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    Summary
    EudraCT Number:2020-005626-29
    Sponsor's Protocol Code Number:IRFMN-SARCO-7953
    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:2021-06-07
    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 number2020-005626-29
    A.3Full title of the trial
    A phase II study on trabectedin in combination with PPARg agonist pioglitazone in patients with round cell myxoid liposarcomas or dedifferentiated G1 and G2 liposarcomas with stable disease after a monotherapy with trabectedin.
    Studio clinico di fase II in pazienti con liposarcoma mixoide/ a cellule rotonde o liposarcoma dedifferenziato G1 e G2 con malattia stabile e in trattamento con trabectedina con l’obiettivo di valutare l’associazione di trabectedina e il farmaco PPARg agonista pioglitazone.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE II CLINICAL STUDY, ON TRABECTEDIN IN COMBINATION WITH PPARg AGONIST PIOGLITAZONE IN PATIENTS WITH ROUND CELL MYXOID LIPOSARCOMAS OR DEDIFFERENTIATED G1 OR G2 LIPOSARCOMAS WITH STABLE DISEASE IN TREATMENT WITH TRABECTEDIN ALONE.
    STUDIO CLINICO DI FASE II, VOLTO A VALUTARE L'ASSOCIAZIONE DEL FARMACO TRABECTEDINA E DEL FARMACO PIOGLITAZONE PPARPg AGONISTA, IN PAZIENTI CON LIPOSARCOMA DI TIPO MIXOIDE/ A CELLULE ROTONDE O LIPOSARCOMA DEDIFFERENZIATO G1 E G2, CON MALATTIA STABILE E IN TRATTAMENTO CON IL FARMACO TRABECTEDINA.
    A.3.2Name or abbreviated title of the trial where available
    TRABEPIO
    TRABEPIO
    A.4.1Sponsor's protocol code numberIRFMN-SARCO-7953
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    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 (bandi per la ricerca indipendente)
    B.4.2CountryItaly
    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 pointLaboratorio di Metodologia per la R
    B.5.3 Address:
    B.5.3.1Street AddressVIA MARIO NEGRI, 2
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014681
    B.5.5Fax number0233200231
    B.5.6E-mailtrabepio@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 Pioglitazone
    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.3.1Product namePioglitazone
    D.3.2Product code [Pioglitazone]
    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 INNPIOGLITAZONE
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 typeIpoglicemizzante
    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
    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.3.1Product nameTrabectedina
    D.3.2Product code [Trabectedina]
    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 INNTRABECTEDINA
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameTRABECTEDIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typenot less then
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 typeagente anti-neoplastico
    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 myxoid/round cell liposarcoma treated with at least 4 cycle of T alone with a stable disease at the last tumor evaluation
    Pazienti con diagnosi di liposarcoma mixoide/a cellule rotonde trattati per almeno 4 cicli con trabectedina da sola e con malattia stabile in base all’ultima valutazione di malattia.
    E.1.1.1Medical condition in easily understood language
    Patients who have been diagnosed with round cell myxoid liposarcoma and who have been treated with only trabectedin and who according to the latest assessment have stable disease.
    Pazienti con diagnosi di liposarcoma di tipo mixoide/ a cellule rotonde che sono stati trattati negli ultimi 4 cicli con solo il farmaco trabectedina e con malattia stabile all'ultima valutazione.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10024628
    E.1.2Term Liposarcomas malignant
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10073139
    E.1.2Term Round cell 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10073137
    E.1.2Term Myxoid liposarcoma
    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
    This study is aimed at assessing the activity of T in combination with P in patients diagnosed with round cell myxoid liposarcomas or dedifferentiated G1 and G2 liposarcomas with stable disease after 4 cycles of treatment with T administered in monotherapy.
    Lo studio è finalizzato a valutare l'attività di Trabectedina (T) in combinazione con Pioglitazione (P) in pazienti con diagnosi di liposarcoma mixoide a cellule rotonde o liposarcomi dedifferenziati G1 e G2 con malattia stabile (SD) dopo almeno 4 cicli di trattamento con T somministrata in monoterapia.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be to describe the efficacy and the safety of the combination treatment with T and P.
    Descrivere l'efficacia e la sicurezza di trabectedina in combinazione con pioglitazone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of myxoid/round cell liposarcomas
    2. Histological diagnosis confirmation by a reference centre
    3. Age = 18 years
    4. ECOG PS =2
    5. One or more previous systemic treatments employing anthracyclines +/- ifosfamide (unless one or both are clinically contraindicated)
    6. Four or more previous cycles of T with a stable disease as defined by RECIST criteria
    7. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or higher
    8. Provision of signed informed consent
    1. Diagnosi di liposarcoma mixoide/a cellule rotonde
    2. Diagnosi di malattia confermata da un centro di riferimento per il trattamento dei sarcomi
    3. Età pari o superiore a 18 anni
    4. ECOG Performance Status inferiore o pari a 2
    5. Almeno un trattamento sistemico precedente a base di antracicline +/- ifosfamide (a meno che uno o entrambi non siano clinicamente controindicati)
    6. Stabilità di malattia (SD) dopo almeno quattro cicli precedenti di terapia sistemica a base di T , in accordo ai criteri RECIST 1.1
    7. Risoluzione di eventuali eventi avversi correlati a terapie precedenti di grado 1 o superiore secondo la classificazione NCI CTC
    8. Consenso informato scritto
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding women
    2. Partial response or progression disease as per RECIST criteria to the previous treatment with T
    3. Inadequate haematological, renal and liver functions
    4. History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged
    of negligible potential of relapse
    5. Known central nervous system (CNS) metastases
    6. Active viral hepatitis or chronic liver disease
    7. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial
    hypertension or arrhythmias
    8. Active major infection
    1. Donne in stato di gravidanza o allattamento
    2. Risposta parziale o malattia in progressione al trattamento precedente con T secondo i criteri RECIST
    3. Funzionalità ematologica, renale o epatica inadeguate
    4. Storia di altre neoplasie maligne (ad eccezione del carcinoma basocellulare o del cancro cervicale in situ, adeguatamente trattati), a meno che in remissione da almeno 5 anni o giudicate come recidive potenzialmente trascurabili
    5. Presenza di metastasi note a carico del sistema nervoso centrale (SNC)
    6. Epatite virale attiva o malattia epatica cronica
    7. Condizione cardiaca instabile, tra cui insufficienza cardiaca congestizia o angina pectoris, infarto del miocardio, entro un anno prima dell’arruolamento, ipertensione arteriosa incontrollata o aritmie
    8. Grave infezione attiva
    E.5 End points
    E.5.1Primary end point(s)
    Objective response (OR) according to RECIST criteria or CHOI criteria
    Risposta oggettiva (OR) in accordo ai criteri RECIST o CHOI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The objective response (CR or PR) according to RECIST v. 1.1 or CHOI criteria will be evaluated during the treatment until disease progression, consent withdrawal, lost to follow-up, death.
    La risposta oggettiva (CR o PR), sarà valutata durante il trattamento in accordo ai criteri CHOI e RECIST v. 1.1 fino a progressione, ritiro del consenso, perdita al follow-up, morte.
    E.5.2Secondary end point(s)
    1. Number and severity of Adverse Events according to NCI CTC v.5.0
    2. Pharmacokinetics parameters
    1. Numero e severità di eventi avversi in accordo con NCI CTC v.5.0
    2. Parametri di farmacocinetica
    E.5.2.1Timepoint(s) of evaluation of this end point
    The detection time will be calculated for the patients who will not experience serious adverse events and who maintain stable pharmacokinetic parameters during the study.
    Il tempo di rilevazione verrà calcolato in tutti i pazienti che non sperimenteranno gravi eventi avversi e che mantengano i parametri di farmacocinetica stabili durante l'intero studio.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 pilota monocentrico e a braccio singolo
    Single institution, single arm, pilot study
    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 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 Information not present in EudraCT
    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
    If no response, about the 10 patients enrolled in the study, will be observed, the study will be stopped, on the contrary when the first enrolled patient is observed in response and after at least 4 patients evaluated with pharmacokinetic parameters, the pilot phase of the study will be interrupted and the second randomized phase can begin.
    se non si osserverà alcun paziente in risposta, sui 10 pazienti arruolati, lo studio verrà interrotto al contrario quando sarà osservato il primo paziente in risposta e dopo almeno 4 pazienti con parametri farmacocinetici valutati, la fase pilota dello studio verrà interrotta e potrà iniziare la seconda fase randomizzata.
    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 months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial 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: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 conclusion of treatment, the doctor will ask to patients to repeat some necessary examinations to assess the state of the disease and health conditions. In addition, the patients will be made some periodic visits after the end of the treatment. These visits will be made on a scheduled basis (every 3 months for a year) to evaluate the patient's health after treatment.
    Dopo la conclusione del trattamento il medico responsabile chiederà di ripetere alcuni esami necessari per valutare lo stato della malattia e le condizioni di salute. Inoltre verranno effettuate alcune visite periodiche successive alla fine del trattamento. Queste visite (chiamate di follow-up) saranno effettuate con cadenza programmata (ogni 3 mesi circa per un anno) e hanno lo scopo di valutare la salute del paziente dopo il trattamento.
    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 Decision2021-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-09-23
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