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    Summary
    EudraCT Number:2006-004437-15
    Sponsor's Protocol Code Number:ONC-2006-002
    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:2006-12-13
    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 number2006-004437-15
    A.3Full title of the trial
    FASE II PROSPECTIVE STUDY BAY-43-90006 IN ADVANCED, METASTATIC SOFT TISSUE SARCOMAS, AFTER ANTRACYCLINE-BASED THERAPY
    FASE II PROSPECTIVE STUDY BAY-43-90006 IN ADVANCED, METASTATIC SOFT TISSUE SARCOMAS, AFTER ANTRACYCLINE-BASED THERAPY
    A.3.2Name or abbreviated title of the trial where available
    ONC-2006-002
    ONC-2006-002
    A.4.1Sponsor's protocol code numberONC-2006-002
    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 CLINICO HUMANITAS
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 SORAFENIB
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HEALTHCARE AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Tablet
    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 INNSORAFENIB
    D.3.9.2Current sponsor codeBay 43-9006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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 typeNon Applicabile
    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
    Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line antracycline-based regimen
    sarcoma dei tessuti molli metastatico o ricaduto dopo trattamento chemioterapico con antracicline
    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 HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    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
    Overall response rate (proportion of patients with confirmed partial and complete responses).Overall response rate (proportion of patients with confirmed partial and complete responses).
    determinare il tasso di risposta globale (remissioni parziali + complete).
    E.2.2Secondary objectives of the trial
    • Time to progression (TTP) • Overall disease control rate (Proportion of patients who have a best response rating of complete response [CR], PR or SD according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, that is maintained for at least 28 days from the first demonstration of that rating) • Overall duration of response. • Overall survival (OS) EMEND.2 Immunohistochemical analysis (IHC) of expression of PDGF-R alpha and beta on paraffin-embedded tissue
    determinare il tempo alla progressione,il tasso di controllo della malattia,la durata della risposta e la sopravvivenza globale (OS) EMEND.2 analisi immunoistochimica dell`espressione di PDGF-R alfa e beta nel tessuto
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI:
    valutazione eventuale espressione del recettore del PDGF (plateled-derived growth factor receptor alfa e beta) sul tessuto tumorale.

    E.3Principal inclusion criteria
    • Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line antracycline-based regimen; • At least one unidimensional target lesion (RECIST criteria); • Age &#8805; 18 years; • Eastern Cooperative Oncology Group (ECOG) performance status &#61603; 2; • Life expectancy &#8805; 12 weeks; • The following laboratory parameters: • Absolute neutrophyl count (ANC) > 1,5 x 109/L • Platelet Count > 100X 109/L • Serum Creatinine < 1,5 x the upper limit of normal • Serum bilirubin < 1,5 mg/dL • Alkaline phosphatase, alanine transaminase (ALT) and aspartate transaminase(AST) < 2,5 x the upper limit of normal; in case of hepatic metastases < 5 x the upper limit of normal.
    diagnosi istologica di sarcoma dei tessuti molli metastatico o ricaduto dopo trattamento chemioterapico con antracicline; malattia misurabile per almeno 1 dimensione (criteri RECIST); eta' &gt;18 anni; PS (ECOG) &#61603; 2; aspettativa di vita &#61619; 3 mesi; adeguata riserva midollare, funzionalita' epatica e renale; consenso informato scritto.
    E.4Principal exclusion criteria
    • Major surgery within 4 weeks of study entry; radiotherapy within 3 weeks of study entry; • Previous or concurrent cancer that is distinct in primary site or histology from STS, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted; • Renal failure requiring hemo- or peritoneal dialysis; • History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted; • Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0); • Known history of human immunodeficiency virus (HIV) infection; • Known Central Nervous System tumors including metastatic brain disease; • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry; • History of organ allograft; • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results; • Known or suspected allergy to the investigational agent or any agent given in association with this trial; • Patients unable to swallow oral medications. • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth.
    aritmia cardiaca (richiedente l'uso di antiaritmici); insufficienza cardiaca congestizia (&gt; New York Heart Association (NYHA) classe 2); ischemia cardiaca o coronaropatia attiva; chirurgia &lt; 4 settimane dall'ingresso nello studio; radioterapia &lt; 3 settimane dall'ingresso nello studio; allotrapianto in anamnesi; diagnosi di sanguinamento gastrico &lt; 30 gg dall'ingresso nello studio; gravidanza o allattamento; malattie concomitanti serie o infezioni non controllate; segni clinici di metastasi cerebrali e/o meningee.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate is defined as the proportion of patients with the best tumor response (confirmed partial or complete response) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria.
    Tasso di risposta globale (ORR): proporzione di pazienti che hanno ottenuto la migliore risposta (risposta parziale o completa) durante il trattamento o entro 30 giorni dal termine del trattamento confermata secondo i criteri di risposta RECIST.
    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 No
    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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    STUDIO PROSPETTICO
    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 concerned4
    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 Information not present in EudraCT
    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
    SE VERRa' OSSERVATO UN NUMERO DI RISPOSTE MINORE O UGUALE A 2 LO STUDIO VERRa' INTERROTTO PREMATURAMENTE
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-12-13. Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pazienti affetti da sarcoma dei tessuti molli in fase localmente avanzata o metastatica dopo chemiot
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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 Decision2006-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
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