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    Summary
    EudraCT Number:2011-002632-99
    Sponsor's Protocol Code Number:ONC-NET-01
    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:2012-03-07
    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 number2011-002632-99
    A.3Full title of the trial
    SUTNET Trial: Biological and Clinical Phase II study of Sunitinib in patients with unresectable and/or metastatic pheochromocytoma/paraganglioma
    SUTNET Trial: Studio Clinico-Biologico Di Fase II Con Sunitinib In Pazienti Affetti Da Feocromocitomi/Paragangliomi In Stadio Avanzato e/o Non Resecabile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sunitinib in the treatment of metastatic Pheochromocytomas/Paragangliomas
    Sunitinib nel trattamento dei feocromocitomi/paragangliomi in fase avanzata non operabili
    A.3.2Name or abbreviated title of the trial where available
    SUTNET Trial
    SUTNET Trial
    A.4.1Sponsor's protocol code numberONC-NET-01
    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 SponsorISTITUTO NAZIONALE PER LA CURA 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 supportPfizer Italia Srl
    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 Tumori
    B.5.2Functional name of contact pointMilan ENETS Center of Excellence
    B.5.3 Address:
    B.5.3.1Street AddressVia G. Venezian, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number00390223902722
    B.5.5Fax number00390223902149
    B.5.6E-mailneuroendocrini@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 SUTENT*30CPS 50MG
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSUNITINIB MALATE
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 typeInibitore dell'attività della tirosin-chinasi nei recettori per i fattori VEGF, PDGF, KIT e FLT-3
    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
    Patients with unresectable and/or metastatic pheochromocytomas/paragangliomas
    Pazienti affetti da Feocromocitomi/Paragangliomi in stadio avanzato e/o non resecabile
    E.1.1.1Medical condition in easily understood language
    Patients with unresectable and/or metastatic pheochromocytoma/paraganglioma
    Pazienti affetti da Feocromocitomi/Paragangliomi in stadio avanzato e/o non operabile
    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 LLT
    E.1.2Classification code 10001375
    E.1.2Term Adrenal neoplasm NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Sunitinib in patients with metastatic pheochromocytomas/paragangliomas in terms of PFS
    Determinare il tasso di sopravvivenza a un anno in assenza di progressione (Progression-Free Survival, PFS)
    E.2.2Secondary objectives of the trial
    The overall survival (OS) and objective response (ORR) according to RECIST Criteria. To characterize the safety profile of Sunitinib To evaluate HIF-1 expression (optional study) To evaluate the effects of treatment with Sunitinib on circulating plasma levels of VEGF and their correlation with the response to treatment (optional study)
    Tasso di risposta oggettiva (Objective Response Rate, ORR): risposta parziale+risposta completa (PR+CR) confermata dal punto di vista radiologico secondo i criteri RECIST Sopravvivenza globale (Overall Survival, OS) Profilo di sicurezza e tollerabilità della terapia proposta. Studio opzionale Valutare l’espressione delle mutazioni somatiche e germinali dei geni SDHB (succinate dehydrogenase, subunit B) e VHL (Von Hippel Lindau), solitamente associati ad upregulation di HIF-1 e ad un downstream del segnale VEGF-relato, bersaglio terapeutico del sunitinib; con l’intento di individuare dei target biologici predittivi di risposta al trattamento in studio. Valutare i livelli circolanti di VEGF prima e durante il trattamento. Valutare la relazione tra i livelli circolanti di VEGF e la risposta al trattamento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title (Titolo, in inglese): Clinical and Biological Phase II study of Sunitinib in patients with unresectable and/or metastatic pheochromocytomas/paragangliomas
    Objectives (Obiettivi, in inglese): To evaluate HIF-1 expression. To evaluate the effects of treatment with sunitinib on circulationg plasma levels of VEGF and their correlation to treatment response.
    Titolo: Studio clinico-biologico di Fase II con Sunitinib in pazienti affetti da feocromocitomi/paragangliomi in stadio avanzato e/o non resecabile
    Obiettivi: Valutare l'espressione delle mutazioni somatiche e germinali dei geni SDHB e VHL, solitamente associati ad upregulation di HIF-1. Valutare i livelli circolanti di VEGF in relazione alla risposta al trattamento con Sunitinib.
    E.3Principal inclusion criteria
    Age >=18 years Patients with histological diagnosis of malignant pheochromocytoma or paraganglioma and either evidence of metastases or unresectability Measurable lesions according to RECIST criteria ECOG Performance Status 0-2 Life expectancy of at least 12 weeks Adequate cardiac, hepatic, renal, and bone marrow function
    Età &gt;= 18 anni. I soggetti devono avere conferma istologica di feocromocitoma/paraganglioma. Malattia tumorale parametrabile (in accordo ai criteri RECIST). Performance Status secondo ECOG 0-2. É ammesso l’arruolamento di pazienti che non hanno ricevuto nessun trattamento per la malattia avanzata o pazienti pretrattati con chirurgia, chemioterapia e terapia radiorecettoriale. Aspettativa di vita superiore a tre mesi.
    E.4Principal exclusion criteria
    Major surgical procedure within 28 days prior to study treatment start Evidence of current central nervous system (CNS) metastases or spinal cord compression. Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, meningiomas) Clinically significant cardiovascular disease.
    Interventi chirurgici effettuati entro 28 giorni prima dell’inizio del trattamento. Evidenza di metastasi a livello del SNC o di compressione midollare. Altre malattie neoplastiche diagnosticate nei precedenti 5 anni (ad eccezione dei basoteliomi cutanei, del carcinoma in situ della cervice uterina e dei meningiomi). Malattie cardiovascolari clinicamente significative
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy end point is one year progression free survival (PFS). To test a gain in PFS from 30%, representing insufficient treatment activity, to 50%, which is the therapeutic target, the Simon’s optimal two stage design requires the assessment of 22 patients at stage I and 46 patients at stage II. This according to a 10% Type I and Type II error probability levels.
    L’end point principale dello studio è rappresentato dall’assenza di progressione di malattia (progression free survival, PFS) ad un anno dall’inizio del trattamento. Per saggiare un incremento di PFS dal 30% (scarsa efficacia) al 50% (efficacia soddisfacente), il disegno a due stadi ottimale di Simon richiede una numerosità massima di 46 pazienti, avendo fissato al 10% le probabilità di errore di I e di II tipo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy end point is one year progression free survival (PFS).
    L’end point principale dello studio è rappresentato dall’assenza di progressione di malattia (progression free survival, PFS) ad un anno dall’inizio del trattamento.
    E.5.2Secondary end point(s)
    The overall survival (OS) and objective response rate (ORR) will be considered as secondary end points.
    La risposta obiettiva e la sopravvivenza globale (OS, tempo intercorrente tra l’inizio del trattamento e la morte per qualunque causa) saranno considerati come end points secondari.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study (48 months)
    Fine dello studio (dopo 48 mesi)
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Progression free survival
    Sopravvivenza libera da progressione PFS
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    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 months48
    E.8.9.1In the Member State concerned 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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state46
    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)
    At the end of the treatment period the patient will be followed according to standard clinical practice.
    Al termine della sperimentazione oggetto di studio il paziente verrà seguito in maniera routinaria secondo la normale pratica clinica prevista per la sua malattia.
    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 Decision2011-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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