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    Summary
    EudraCT Number:2020-000377-25
    Sponsor's Protocol Code Number:Debio1143-SCCHN-301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000377-25
    A.3Full title of the trial
    A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for
    definitive chemoradiotherapy (TrilynX)
    Studio di fase 3 randomizzato, in doppio cieco, controllato con placebo, condotto su Debio 1143 in combinazione con chemioterapia a base di platino e radioterapia a intensità modulata con frazionamento standard in pazienti affetti da carcinoma della testa e del collo a cellule squamose localmente avanzato, adatto alla chemioradioterapia definitiva (TrilynX).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in patients with head and neck cancer of Debio 1143 in combination with platinum-based chemotherapy and radiotherapy
    Uno studio clinico su Debio 1143 in combinazione con chemioterapia a base di platino e radioterapia su pazienti affetti da carcinoma della testa e del collo
    A.3.2Name or abbreviated title of the trial where available
    TrilynX
    TrilynX
    A.4.1Sponsor's protocol code numberDebio1143-SCCHN-301
    A.5.4Other Identifiers
    Name:INDNumber:143,330
    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 SponsorDEBIOPHARM INTERNATIONAL S.A.
    B.1.3.4CountrySwitzerland
    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 supportDebiopharm International S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDebiopharm International SA
    B.5.2Functional name of contact pointClinical department
    B.5.3 Address:
    B.5.3.1Street AddressChemin Messidor 5-7
    B.5.3.2Town/ cityLausanne
    B.5.3.3Post code1002
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041213210111
    B.5.5Fax number0041213210169
    B.5.6E-mailClinicalTrials@debiopharm.com
    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 Cisplatin Teva 1 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderTeva GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCisplatin Teva 1mg/ ml
    D.3.2Product code [Not Applicable]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATINO
    D.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive namecisplatin
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 nameDebio 1143
    D.3.2Product code [Debio 1143]
    D.3.4Pharmaceutical form Oral solution
    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 INNDebio 1143
    D.3.9.1CAS number 1071992-99-8
    D.3.9.2Current sponsor codeDebio 1143
    D.3.9.3Other descriptive nameDEBIO 1143
    D.3.9.4EV Substance CodeSUB89776
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 3
    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 Carboplatin Kabi 10mg/ ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCarboplatin Kabi 10mg/ ml
    D.3.2Product code [Not Applicable]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBOPLATINO
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    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 squamous cell carcinoma of the head and neck (SCCHN)
    Carcinoma a cellule squamose localmente avanzato della testa e del collo (SCCHN)
    E.1.1.1Medical condition in easily understood language
    Locally advanced head and neck cancer
    Carcinoma della testa e del collo localmente avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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 demonstrate superior efficacy of Debio 1143 vs placebo when added to CRT in locally advanced SCCHN.
    Dimostrare la superiorità in termini di efficacia di Debio 1143 rispetto a placebo quando aggiunto a CRT nel SCCHN localmente avanzato.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of Debio 1143 compared to placebo when added to CRT according to additional efficacy endpoints.
    - To compare safety, tolerability and treatment compliance of Debio 1143 vs placebo, when added to CRT.
    - To compare the health-related quality of life of Debio 1143 vs placebo when added to CRT using patient-reported outcome questionnaires.
    - Valutare l'efficacia di Debio 1143 rispetto a placebo quando aggiunto a CRT in base a endpoint di efficacia aggiuntivi.
    - Confrontare la sicurezza, la tollerabilità e l'aderenza al trattamento di Debio 1143 rispetto a placebo quando aggiunto a CRT.
    - Confrontare la qualità della vita correlata alla salute di Debio 1143 rispetto a placebo quando aggiunto a CRT utilizzando questionari sugli esiti riferiti dal paziente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to sign written informed consent prior to study screening.
    2. Male or female >= 18 years of age (or based on the country legal age limit for adults) on day of signing the ICF.
    3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
    4. Histologically confirmed diagnosis in previously untreated LA-SCCHN patient (stage III, IVA or IVB according to the American Joint
    Committee on Cancer [AJCC]/TNM Staging System, 8th Ed.) suitable for definitive CRT as defined in the protocol.
    5. Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (CT-scan) or magnetic
    resonance imaging (MRI), based on RECIST v 1.1.
    6. For OPC patients, primary tumors must be HPV-negative as determined by p16 expression using immunohistochemistry (IHC).
    7. Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy or jejunostomy placed.
    8. No hearing loss by clinical assessment.
    9. Peripheral neuropathy < grade 2
    10. Adequate hematologic, renal and hepatic function as defined in the protocol.
    11. Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must have a negative serum
    pregnancy test at screening and must not be breastfeeding. Nonsterilized males who are sexually active with a female partner of
    childbearing potential must agree to use adequate birth control as defined in the protocol from ICF signature to 6 months after the last
    administration of chemotherapy or 3 months after the last dose of Debio 1143/matched placebo, whichever is the latest.
    1. Soggetto disposto a, e in grado di firmare un consenso informato scritto prima dello screening dello studio.
    2. Soggetto di sesso maschile o femminile, di età >=18 anni (o in base al limite di età previsto dalla normativa nazionale per la definizione di soggetto adulto) il giorno della firma del Modulo di consenso informato (ICF).
    3. Stato di validità secondo l’Eastern Cooperative Oncology Group (Gruppo cooperativo orientale di oncologia) (ECOG PS) di 0 o 1.
    4. Diagnosi istologicamente confermata di LA-SCCHN (stadio III, IVA o IVB secondo il Sistema di stadiazione dell’American Joint Committee on Cancer [Comitato americano congiunto sul cancro]/Tumore Linfonodi Metastasi [AJCC/TNM], 8° Ed.) non precedentemente trattato, idoneo a CRT definitiva, come definito da protocollo.
    5. Carico tumorale valutabile (lesioni tumorali misurabili e/o non misurabili) mediante tomografia computerizzata (TC) o risonanza magnetica (RM) secondo i criteri RECIST v1.1.
    6. Per i pazienti con OPC: negatività per HPV dei tumori primari, come determinato in base all’espressione di p16 valutata mediante analisi immunoistochimica.
    7. Soggetto in grado di ingerire liquidi o che dispone di un sondino per alimentazione, un tubo gastrostomico o un tubo digiunostomico adeguatamente funzionante.
    8. Nessuna perdita dell’udito in base alla valutazione clinica.
    9. Neuropatia periferica di grado <2.
    10. Funzione ematologica, renale ed epatica adeguata, come definito da protocollo.
    11. Le donne in età fertile (secondo le raccomandazioni del Clinical Trial Facilitation Group) devono presentare un test di gravidanza sul siero negativo allo screening e non devono allattare al seno. I soggetti di sesso maschile non sottoposti a sterilizzazione e sessualmente attivi con una partner in età fertile devono acconsentire all’uso di preservativo e spermicida dalla firma dell’ICF fino a 6 mesi dopo l’ultima somministrazione di chemioterapia o fino a 3 mesi dopo l’ultima dose di Debio 1143/placebo corrispondente, se questo secondo termine è posteriore.
    E.4Principal exclusion criteria
    1. Primary tumor of nasopharyngeal, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or
    unknown primary site.
    2. Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.).
    3. Prior definitive or adjuvant RT and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or
    any other prior SCCHN systemic treatment, including investigational agents.
    4. Use within 14 days prior to randomization or requirement for ongoing treatment with any drug(s) on the prohibited medication list.
    5. Treatment with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment.
    6. Known history of infection with HIV. If unknown history of HIV, an HIV screening test is to be performed and subjects with positive
    serology for HIV-1/2 must be excluded.
    7. Known chronically active HBV or HCV infection. If unknown status, see further details in the protocol.
    8. Other infections (viral and/or bacterial and/or mycotic) requiring systemic treatment.
    9. Live-attenuated vaccinations within 30 days prior to first investigational treatment administration.
    10. Ongoing uncontrolled infection requiring intravenous antibiotic therapy within 1 week prior to randomization.
    11. Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery that may
    limit oral absorption.
    12. Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional
    support), OR plasmatic albumin <3.0 g/dL.
    13. Active gastrointestinal bleeding, or any other uncontrolled bleeding requiring more than 2 red blood cell transfusions or 4 units of packed
    red blood cells within 4 weeks prior to randomization.
    14. Active uncontrolled inflammatory disease (including rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, severe
    extensive psoriasis) requiring ongoing treatment with anti-TNF medication.
    15. Any concomitant medication known to prolong the QT interval that cannot be discontinued or replaced by safe alternative medication within
    7 days prior to start of treatment.
    16. Impaired cardiovascular function or clinically significant cardiovascular diseases, see further details in the protocol.
    17. Symptomatic pulmonary disease requiring continuous or intermittent oxygen supply.
    18. History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma
    cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ non-muscular
    invasive bladder, cervix and/or uterine carcinomas.
    19. Known contraindication to undergoing positron emission tomography with 2-deoxy-2-[fluorine-18] fluoro-D-glucose (18F-FDG-PET) scans,
    contrast-enhanced MRI or contrast-enhanced CT scans.
    20. Known allergy to Debio 1143, cisplatin or any excipient known to be present in Debio1143 or in the placebo formulation.
    21. Non-compensated or symptomatic liver cirrhosis (Child-Pugh score: B or C).
    22. Any ongoing condition or disorder, before randomization, including drug(s) or alcohol abuse, which in the judgment of the Investigator
    would make the patient inappropriate for entry into the study or precluding his/her ability to comply with study procedures.
    1. Tumore primario della rinofaringe, dei seni paranasali, della cavità nasale od orale, delle ghiandole salivari, della tiroide o paratiroide o della cute, oppure con sede primaria sconosciuta.
    2. Malattia metastatica (stadio IVC secondo il sistema AJCC/TNM, 8° Ed.).
    3. Precedente RT definitiva o adiuvante e/o chirurgia radicale della regione testa-collo che possa pregiudicare il piano di irradiazione del tumore primario, o qualsiasi altro trattamento sistemico precedente per SCCHN, compresi eventuali agenti sperimentali.
    4. Uso entro 14 giorni prima della randomizzazione o necessità di trattamento continuo con uno o più dei farmaci riportati nell’elenco dei farmaci proibiti.
    5. Trattamento con un agente sperimentale o uso di un dispositivo sperimentale entro 4 settimane dalla prima dose di trattamento dello studio.
    6. Anamnesi nota di infezione da virus dell’immunodeficienza umana (HIV). Se l’anamnesi relativa all’esposizione a HIV non è nota, è necessario eseguire un test di screening per HIV; i soggetti con sierologia positiva per HIV-1/2 dovranno essere esclusi.
    7. Anamnesi nota di infezione cronica attiva da virus dell’epatite B (HBV) o virus dell’epatite C (HCV). Se stato non noto, rif. protocollo.
    8. Altre infezioni (virali e/o batteriche e/o micotiche) che richiedano un trattamento sistemico.
    9. Vaccinazioni con vaccini vivi attenuati entro 30 giorni prima della prima somministrazione di trattamento sperimentale.
    10. Infezione non controllata in corso con necessità di terapia antibiotica per via endovenosa entro 1 settimana prima della randomizzazione.
    11. Disturbo gastrointestinale noto con sindrome da malassorbimento clinicamente accertata e intervento di chirurgia gastrointestinale maggiore con possibile limitazione dell’assorbimento orale.
    12. Perdita di peso documentata >10% durante le ultime 4 settimane prima della randomizzazione (salvo adozione di misure adeguate per il supporto nutrizionale) OPPURE albumina plasmatica <3,0 g/dl.
    13. Sanguinamento gastrointestinale attivo o qualsiasi altro sanguinamento non controllato che abbia richiesto più di 2 trasfusioni di globuli rossi o 4 unità di globuli rossi concentrati entro 4 settimane prima della randomizzazione.
    14. Malattia infiammatoria attiva non controllata (tra cui artrite reumatoide, lupus eritematoso sistemico, sindrome di Sjögren, psoriasi estesa grave) che richieda un trattamento continuo con farmaco anti-fattore di necrosi tumorale (TNF).
    15. Qualsiasi farmaco concomitante noto per l’effetto di prolungamento dell’intervallo QT che non possa essere interrotto o sostituito con un farmaco alternativo sicuro entro 7 giorni prima dell’inizio del trattamento.
    16. Funzione cardiovascolare compromessa o malattie cardiovascolari clinicamente significative, vedere
    ulteriori dettagli nel protocollo.
    17. Malattia polmonare sintomatica che richieda la somministrazione continua o intermittente di ossigeno.
    18. Anamnesi di altra malignità entro gli ultimi 3 anni prima della randomizzazione, eccetto tumore cutaneo non melanoma con sede al di fuori della regione testa-collo sottoposto a resezione completa o tumore mammario in stadio I sottoposto a resezione completa o carcinomi in situ della vescica (non muscolo-invasivo), della cervice e/o dell’utero sottoposti a resezione completa.
    19. Controindicazione nota all’esecuzione di scansioni di tomografia ad emissione di positroni con 2 deossi-2-[fluoro-18] fluoro-D-glucosio (18F-FDG-PET), RM con mezzo di contrasto o TC con mezzo di contrasto.
    20. Allergia nota a Debio 1143, cisplatino o a qualsiasi eccipiente noto di Debio 1143 o della formulazione placebo.
    21. Cirrosi epatica non compensata o sintomatica (punteggio Child-Pugh: B o C).
    22. Qualsiasi condizione o disturbo in corso, precedente la randomizzazione, compreso l’abuso di alcol o sostanze, che a giudizio dello sperimentatore potrebbe rendere il paziente non idoneo ad accedere allo studio o precluderne la capacità di aderire alle procedure dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Event- Free Survival (EFS) as defined in the protocol.
    Sopravvivenza libera da eventi (EFS) come definita nel protocollo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated in the timepoints listed in the protocol
    Gli endpoint saranno valutati nei punti temporali elencati nel protocollo
    E.5.2Secondary end point(s)
    - Progression-Free Survival (PFS) or death from any cause.
    - Locoregional control as defined in the protocol.
    - Objective response rate.
    - CR rate.
    - Duration of response as defined in the protocol.
    - Overall survival.
    - Proportion of subjects with radical salvage surgery.
    - Time to subsequent systemic cancer treatments.
    - Incidence and severity of adverse events, serious adverse events and adverse events of special interest, changes in laboratory values, vital signs, and electrocardiograms.
    - Extent of exposure of the different treatment agents.
    - Changes from baseline in QOL.
    - Sopravvivenza libera da progressione (PFS) o decesso per qualsiasi causa.
    - Controllo locoregionale come definito dal protocollo.
    - Tasso di risposta obiettiva.
    - Tasso di CR.
    - Durata della risposta come definita dal protocollo.
    - Sopravvivenza complessiva.
    - Percentuale di soggetti sottoposti a chirurgia radicale di salvataggio.
    - Tempo ai successivi trattamenti antitumorali sistemici.
    - Incidenza e gravità degli eventi avversi, degli eventi avversi seri e degli eventi avversi di speciale interesse, variazioni nei valori di laboratorio, segni vitali ed elettrocardiogrammi.
    - Entità dell’esposizione ai diversi agenti terapeutici.
    - Variazioni rispetto al basale nel QOL.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated in the timepoints listed in the protocol
    Gli endpoint saranno valutati nei punti temporali elencati nel protocollo
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Qualità della vita
    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) No
    E.8.2.2Placebo Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Czechia
    France
    Georgia
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Republic of
    Poland
    Portugal
    Russian Federation
    Spain
    Switzerland
    Taiwan
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months9
    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.1.1.1In 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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 337
    F.4.2.2In the whole clinical trial 700
    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
    Nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Gortec
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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