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   43858   clinical trials with a EudraCT protocol, of which   7284   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:2011-006205-95
    Sponsor's Protocol Code Number:2011-006205-95
    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:2012-08-09
    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 number2011-006205-95
    A.3Full title of the trial
    Toremifene in desmoid tumor: prospective clinical trial and identification of potential molecular targets
    Toremifene nel tumore desmoide: studio clinico prospettico e identificazione di potenziali target molecolari
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy of toremifene in desmoid tumor and identification of potential targets
    Valutazione di efficacia del toremifene nel tumore desmoide e identificazione di potenziali bersagli
    A.3.2Name or abbreviated title of the trial where available
    Toremifene in desmoid tumor
    Toremifene nel tumore desmoide
    A.4.1Sponsor's protocol code number2011-006205-95
    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 supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO NAZIONALE PER LA CURA DEI TUMORI
    B.5.2Functional name of contact point-
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number02-23903714
    B.5.5Fax number02-23902404
    B.5.6E-mailchirurgia.sarcomi@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 FARESTON*30CPR 60MG
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH 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 IMPGastric use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOREMIFENE CITRATE
    D.3.9.1CAS number 89778-27-8
    D.3.9.4EV Substance CodeSUB04923MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 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 typeAntiestrogeno
    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
    Primary or recurrent sporadic desmoid tumor
    Tumore desmoide sporadico primitivo o recidivo
    E.1.1.1Medical condition in easily understood language
    Desmoid tumor never treated or recurrent after being previously treated
    Tumore desmoide non FAP-correlato mai trattato e che si è ripresentato dopo trattamento
    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 SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the efficacy of toremifene in terms of tumor response rate and symptom relief in patients with desmoid tumors
    Determinare l’efficacia di toremifene in termini di risposta tumorale e beneficio sintomatico in pazienti con tumore desmoide
    E.2.2Secondary objectives of the trial
    -Determine the safety of toremifene in patients with sporadic primary or recurrent desmoid tumor -Determine the quality of life of patients treated with toremifene -Identify a correlation between specific marker expression and response to treatment
    -Determinare la sicurezza di toremifene in pazienti con tumore desmoide sporadico primitivo o recidivo-Determinare la qualita’ di vita dei pazienti trattati con toremifene-Identificare una correlazione tra l’espressione di specifici markers e la risposta al trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (age > 18 years) with primary or locally recurrent, sporadic or FAP associated, desmoid fibromatosis. - Histologically documented diagnosis of DF. - At least one measurable site of disease at CT or MRI scans, which has not been previously embolised or irradiated. - Progressive disease demonstrated at contrast-enhanced MRI or CT scan by Response Evaluation Criteria in Solid Tumors (RECIST). - Radiologic or clinical evidence of PD in the previous 6 months. Radiologic PD will be defined according to RECIST. - ECOG Performance status: 0-2. - Prior hormonal therapy, chemotherapy, or molecular targeted therapies are allowed - Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L. - Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. - Life expectancy of at least 6 months. - Written, voluntary, informed consent.
    - Adult patients (age &gt; 18 years) with primary or locally recurrent, sporadic or FAP associated, desmoid fibromatosis. - Histologically documented diagnosis of DF. - At least one measurable site of disease at CT or MRI scans, which has not been previously embolised or irradiated. - Progressive disease demonstrated at contrast-enhanced MRI or CT scan by Response Evaluation Criteria in Solid Tumors (RECIST). - Radiologic or clinical evidence of PD in the previous 6 months. Radiologic PD will be defined according to RECIST. - ECOG Performance status: 0-2. - Prior hormonal therapy, chemotherapy, or molecular targeted therapies are allowed - Adequate end organ function, defined as the following: total bilirubin &lt; 1.5 x ULN, SGOT and SGPT &lt; 2.5 x UNL (or &lt; 5 x ULN if hepatic metastases are present), creatinine &lt; 1.5 x ULN, ANC &gt; 1.5 x 109/L, platelets &gt; 100 x 109/L. - Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. - Life expectancy of at least 6 months. - Written, voluntary, informed consent.
    E.4Principal exclusion criteria
    - Previous history of deep vein thrombosis. - Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/√RR) or history of familial long QT syndrome. - Previous arrhythmia. - Clinically significant bradycardia. - Endometrial hyperplasia. - Hepatic insufficiency. - Other concurrent hormonal therapy, including hormonal contraceptives. - Patient has received any other investigational agents within 28 days of first day of study drug dosing. - Female patients who are pregnant or breast-feeding. - Patient has a severe and/or uncontrolled medical disease. - Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. - Patient received chemotherapy within 4 weeks prior to study entry. - Patient had a major surgery within 2 weeks prior to study entry.
    - Previous history of deep vein thrombosis. - Evidence of prolonged QTc &gt;480 msec (using Bazetts correction, for which the formula is: QTc = QT/√RR) or history of familial long QT syndrome. - Previous arrhythmia. - Clinically significant bradycardia. - Endometrial hyperplasia. - Hepatic insufficiency. - Other concurrent hormonal therapy, including hormonal contraceptives. - Patient has received any other investigational agents within 28 days of first day of study drug dosing. - Female patients who are pregnant or breast-feeding. - Patient has a severe and/or uncontrolled medical disease. - Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. - Patient received chemotherapy within 4 weeks prior to study entry. - Patient had a major surgery within 2 weeks prior to study entry.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) computed for each patient, from the date of toremifene onset to the date of progression or interruption for any cause or to the date of last observation if progression free assessed according to RECIST criteria -Time to pain relief from the date of toremifene onset to the date of pain relief according to visual analog scale (VAS)
    -Sopravvivenza libera da progressione (PFS) calcolata per ogni paziente dalla data dell`inizio del toremifene alla data della progressione o interruzione per qualasiasi causa o alla data dell`ultima osservazione se libera da progressione secondo i criteri di RECIST -Tempo al miglioramento del dolore dalla data dell`inizio del toremifene alla data del miglioramento del dolore in accordo con la la scala analogica visuale (VAS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be evaluated at 3 months
    Sopravvivenza libera da malattia valutata a 3 mesi
    E.5.2Secondary end point(s)
    -Descriptive evaluation of any adverse events registered from the date of toremifene onset according to the Common Toxicity Criteria for Adverse Events (NCI - CTC) version 4.03 -Descriptive evaluation of quality of life using QLQ-C30 EORTC Questionnaire -Correlation between expression pattern of specific marker/target and response to toremifene treatment
    -Valutazione descrittiva di ogni evento avverso registrato dalla data dell'inizio del toremifene secondo i criteri CTAE versione 4.03 -Valutazione descrittiva della qualità di vita usando il questionario QLQ-C30 EORTC -Correlazione tra espressione di specifici marker/target e risposta al trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Adverse events registered during the entire duration of the study -Quality of life: at the accrual and at the progression or end of the study -Correlation between markers expression and response at the end
    -Eventi avversi vengono registrati durante tutto lo studio -Qualità della vita ad inizio e a progressione o termine dello studio -Correlazione tra risposta e markers al termine
    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 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 years3
    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: 28
    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 state30
    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)
    Patients will be followed at the end of the of the study every 3 months for the first two years and then two times per year until the fifth year, then annually until the tenth year.
    I pazienti verranno poi seguiti al termine dello studio ogni 3 mesi per i primi due anni dall'inizio del trattamento e ogni sei fino al 5° anno, dopodichè annualmente fino al 10° anno.
    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 Decision2012-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Wed Apr 24 11:47:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA