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    Summary
    EudraCT Number:2013-001467-23
    Sponsor's Protocol Code Number:2013-001467-23
    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:2013-06-06
    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 number2013-001467-23
    A.3Full title of the trial
    SAFETY AND ACTIVITY OF TRABECTEDIN AS FIRST LINE IN ADVANCED SOFT TISSUE SARCOMA (STS) PATIENTS UNFIT TO RECEIVE STANDARD CHEMOTHERAPY: A PROSPECTIVE PHASE II STUDY WITH CLINICAL AND MOLECULAR CORRELATES
    (TR1US)
    Sicurezza e attività della trabectedina, come prima linea di trattamento nei pazienti affetti da sarcoma dei tessuti molli (STS) con malattia avanzata/non operabile non idonei a ricevere la chemioterapia standard con antraciclina e/o ifosfamide: studio prospettico di fase II con correlati clinici e molecolari
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy evaluation in soft tissue sarcoma unfit to received standard chemotherapy
    Valutazione dell’efficacia e della sicurezza in pazienti con sarcoma dei tessuti molli, non idonei a ricevere chemioterapia standard
    A.3.2Name or abbreviated title of the trial where available
    ISG_TR1US
    A.4.1Sponsor's protocol code number2013-001467-23
    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 supportPharmaMar
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationItalian Sarcoma Group
    B.5.2Functional name of contact pointPiero Picci
    B.5.3 Address:
    B.5.3.1Street AddressVia di Barbiano 1/10
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40136
    B.5.3.4CountryItaly
    B.5.6E-mailclinicaltrials@italiansarcomagroup.org
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPharmamar
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/039
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 or local advanced Soft tissue sarcoma, not amenable for standard chemotherapy regimen (doxorubicine/epirubicine and/or ifosfamide).
    Sarcoma dei tessuti molli metastatico o localmente avanzato non candidato al trattamento standard con doxorubicina/epirubicina e/o ifosfamide.
    E.1.1.1Medical condition in easily understood language
    Advanced sof tissue sarcoma not amenable for standard chemotherapy
    Sarcoma dei tessuti molli in fase avanzata per i quali non è possibile il trattamento con epirubicina/doxrubicina e/o ifosfamide
    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 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to assess the activity of trabectedin as a first line treatment in locally advanced/metastatic STS patients unfit to receive standard chemotherapy
    Valutazione dell’attività della trabectedina come trattamento di prima linea nei pazienti con STS localmente avanzato/metastatico non idonei a ricevere il trattamento standard.
    E.2.2Secondary objectives of the trial
    The secondary endpoints are:
    Tolerability and intolerable adverse reaction rate.
    Intolerable toxicity is defined as every AEs leading to treatment discontinuation or dose-reduction; furthermore, any AEs of at least grade 3 not resolved within 3 weeks of appropriate management should be regarded as an intolerable toxicity event. For haematological toxicity, given that the use of growth factors will be allowed, an intolerable toxicity is defined either as any grade 4 event, or a grade 3 event not resolved with adequate treatment. AEs will be graded according to NCI-CTCAE criteria v4.0 at the first cycle of therapy.
    - Objective response rate (ORR)
    - Progression free survival (PFS)
    - Overall survival (OS).
    *Valutazione della tossicità intollerabile e il tempo all’insorgenza di reazioni avverse.
    La tossicità intollerabile è definita come ogni evento avverso che porti alla sospensione del trattamento o alla riduzione della dose, inoltre l’insorgenza di eventuali eventi avversi di grado almeno pari a 3 che nonstante la corretta gestione degli stessi, non si risolvano entro 3 settimane sono considerati di tossicità intollerabile. Per la tossicità ematologica, dato che l'uso di fattori di crescita sarà consentito, la tossicità intollerabile è definita come qualsiasi evento di grado 4, o un evento di grado 3 non risolto con un trattamento adeguato. Gli eventi avversi saranno classificati secondo i criteri NCI-CTCAE v 4.0 al primo ciclo di terapia.
    * Probabilità di risposta obiettiva (ORR)
    * Sopravvivenza libera da progressione (PFS)
    * Sopravvivenza globale (OS).

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational study related to the first line trabectedine treatment in peatient unfit to receive standard chemotherapy
    Studio transazionale relativo al trattamento con trabectedina in prima linea nel sarcoma dei tessuti molli in pazienti non idonei a ricevere chemioterapia standard
    E.3Principal inclusion criteria
    * Adult patients (≥18 years), who, in the judgment of the clinician, is deemed not suitable to receive an anthracycline and/or ifosfamide based chemotherapy;
    * Pathological diagnosis of STS;
    *Inoperable, locally advanced or metastatic tumor;
    *Unsuited to receive doxorubicine and ifosfamide: ie stable arrhythmia, previous myocardial infarction; age≥80 years
    *Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
    *Glomerular filtration rate (GFR) ≥30 mL per min
    *Adequate hematologic function: Hemoglobin ≥9 g/dL; Absolute neutrophil count (ANC) ≥1,500/μL, and Platelet count ≥100,000/μL
    *Creatinine phosphokinase (CPK) < 2.5 ULN
    *Adequate hepatic function: total bilirubin < ULN, total alkaline phosphatase < 2.5 ULN, or if > 2.5 ULN consider alkaline phosphatase liver fraction or GGT or 5’ nucleotidase must be < ULN, AST and ALT <2.5 x ULN, Albumin > 20 g/L.
    *Patient´s written informed consent
    •Pazienti adulti (≥ 18 anni), che, a giudizio clinico, non sono idonei a ricevere chemioterapia con antracicline e/o ifosfamide
    •Diagnosi patologica di STS;
    •Tumore inoperabile metastatico e/o localmente avnzato;
    •Soggetti non idonei a ricevere doxorubicina e ifosfamide per aritmia stabile, precedente infarto miocardico, età ≥ 80 anni
    •Performance Status secondo ECOG (Eastern Cooperative Oncology Group) 0-2
    •Velocità di filtrazione glomerulare (GFR) ≥ 30 mL per min
    •Adeguata funzionalità ematologica: emoglobina ≥ 9 g / dl; conta assoluta dei neutrofili (ANC) ≥ 1.500 / mL, piastrine ≥ 100.000 / mL
    •Creatinina fosfochinasi (CPK) <2,5 ULN
    •Adeguata funzionalità epatica: bilirubina totale <ULN, fosfatasi alcalina <2,5 ULN, o se> 2,5 ULN considerare frazione alcalina fosfatasi epatica o GGT o 5 'nucleotidasi deve essere <ULN, AST e ALT <2,5 x ULN, albumina> 20 g / L.
    •Consenso informato scritto fornito dal paziente
    E.4Principal exclusion criteria
    * Prior exposure to Trabectedin.
    * PS≥2
    * Prior treatment with anthracyclines and or ifosfamide.
    * History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 or more years and judged of negligible potential of relapse.
    * Active viral hepatitis or chronic liver diseases, which in the judgement of the primary investigator represents a clinical contraindication to the therapy.
    * Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 6 months before enrolment, uncontrolled arterial hypertension or arrhythmias, LVEF<40%
    * Active major infection.
    * Other serious concomitant illnesses.
    *Pregnant subjects or breast feeding, or planning to become pregnant within 6 months after the end of treatment All sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment and must agree to use highly effective contraception during treatment and for 6 months after the end of treatment.
    •Precedente esposizione a Trabectedina.
    •Precedente trattamento con antracicline e/o ifosfamide.
    •Storia di altre neoplasie maligne (eccetto il carcinoma delle cellule basali o carcinoma cervicale in situ, adeguatamente trattati), a meno che in remissione per 5 o più anni e giudicati non recidivabili.
    •Presenza di epatite virale attiva o con patologie epatiche croniche, che, a giudizio dello sperimentatore principale rappresenta una controindicazione clinica alla terapia.
    •Condizione di instabilità cardiaca, inclusa insufficienza cardiaca congestizia o angina pectoris, infarto al miocardico entro 6 mesi prima dell'arruolamento, ipertensione arteriosa non controllata o aritmie, FEVS <40%
    • Presenza di infezione attiva maggiore.
    •Altre gravi malattie concomitanti.
    •Soggetti in stato di gravidanza o allattamento, o che stanno pianificando una gravidanza entro 6 mesi dalla fine del trattamento. Tutti i pazienti sessualmente attivi di sesso femminile in età fertile devono avere un test di gravidanza negativo (siero o urine) entro i 7 giorni precedenti l'arruolamento e devono accettare di utilizzare un contraccettivo altamente efficace durante il trattamento e per 6 mesi dopo la fine del trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of this trial is the Progression Free Survival Rate at 3 months (PFS3). Non progression is defined as CR, PR or SD according to RECIST v.1.1 criteria.
    Probabilità di sopravvivenza libera da progressione a 3 mesi (PFS3)
    La progressione è definita come CR, PR o SD secondo i criteri RECIST v.1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months from the start therapy
    a 3 Mesi dall’inizio della terapia
    E.5.2Secondary end point(s)
    Tolerability and intolerable adverse reaction rate.
    Intolerable toxicity is defined as every AEs leading to treatment discontinuation or dose-reduction; furthermore, any AEs of at least grade 3 not resolved within 3 weeks of appropriate management should be regarded as an intolerable toxicity event. For haematological toxicity, given that the use of growth factors will be allowed, an intolerable toxicity is defined either as any grade 4 event, or a grade 3 event not resolved with adequate treatment. AEs will be graded according to NCI-CTCAE criteria v4.0 at the first cycle of therapy.
    - Objective response rate (ORR)
    - Progression free survival (PFS)
    - Overall survival (OS).
    *Valutazione della tossicità intollerabile e il tempo all’insorgenza di reazioni avverse.
    La tossicità intollerabile è definita come ogni evento avverso che porti alla sospensione del trattamento o alla riduzione della dose, inoltre l’insorgenza di eventuali eventi avversi di grado almeno pari a 3 che nonstante la corretta gestione degli stessi, non si risolvano entro 3 settimane sono considerati di tossicità intollerabile. Per la tossicità ematologica, dato che l'uso di fattori di crescita sarà consentito, la tossicità intollerabile è definita come qualsiasi evento di grado 4, o un evento di grado 3 non risolto con un trattamento adeguato. Gli eventi avversi saranno classificati secondo i criteri NCI-CTCAE v 4.0 al primo ciclo di terapia.
    * Probabilità di risposta obiettiva (ORR)
    * Sopravvivenza libera da progressione (PFS)
    * Sopravvivenza globale (OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Tolerability and intolerable adverse reaction rate: during all the study
    For Objective Response Rate (ORR): form study entry up to the end
    For Progression-free survival (PFS): after 6/7 weeks from the start of therapy and then every 9 weeks
    For Overall survival (OS): from studt entry up to death
    Tasso di reazioni avverse tollerabili ed intollerabili: per tutto il corso della terapia
    Sopravvivenza libera da progressione (PFS): dopo 6/7 settimane dall’inizio terapia e successivamente ogni 9 settimane
    Sopravvivenza globale (OS): a partire dall’ingresso in studio sino al decesso
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.8.3 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.8.5The 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 years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    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)
    All the patients will be treated, at the end of study, with the standard of care planned for their pathology and with the best available option for support care
    I pazienti al termine dello studio saranno seguiti con lo standard of care previsto per la loro patologia
    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 Decision2013-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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