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    Summary
    EudraCT Number:2014-001274-34
    Sponsor's Protocol Code Number:SG-ABI14
    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:2014-05-08
    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 number2014-001274-34
    A.3Full title of the trial
    Phase II trial of abiraterone acetate in patients with relapsed and/or metastatic, castration resistant, salivary gland cancers.
    Studio di fase II con abiraterone acetato nel paziente con tumore ricorrente/metastatico delle ghiandole salivari resistente al blocco ormonale completo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II trial of abiraterone acetate in patients with relapsed and/or metastatic, castration resistant, salivary gland cancers.
    Studio di fase II con abiraterone acetato nel paziente con tumore ricorrente/metastatico delle ghiandole salivari resistente al blocco ormonale completo.
    A.4.1Sponsor's protocol code numberSG-ABI14
    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
    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
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJanssen-Cilag SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointUfficio Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia G. Venezian 1
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number+390223903287
    B.5.5Fax number+390223903353
    B.5.6E-mailfederica.favales@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 Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL NV
    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 nameAbiraterone Acetato
    D.3.4Pharmaceutical form 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
    relapsed and/or metastatic, castration resistant, salivary gland cancer
    tumore delle ghiandole salivari resistente alla castrazione, ricorrente e/o metastatico
    E.1.1.1Medical condition in easily understood language
    relapsed and/or metastatic, castration resistant, salivary gland cancer
    tumore delle ghiandole salivari resistente alla castrazione, ricorrente 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 10026677
    E.1.2Term Malignant salivary gland cancer
    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
    Tasso di risposta
    E.2.2Secondary objectives of the trial
    - Disease Control Rate (DCR)
    - Incidence of adverse events (AEs), according to the National Cancer
    - Institute Common Toxicity Criteria (NCI-CTC) version 4.0
    - Progression free survival
    - Overall survival
    - tasso di controllo della malattia
    - incidenza di eventi avversi, secondo i criteri del National Cancer Institute Common Toxicity (NCI-CTC) versione 4.0
    - sopravvivenza libera da progressione
    - sopravvivenza globale
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Farmacogenomic: Version 1.0 - 18 March 2014
    Farmacogenomica: Versione 1.0 del 18 Marzo 2014
    E.3Principal inclusion criteria
    - Signed informed consent
    - Histologically or cytologically confirmed salivary glands cancer.
    - At least, one target lesion defined as RECIST 1.1 (clear progression of disease is required in the presence of one target lesion previously treated with radiotherapy
    - Clinical and/or radiological progression of disease on ADT
    - No limits are required for the number of previous chemotherapy lines
    - Age ≥18 years
    - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
    - Hemoglobin ≥ 9.0 g/dL independent of transfusion
    - Platelet count ≥ 100,000/μL
    - Serum albumin ≥ 3.0 g/dL
    - Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 mL/min
    - Serum potassium ≥3.5 mmol/L
    - Able to swallow the study drug whole as a tablet
    - Patients with treated brain metastases, stable within the last three months, are allowed
    Firma consenso informato
    - Età maggiore di 18 anni compiuti
    - Diagnosi di tumore delle ghiandole salivari istologicamente o citologicamente confermata
    - Almeno una lesione misurabile secondo criteri RECIST (è richiesta progressione di malattia evidente in caso di lesione target unica precedentemente trattata con radioterapia)
    - Progressione clinica o radiologica al blocco androgenico totale
    - ECOG Performance Status 0-1
    - Funzione midollare adeguata: neutrofili > 1.5 x 109/L, piastrine > 100 x 109/L, emoglobina > 9 g/dL
    - disponibilità di tessuto tumorale in sede tumore primitivo o recidiva
    - Disponibilità di prelievi ematici prima ed in corso di trattamento
    - Proseguimento della deprivazione androgenica con livelli di testosterone inferiori a 50 ng per decilitro (1.7 nmol per litro)
    - Non limitazione per il numero di linee chemioterapiche precedenti
    - Albumina sierica ≥ 3.0 g/dL
    - Creatinina sierica <1.5 x limite superiore di norma (ULN) e creatinina clearance calcolata > 60 mL/min
    - Potassio sierico ≥3.5 mmol/L
    - Possibilità di deglutire il farmaco come compressa intera.
    - Pazienti con metastasi encefaliche trattate, sono eleggibili se la malattia encefalica è stabile nei 3 mesi precedenti l’arruolamento
    - Se potenzialmente fertile, disponibiltà ad impiegare metodi contraccettivi (Pearl Index < 1; es. Contraccettivi (pillola), Spirale, impianto ormonale, patch transdermico, combinaizione di due metori di barrier (condom e diaframma) sterilizzazione, astinenza) per la durata dello studio e per le 13 settimane successive
    E.4Principal exclusion criteria
    - Received abiraterone acetate within the last 5 years
    - Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
    - Abnormal liver functions consisting of any of the following:
    Serum bilirubin ≥ 1.5 x ULN (except for subjects with documented Gilbert’s disease, for whom the upper limit of serum bilirubin is 3 mg/dL)
    Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 x ULN
    Patients with ALT and/or AST not exceeding 5X ULN due to liver mets can be enrolled
    - Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy.
    - Active or symptomatic viral hepatitis or chronic liver disease
    - History of pituitary or adrenal dysfunction
    - Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline
    - History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
    - Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of ≤1.
    - Subjects who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the investigator and for 13 weeks after last study drug administration
    - Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with other experimental drug
    - 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
    - Terapia con abiraterone acetato nei 5 anni precedenti
    - Malattie concomitanti serie o non controllate, incluse infezioni attive e non controllate
    - Funzione epatica anormale, secondo uno dei seguenti criteri:
    Bilirubina sierica ≥ 1.5 x ULN (eccetto che per i soggetti con Malattia di Gilbert documentata, per cui il limite superiore è 3 mg/dL)
    Aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) ≥ 2.5 x ULN
    Pazienti con ALT/AST che non eccedano 5X ULN per metastasi epatiche possono essere arruolati
    - Ipertensione non controllata (pressione sistolica ≥160 mmHg o pressione diastolica ≥95 mmHg); soggetti con storia di ipertensione controllata da terapia sono includibili
    - Malattia epatica cronica o epatite virale attiva o sintomatica
    - Storia di disfunzione surrenalica o pituitaria
    - 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
    - Storia di disordine gastrointestinale (disordine medico o chirurgia estensiva) che può interferire con l’assorbimento del farmaco in studio
    - Altre condizioni mediche concomitanti che possano inficiare la possibilità del paziente di partecipare allo studio
    - Qualsiasi tossicità acuta dovuta a chemioterapia o radioterapia precedente (NCI-CTC V 4.0) che non sia risolta o ≤1 di grado 1
    - Aver partecipato ad altri studi clinici o aver ricevuto qualsiasi farmaco all’interno di studio nei 30 giorni precedenti l’arruolamento
    -Pregresso 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.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the activity of abiraterone acetate plus prednisone in castration resistant SGCs
    Valutare l'attività di abiraterone acetato più prednisone nei tumori delle ghiandole salivari resistenti castrazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 years
    4 anni
    E.5.2Secondary end point(s)
    • Disease Control Rate (DCR)
    • Incidence of adverse events (AEs), according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
    • Progression free survival
    • Overall survival
    - tasso di controllo della malattia
    - incidenza di eventi avversi, secondo i criteri del National Cancer Institute Common Toxicity (NCI-CTC) versione 4.0
    - sopravvivenza libera da progressione
    - sopravvivenza globale
    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 Yes
    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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 ultimo soggetto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 18
    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 state24
    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 applicable
    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 Decision2014-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-26
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