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    Summary
    EudraCT Number:2012-001010-42
    Sponsor's Protocol Code Number:2012-001010-42
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-08-07
    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 number2012-001010-42
    A.3Full title of the trial
    A multicenter, prospective, randomized clinical trial for patients with relapsed osteosarcoma
    Studio clinico multicentrico, prospettico, randomizzato per il trattamento dei pazienti con osteosarcoma in recidiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study Protocol for patients with relapsed osteosarcoma
    Studio per il trattamento di pazienti con ricaduta di osteosarcoma
    A.3.2Name or abbreviated title of the trial where available
    ISG Os Rec
    ISG Os Rec
    A.4.1Sponsor's protocol code number2012-001010-42
    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 supportItalian Sarcoma Group
    B.4.2CountryItaly
    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 pointClinical Trial Office
    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.5.4Telephone number051 6366400
    B.5.5Fax number051 6366277
    B.5.6E-mailemanuela.marchesi@ior.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 ENDOXAN BAXTER*EV 1FL 1G
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SpA
    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 Powder 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.3.9.1CAS number 6055-19-2
    D.3.9.3Other descriptive nameCyclophosphamide
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(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 No
    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 ETOPOSIDE TEVA*FL 10ML 20MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA ITALIA 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 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 INNetoposide
    D.3.9.1CAS number 33419-42-0
    D.3.9.4EV Substance CodeL01CB01
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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.IMP: 3
    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 HOLOXAN*EV 1FL 1G
    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 Powder for solution for injection
    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 INNIFOSFAMIDE
    D.3.9.1CAS number 3778-73-2
    D.3.9.4EV Substance CodeSUB08125MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    High malignancy grade of osteosarcoma relapse
    recidiva di osteosarcoma ad alto grado di malignità
    E.1.1.1Medical condition in easily understood language
    relapsed osteosarcoma
    Ricaduta in pazienti affetti da osteosarcoma
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10031296
    E.1.2Term Osteosarcoma recurrent
    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
    To compare the efficacy and tollerability of two chemotherapeutic regimens (either Cyclophosphamide+ Etoposide or high dose Ifosfamide) currently used to treat relapsed Osteosarcoma patients
    confrontare l’efficacia/tollerabilità di due regimi chemioterapici (Ciclofosfamide ed Etoposide o Ifosfamide ad alte dosi) attualmente utilizzati nel trattamento delle recidive di Osteosarcoma
    E.2.2Secondary objectives of the trial
    To evaluate Clinical Benefit, Toxicity, Quality of life, Overall Survival, Progression Free Survival
    Valutare: Beneficio clinico,Tossicità,Qualità della vita,Overall Survival,Progression Free Survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.patients with high-grade malignant relapsed osteosarcoma 2.age at diagnosis <50 years 3.Lansky score o Karnofsky Performance status > 60% 4.First or subsequent relapse of osteosarcoma surgically unresectable or for whom surgery was oncologically not appropriate 5.Good organ function defined by: 1) serum creatinine < 2 times the upper limit for age, 2) total bilirubin <1.5 times the upper limit of age, 3) transaminases ≤ 2.5 times the upper limit for age, 4) alkaline phosphatase ≤ 5 times the upper limit for age (with the exclusion of patients with skeletal metastases) 6.Normal Heart function (VEF > 50%) 7.White blood cells >3 x 109/l and platelets >100 x 109/l 8.For female patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study 9.Written signed informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
    1.Diagnosi iniziale di recidiva di osteosarcoma ad alto grado di malignità 2.Età alla diagnosi di recidiva di osteosarcoma &lt;50 anni 3.Lansky score o Karnofsky Performance status &gt; 60% 4.Malattia in prima o ulteriore recidiva non resecabile chirurgicamente o per i quali l’intervento chirurgico viene giudicato oncologicamente non adeguato. 5.Buona funzionalità epatica e renale definita dai seguenti parametri: 1) creatinina serica &lt; 2 volte il limite superiore per età; 2) bilirubina totale &lt; 1.5 volte il limite superiore per età; 3) transaminasi ≤ 2.5 volte il limite superiore per età; 4) fosfatasi alcalina &lt; 5 volte il limite superiore per età (con l’esclusione dei pazienti con metastasi scheletriche). 6.Frazione di eiezione ventricolare &gt; 50%. 7.Globuli bianchi &gt;3 x 109/l e piastrine &gt;100 x 109/l. 8.I soggetti di sesso femminile che abbiano già avuto menarca, devono presentare un test di gravidanza negativo prima dell’inizio dello studio. 9.Sottoscrizione del modulo di consenso alla partecipazione allo studio da parte del soggetto interessato o da chi ne esercita la patria potestà.
    E.4Principal exclusion criteria
    1.Medical contraindications to the use of the drugs included in the Protocol. 2.Psychological conditions that don’t ensure either a good adhesion to the Protocol or a proper management of toxicity or a proper understanding of the study 3.Either HBV or HCV or HIV active infection 4.Previouly treatment with either Cyclophosphamide+ Etoposide or high dose Ifosfamide Pregnant or lactating patients
    1.Controindicazioni mediche all'uso dei farmaci previsti dal Protocollo. 2.Condizioni mentali o sociali che non garantiscano una adeguata adesione al protocollo, una corretta gestione domiciliare della tossicità, una adeguata comprensione della partecipazione allo studio. 3.Infezione da HBV, HCV e HIV in fase attiva. 4.Precedente trattamento con Ciclofosfamide-Etoposide oppure con Ifosfamide ad alte dosi. 5.Gravidanza o allattamento in atto al momento della diagnosi di recidiva.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the Overall Response Rate (ORR) defined as the percentage of patients with complete or partial response
    Determinare la Overall Response Rate (ORR), cioè la percentuale di pazienti che presentano una risposta completa o parziale
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 2 chemotherapy cycles
    dopo il 2° ciclo di chemioterapia
    E.5.2Secondary end point(s)
    Evaluate: Number of patients with complete response or stable disease >=4 months Number of patients with toxicity grade ≥3 (NCI CTAE version 4.0) Number of patients with death for any cause since the date of randomization to the date of last available follow-up Number of patients with relapse/progression/death for any cause since the date of randomization to the date of last available follow-up Quality of life evaluation by PedsQLTM and EORTC QLQ-C30 criteria
    Determinare:
    Proporzione di pazienti che presentano risposta completa o stabilizzazione di malattia per ≥ 4 mesi,
    Proporzione di pazienti che sviluppano tossicità di grado ≥3 secondo i criteri CTCAE versione 4.0 , Proporzione di pazienti che giungono al decesso per qualsiasi causa dalla data della randomizzazione alla data dell’ultimo follow-up disponibile, Proporzione di pazienti che presentano recidiva/progressione/decesso per qualsiasi causa dalla data della randomizzazione alla data dell’ultimo follow up disponibile, Valutazione della qualità della vita misurata con i criteri PedsQLTM (pz pediatrici) e EORTC QLQ-C30 (pz adulti)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After each cycle for toxicity,after 2 month for response and within 5 years for follow-up evaluations
    La tossicità viene rilevata ad ogni ciclo, la risposta viene valuata dopo 2 mesi, gli altri endpoints vengono valuati entro i 5 anni di follow-up
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned19
    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
    5 years after the last completed treatment
    5 anni dal completamento della terapia dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 Yes
    F.1.1Number of subjects for this age range: 70
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) No
    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 state104
    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 end of trial all the subjects will be follow-up by sites on the basis of the osteosarcoma ISG guidelines
    al termine dello studio i pazienti verranno seguiti presso i centri di riferimento, secondo le
    linee guida ISG per l'osteosarcoma
    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 Decision2012-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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