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    Summary
    EudraCT Number:2014-003227-21
    Sponsor's Protocol Code Number:SGC-AX14
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-28
    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 number2014-003227-21
    A.3Full title of the trial
    Phase II study on Inlyta® (axitinib) in recurrent and/or metastatic salivary gland cancers (SGCs) of the upper aerodigestive tract
    Studio di fase 2 con Inlyta® (Axitinib) nel tumore delle ghiandole salivari del tratto aerodigestivo superiore, recidivato e/o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study on Inlyta® (axitinib) in recurrent and/or metastatic salivary gland cancers (SGCs) of the upper aerodigestive tract
    Studio di fase 2 con Inlyta® (Axitinib) nel tumore delle ghiandole salivari del tratto aerodigestivo superiore, recidivato e/o metastatico
    A.4.1Sponsor's protocol code numberSGC-AX14
    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 SponsorFondazione IRCCS Istituto Nazionale dei Tumori Milano
    B.1.3.4CountryItaly
    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 supportFondazione IRCCS Istituto Nazionale dei Tumori Milano
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportPfizer Italy
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Office
    B.5.2Functional name of contact pointPaola Pistillo
    B.5.3 Address:
    B.5.3.1Street Addressvia Giacomo Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number+390223903287
    B.5.5Fax number+390223903353
    B.5.6E-mailpaola.pistillo@istitutotumori.mi.it
    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 Inlyta
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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.3.1Product nameAxitinib
    D.3.2Product code AG-013736
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    recurrent and/or metastatic salivary gland cancers of the upper aerodigestive tract
    tumore delle ghiandole salivari del tratto aerodigestivo superiore, recidivato e/o metastatico
    E.1.1.1Medical condition in easily understood language
    recurrent and/or metastatic salivary gland cancers of the upper aerodigestive tract
    tumore delle ghiandole salivari del tratto aerodigestivo superiore, recidivato e/o metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10051975
    E.1.2Term Salivary gland carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Response Rate according to RECIST criteria 1.1
    Risposta tumorale globale secondo criteri RECIST 1.1
    E.2.2Secondary objectives of the trial
    -Progression free survival
    -Overall survival
    -Duration of response
    -Acute toxicity according to CTCAE v4.0
    -Quality of life (EORTC QLQ-H&N35); EQ-5D
    -Sopravvivenza libera da progressione (PFS)
    -Sopravvivenza globale (OS)
    -Valutazione della durata dell’attività di Axitinib (CR+PR+SD)
    -Valutazione della tossicità di Axitinib secondo criteri CTCAE v4.0
    -Valutazione della qualità di vita (EORTC QLQ-H&N35; EQ-5D)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    We will evaluate whether the molecular profile of the disease influences the activity of the drug. In particular, we will
    sought possible genetic abnormalities of the tumor, such as the expression of the receptors for hormones or growth factors, translocations and other mutations. They will also be collected plasma and saliva samples for future studies.
    Si valuterà se il profilo molecolare della malattia influenza l’attività del farmaco. In particolare saranno
    ricercate possibili anomalie genetiche del tumore, come per esempio l’espressione dei recettori per gli ormoni o fattori di crescita, traslocazioni e altre mutazioni. Inoltre saranno raccolti dei campioni di plasma e saliva per studi futuri.

    E.3Principal inclusion criteria
    -Histologically proven relapsed and/or metastatic salivary gland cancer for which potentially curative options such as surgery or radiotherapy are not indicated
    -Archival tissue samples from primary tumor or metastasis for translational biological research
    -Subjects with at least one measurable target lesion by CT-scan or MRI according to RECIST criteria 1.1 (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions). A previously treated lesion by radiotherapy can be chosen as target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
    -Clinical or radiological progression of disease within 6 months at study entry ; progression of disease by RECIST is not required
    -Age ≥ 18 years
    -ECOG Performance Status < 2
    -Adequate bone marrow, liver and renal function
    -Urinary protein < 2+ by urine dipstick. If dipstick is ≥ 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is < 2 g per 24 hours
    -No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure reading must be ≤140, and the baseline diastolic blood pressure readings must be < 90. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
    - Signed written informed consent
    -Diagnosi di tumore delle ghiandole salivari istologicamente o citologicamente confermata non candidabili a terapia potenzialmente curative, come chirurgia o radioterapia
    -Disponibilità di tessuto tumorale dal tumore primitivo o dalle metastasi per ricerche biologiche
    -Almeno una lesione misurabile secondo criteri RECIST con TAC o RMN (è richiesta progressione di malattia evidente in caso di lesione target unica precedentemente trattata con radioterapia)
    -Progressione clinica o radiologica nei 6 mesi precendenti lo studio. Non è richiesta la progressione secondo i criteri RECIST
    -Età maggiore di 18 anni compiuti
    -Proseguimento della deprivazione androgenica con livelli di testosterone inferiori a 50 ng per decilitro (1.7 nmol per litro)
    -ECOG Performance Status ≤ 2
    -Adeguata funzionalità midollare, epatica e renale
    -Nessuna evidenza di ipertensione non controllata
    -Consenso informato scritto
    E.4Principal exclusion criteria
    -Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
    -Previous systemic therapy for metastatic disease is not allowed (chemotherapy or TKI)
    -History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
    -Known allergic reaction to any of the components of the treatment
    -Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
    -Legal incapacity or limited legal capacity
    -Active clinically serious infections (> grade 2 NCI-CTC version 4.0)
    -Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent
    -Pregnant or breast-feeding patients.
    -Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated < 3 years prior to study entry.
    -Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
    -History of organ allograft.
    -Patients with evidence or history of bleeding diathesis
    -Gastrointestinal abnormalities (i.e. inability to take oral medication; malabsorption syndrome)
    -Requirement for anticoagulant therapy with oral vitamin K antagonists
    -Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
    -Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed)
    -Major surgery within 2 weeks of start of study
    -Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction; patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
    -Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    -Current use or anticipated need for treatment with drugs inhibiting CYP3A4
    -Current use or anticipated need for treatment with drugs inducing CYP3A4 or CYP1A2
    -Pazienti con metastasi encefaliche o meningee a meno che non siano state trattate oltre i 6 mesi, e siano stabili nelle 4 settimane precedenti l’arruolamento
    -Precedenti trattamenti sistemici per malattia ricorrente/metastatica
    -Cardiopatia o vasculopatia clinicamente significativa, quali scompenso cardiaco NYHA III-IV, coronaropatia non controllata, cardiomiopatia o aritmia non controllata, pregresso infarto miocardico nei 6 mesi precedenti, frazione di eiezione del ventricolo sinistro <50% del baseline
    -Reazione allergica nota a uno qualsiasi dei componenti del trattamento
    -Storia di abuso di sostanze, condizioni psicologiche o sociali mediche che possono interferire con la partecipazione del paziente allo studio o valutazione dei risultati dello studio.
    -Incapacità legale o limitata capacità giuridica
    -Infezioni clinicamente gravi attive (> grado 2 NCI-CTC versione 4.0)
    -Condizione medica o psicologica che, a giudizio dello sperimentatore, non consentirebbe al paziente di completare lo studio o firmare il consenso informato
    -Pazienti in gravidanza o in allattamento.
    -Pregressa neoplasia o tumore sincrono in altro sito o altra istologia, eccetto carcinoma cervical in situ, basalioma trattato; tumore vescicale superficiale [Ta, Tis & T1] o qualsiasi altro tumore trattato in maniera curativa < 3 anni prima dell’ingresso in studio.
    -Pazienti con disturbi convulsivi che richiedono farmaci (come gli steroidi o anti-epilettici)
    -Storia di trapianto di organo allogenico
    -Pazienti con evidenza o anamnesi di diatesi emorragica
    -Anomalie gastrointestinali (cioè incapacità di assumere farmaci per via orale, sindrome da malassorbimento)
    -Patologie che richiedano terapia anticoagulante con antagonisti della vitamina K per via orale
    -Chemioterapia o immunoterapia durante lo studio o entro 4 settimane nello studio.
    -Radioterapia durante lo studio o entro 3 settimane dall'inizio del farmaco (Sarà consentita radioterapia palliativa)
    -Chirurgia maggiore entro 2 settimane dall'inizio dello studio
    -Uso di modificatori della risposta biologica, come G-CSF, entro tre settimane dell'ingresso nello studio, pazienti trattati con eritropoietina cronica sono ammessi a condizione che nessun aggiustamento della dose sia condotto entro 2 mesi prima dello studio o durante lo studio
    -Terapia farmacologica sperimentale al di fuori di questo studio durante o entro 4 settimane di ingresso nello studio
    -Uso attuale o necessità già nota di un trattamento con farmaci inibitori o induttori del CYP3A4 e con induttori del CYP1A2
    E.5 End points
    E.5.1Primary end point(s)
    Response Rate according to RECIST criteria 1.1
    Risposta tumorale globale secondo criteri RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 years
    4 anni
    E.5.2Secondary end point(s)
    -Progression free survival
    -Overall survival
    -Duration of response
    -Acute toxicity according to CTCAE v4.0
    -Quality of life (EORTC QLQ-H&N35); EQ-5D
    -Sopravvivenza libera da progressione (PFS)
    -Sopravvivenza globale (OS)
    -Valutazione della durata dell’attività di Axitinib (CR+PR+SD)
    -Valutazione della tossicità di Axitinib secondo criteri CTCAE v4.0
    -Valutazione della qualità di vita (EORTC QLQ-H&N35; EQ-5D)
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 years
    4 anni
    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 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) 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.8.3 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
    LVLS
    Ultima visita per ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state26
    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
    Non applicabile
    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 Decision2014-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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