Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000473-23
    Sponsor's Protocol Code Number:RETRY
    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:2012-03-07
    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 number2012-000473-23
    A.3Full title of the trial
    PHASE II STUDY OF SUNITINIB AS RECHALLENGE THIRD-LINE THERAPY IN METASTATIC RENAL CANCER
    Studio di fase II con rechallenge di Sunitinib come trattamento di terza linea nel carcinma renale metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sunitinib rechallenge in metastatic kidney cancer
    Ritrattamento con Sunitinib nel carcinoma renale metastatico
    A.4.1Sponsor's protocol code numberRETRY
    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 SponsorGIOM - Gruppo Italiano Oncologia Nefrologica
    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 Policlinico San Matteo
    B.5.2Functional name of contact pointS.C. Oncologia medica
    B.5.3 Address:
    B.5.3.1Street AddressP.le Golgi 19
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number0382 502581
    B.5.5Fax number0382 525240
    B.5.6E-mailc.porta@smatteo.pv.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, hard
    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 INNSUNITINIB
    D.3.9.1CAS number 557795-19-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB22321
    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 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
    Metastatic renal cancer thrid-line therapy already treated in fist-line therapy with Sunitinib.
    Carcinoma renale metastatico in terza linea già trattato in prima linea con Sunitinib.
    E.1.1.1Medical condition in easily understood language
    Metastatic renal cancer already treated with Sunitinib.
    Carcinoma renale metastatico già trattato con Sunitinib.
    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 10009251
    E.1.2Term Clear cell carcinoma of the kidney
    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 assess the antitumor activity of Sunitinib in terms of freedom from disease progression.
    Determinare l’attività antitumorale di Sunitinib in termini di libertà da progressione di malattia.
    E.2.2Secondary objectives of the trial
    1)To evaluate Sunitinib activity in terms of objective response rate 2) To evaluate the efficacy in terms of progression free survival (PFS) and overall survival (OS) 3) To evaluate the tolerability of Sunitinib.
    1) Valutare l’attività di Sunitinib in termini di tasso di risposte obiettive 2) Valutare l’efficacia di Sunitinib in termini di progression free survival (PFS) ed overall survival (OS) 3) Valutare il profilo di tollerabilità di Sunitinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically proven diagnosis of Renal Cell Carcinoma with predominant clear cell component. 2. First-line treatment with Sunitinib. 3. Patients with a Disease Control Rate (Complete Response + Partial Response + Stable Disease) lasting at least 10 months from first-line Sunitinib treatment. 4. Second-line treatment with Everolimus. 5. Age higher than 18. 6. ECOG Performance Status 0-2. 7. Life expectancy of at least 8 weeks. 8. Measurable lesions according to RECIST criteria. 9. Adequate cardiac, hepatic, renal, and bone marrow function. 10. Written informed consent.
    1.Diagnosi istologica di carcinoma renale con predominanza a cellule chiare 2. Trattamento di prima linea con Sunitinib. 3. Pazienti con Disease Control Rate (Risposta completa + Risposta Parziale + Stabilità di Malattia) al trattamento di prima linea con Sunitinib perdurata almeno 10 mesi. 4. Trattamento di seconda linea con Everolimus; 5. Età magggiore di 18 anni. 6. ECOG Performance Status 0-2. 7. Aspettativa di vita di almeno 8 mesi. 8. Lesioni misurabili in accordo con i criteri RECIST. 9. Adeguata funzionalità renale, epatica, respiratoria, cardiaca e midollare. 10. Consenso informato scritto.
    E.4Principal exclusion criteria
    1. First-line treatment with other compounds (excluding Sunitinib). 2. Symptomatic and/or unstable and/or not previously treated pre-existing brain metastases. 3. Uncontrolled hypertension. 4. Severe or uncontrolled cardiovascular diseases within 6 months of study. 5. Active uncontrolled infections. 6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
    1. Trattamento di prima linea con altri farmaci (ad esclusione del Sunitinib). 2. Seconda linea di trattamento con farmaci diversi da Everolimus. 3. Metatstasi encefaliche sintomatiche e/o instabili e/o non precedentemente trattate. 4. Ipertensione arteriosa non controllata. 5. Malattie cardiovascolari severe o non controllate negli ultimi 6 mesi. 6. Stati settici in atto. 7. Altre neoplasie concomitanti o diagnosticate nei 5 anni precedenti ad eccezione di basaliomi o carcinomi in situ della cervice uterina.
    E.5 End points
    E.5.1Primary end point(s)
    Freedom from disease progression.
    Libertà da progressione di malattia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months.
    6 mesi.
    E.5.2Secondary end point(s)
    1) Objective response rate (CR + PR)
    2) PFS and OS
    3) Toxicity
    1) Tasso di risposte obiettive (CR + PR)
    2) PFS e OS
    3) Tossicità
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Non applicabile.
    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 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 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 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 years2
    E.8.9.1In the Member State concerned months0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state38
    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: the patient will receive sunitinib untill disease progression or unacceptable toxicity.
    Non applicabile: il paziente riceverà sunitinib fino a progressione di malattia o a tossicità inaccettabile
    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 Decision2012-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 02:57:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA