negative pregnancy test
    •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
    •Nuova diagnosi di carcinoma squamocellulare istologicamente confermato della cavità orale, dell'orofaringe , dell'ipolaringe o della laringe.
    •I pazienti con carcinomi della nasofaringe, delle cavità nasali e dei seni paranasali o con carcinoma squamocellulare della testa e del collo (SCCHN) ricorrente/metastatico non sono idonei a questo studio.
    •Sono esclusi gli SCCHN dell'ipofaringe in stadio T3 -T4.
    •Pazienti scelti per un trattamento chirurgico primario.
    •Assenza di metastasi a distanza.
    •Assenza di seconda neoplasia attiva negli ultimi cinque anni, fatta eccezione per il carcinoma della pelle non melanomatoso o il carcinoma in situ della cervice.
    •Performance status secondo ECOG 0-1.
    Nelle 2 settimane precedenti alla randomizzazione:
    •Funzionalità midollare adeguata.
    •Funzionalità epatica adeguata dimostrata volte l'ULN
    •Funzionalità renale adeguata dimostrata da creatinina sierica
    •Funzionalità cardiaca adeguata
    •FDG PET/TC
    •DCE MRI and DWI MRI eseguita
    •Tumore primitivo ≥2 cm nel diametro maggiore, misurato bidimensionalmente mediante esame di imaging eseguito nelle 2 settimane precedenti alla randomizzazione
    •Disponibilità di biopsie del tumore e della mucosa normale ottenute durante l'endoscopia di stadiazione (per ulteriori informazioni fare riferimento alle linee guida chirurgiche)
    •Disponibilità di campioni di sangue per la ricerca biologica
    •Età ≥18 anni
    •Test di gravidanza negativo
    •Prima della registrazione del paziente deve essere ottenuto il consenso informato scritto in conformità alle linee guida dell'ICH di buona pratica clinica e alle normative nazionali/locali
    E.4Principal exclusion criteria
    •Patients with nasopharynx, nasal cavity and paranasal sinuses carcinomas, or recurrent/metastatic SCCHN
    •T3-T4 hypopharyngeal SCCHN
    •No distant metastasis
    •Active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix
    •Prior chemotherapy, radiotherapy or targeted therapy including HER inhibitors (monoclonal antibodies or tyrosine kinase inhibitors) for SCCHN
    •No concomitant use of Potent P-gp inhibitors, Potent P-gp inducers, Erythropoietin (EPO)
    •No evidence of diabetes
    •No evidence of interstitial lung disease
    •No weight loss of more than 10% in the previous 6 months
    •Serious underlying medical conditions which could impair the ability of the patient to participate in the study
    •Participation in another interventional clinical trial in the preceding 30 days prior to randomization
    •I pazienti con rinofaringe, cavità nasali e dei seni paranasali carcinomi, o recidivante / metastatico SCCHN
    •T3-T4 SCCHN ipofaringea
    •No metastasi a distanza
    •Attivo secondo tumore maligno nel corso degli ultimi cinque anni, salvo il cancro della pelle non melanoma o carcinoma in situ della cervice
    •Precedente chemioterapia, radioterapia o terapia mirata compresi i suoi inibitori (anticorpi monoclonali o gli inibitori della tirosin-chinasi) per SCCHN
    •No uso concomitante di potenti inibitori della P-gp, potente P-gp induttori, eritropoietina (EPO)
    •Nessuna evidenza di diabete
    •Nessuna evidenza di malattia polmonare interstiziale
    •Nessuna perdita di peso superiore al 10% nei precedenti 6 mesi
    •Gravi condizioni cliniche di base che possono pregiudicare la capacità del paziente di partecipare allo studio
    •La partecipazione a un altro studio clinico interventistica negli ultimi 30 giorni prima della randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    Metabolic response after 2 weeks of treatment and prior to surgery, assessed by Fluorodeoxyglucose-Positron emission tomography/Computed tomography (FDG-PET/CT) according to EORTC guidelines for response published by Young et al 1999.
    Risposta metabolica dopo 2 settimane di trattamento e prima dell'intervento, valutata con Fluorodeoxyglucose-Positron emissione di positroni / tomografia computerizzata (FDG-PET/TC) secondo le linee guida EORTC per la risposta pubblicati da Young et al 1999.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 2 weeks of treatment and prior to surgery
    Dopo 2 settimane di trattamento e prima dell'intervento
    E.5.2Secondary end point(s)
    -Imaging
    -Surgical safety
    -Translational research
    -Imaging
    -Sicurezza chirurgica
    -Ricerca traslazionale
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Imaging :
    After 2 weeks of treatment and prior to surgery.
    -Surgical safety :
    Up to 4 weeks after surgery.
    -Translational Research :
    Undefined
    -Imaging:
    Dopo 2 settimane di trattamento e prima di un intervento chirurgico.
    -Chirurgica di sicurezza:
    fino a 4 settimane dopo l'intervento.
    -Translational Research:
    Undefined
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Standard di cura (solo intervento chirurgico)
    Standard of care (Surgery only)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard di cura (solo intervento chirurgico)
    Standard of care (Surgery only)
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Four weeks after all patients have had surgery.
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    Fine di studio si verifica quando tutti i criteri seguenti sono state soddisfatte:
    Quattro settimane dopo tutti i pazienti hanno avuto un intervento chirurgico.
    Il processo è maturo per l'analisi dell'endpoint primario così come definito n
    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 months38
    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 months40
    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.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Standard care as per institutional standards / as per the treating
    physician.
    Standard care as per institutional standards / as per the treating
    physician.
    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 Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-28
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