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    Summary
    EudraCT Number:2012-005428-14
    Sponsor's Protocol Code Number:ISG-STS-TRAB-2012
    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:2013-09-12
    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 number2012-005428-14
    A.3Full title of the trial
    A Phase II study on Trabectedin in advanced retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma
    Studio di fase II su trabectedina nei leiomiosarcomi e nei liposarcomi ben differenziati/dedifferenziati del retroperitoneo in fase avanzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the efficacy of Trabectedin in advanced retroperitoneal leiomyosarcoma and in liposarcoma
    Studio clinico per valutare l’efficacia della trabectedina nel leiomiosarcoma retroperitoneale avanzato e nel liposarcoma
    A.3.2Name or abbreviated title of the trial where available
    TRAVELL
    TRAVELL
    A.4.1Sponsor's protocol code numberISG-STS-TRAB-2012
    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 SponsorItalian Sarcoma Group
    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 supportPharma Mar S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto di Ricerche Farmacologiche "Mario Negri"
    B.5.2Functional name of contact pointLaboratory of Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressVia Giuseppe La Masa 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number00390239014642
    B.5.5Fax number00390233200231
    B.5.6E-mailluciano.carlucci@marionegri.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 Yondelis 1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/039
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 typeAntineoplastic medicinal
    D.IMP: 2
    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 Yondelis 0.25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/039
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 typeAntineplastic agent
    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
    Advanced retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma
    Leiomiosarcoma e liposarcoma ben differenziato/dedifferenziato del retroperitoneo in fase avanzata
    E.1.1.1Medical condition in easily understood language
    Tumours of muscle tissue (leiomyosarcoma) and tumours of fat tissue
    Tumori del tessuto muscolare (leiomiosarcoma) e tumori del tessuto grasso (liposarcoma)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10024627
    E.1.2Term Liposarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10073135
    E.1.2Term Dedifferentiated liposarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10024189
    E.1.2Term Leiomyosarcoma
    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
    Confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth.

    Confermare l’attività della trabectedina come seconda/ulteriore linea di trattamento nei leiomiosarcomi e nei liposarcomi ben differenziati/dedifferenziati del retroperitoneo.
    E.2.2Secondary objectives of the trial
    To investigate the peculiar benefit provided by trabectedin in typical retroperitoneal sarcomas, in order to help multidisciplinary clinical decision-making
    Un altro obiettivo di questo studio è quello di valutare il beneficio fornito dalla trabectedina nei sarcomi retroperitoneali, in modo da supportare il processo decisionale multidisciplinare nella gestione dei sarcomi in questa sede
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    "A Phase II study on Trabectedin in advanced retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma - biologic sub-study"

    Version 1.2, 14/04/2013

    Translational studies will be performed, with the aim of characterising the tumour biological features associated with different response patterns to trabectedin by miR determination in both neoplastic and plasma tissue in patients who will undergo surgery after trabectedin, comparing tumour tissue specimens collected before and after treatment
    Saranno effettuati studi a latere con lo scopo di definire le caratteristiche biologiche tumorali associate a differenti tipologie di risposta a trabectedina. Queste valutazioni saranno eseguite in tutti i Pazienti che si sottoporranno a chirurgia dopo il trattamento con trabectedina, attraverso l’analisi comparata di campioni di tessuto tumorale raccolti prima e dopo il trattamento con trabectedina
    E.3Principal inclusion criteria
    - Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated)
    - Pathology specimens available for centralized review
    - Age ≥ 18 years
    - ECOG PS ≤ 2
    - One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated)
    - Measurable disease, as defined by RECIST criteria
    - A minimum of 3 weeks since any previous medical therapy
    - Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower
    - Adequate haematological, renal and liver functions
    - Ability and willingness to provide informed consent
    - Persistenza di malattia o recidiva locale e/o malattia metastatica (in caso di malattia localizzata, la chirurgia può essere tecnicamente indicata o meno, ma il giudizio clinico deve indicare la necessità di una terapia medica)
    - Campioni di anatomia patologica disponibili per la revisione centralizzata
    - Età ≥ di 18 anni
    - ECOG PS ≤ 2
    - Uno o più trattamenti sistemici precedenti con antraciclina e ifosfamide (a meno che uno o entrambi non siano clinicamente controindicati)
    - Malattia misurabile, secondo i criteri RECIST
    - Un intervallo minimo di 3 settimane da qualsiasi terapia medica precedente
    - Assenza di eventi avversi in corso superiori al grado 1 (secondo il NCI CTC) provocati da trattamenti precedenti
    - Adeguata funzionalità ematica, renale ed epatica
    - Consenso informato firmato
    E.4Principal exclusion criteria
    - Pregnant or breast-feeding women
    - Prior exposure to trabectedin
    - Peripheral neuropathy, Grade 2 or higher
    - History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse
    - Known central nervous system (CNS) metastases
    - Active viral hepatitis or chronic liver disease
    - Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
    - Active major infection
    - Other serious concomitant illnesses
    - Donne in gravidanza o che allattano al seno
    - Precedente trattamento con trabectedina
    - Neuropatia periferica di Grado 2 o maggiore
    - Anamnesi di altre neoplasie (ad eccezione del basalioma o del carcinoma in situ della cervice, adeguatamente trattati), a meno che non siano in remissione da 5 anni o più e giudicate con scarso potenziale di recidiva
    - Metastasi a carico del sistema nervoso centrale
    - Epatite virale attiva o epatite cronica
    - Funzionalità cardiaca instabile, inclusa insufficienza cardiaca congestizia o angina pectoris, infarto miocardico avvenuto entro un anno dall’arruolamento nello studio, ipertensione arteriosa non controllata o aritmia
    - Gravi infezioni in atto
    - Altre patologie serie concomitanti
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of responders to trabectedin by means of Growth Modulation Rate, that is the ratio between PFS under trabectedin (PFS) and time to progression after previous chemotherapy treatment (TTP1). The primary end point will be calculated in the overall sample
    Proporzione delle risposte definite attraverso il Growth Modulation Rate, ovvero il rapporto tra la progressione libera da malattia (PFS) dopo trattamento con trabectedina e il tempo alla progressione (TTP1) dopo la prima/precedente linea di trattamento in ogni singolo Paziente
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 years
    6 anni
    E.5.2Secondary end point(s)
    - Objective response (OR) in the overall sample
    - Pathological tumour response in the two eligible histological types, in patients undergoing surgery after treatment
    - PFS and OR in the two eligible histological types
    - PFS in patients who undergo surgery after, or during, trabectedin treatment and those who do not
    - Safety profile
    - Efficacy of trabectedin in reducing cancer related pain
    - Risposta oggettiva (OR) nell’intero campione.
    - Risposta patologica del tumore nelle due tipologie istologiche eligibili, in Pazienti che sono sottoposti a chirurgia dopo il trattamento
    - PFS e OR nelle due tipologie istologiche eligibili
    - PFS in Pazienti che sono sottoposti a chirurgia dopo o durante la terapia medica e in quelli che non sono sottoposti a chirurgia
    - Profilo di sicurezza della trabectedina
    - Efficacia della trabectedina nel ridurre il dolore associato a tumore
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 years
    6 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 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 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.8.2.4Number 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 concerned21
    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 Yes
    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 arruolato (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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.1.1.1In 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state95
    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)
    None
    Nessuno
    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 Decision2013-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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