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    EudraCT Number:2014-002446-47
    Sponsor's Protocol Code Number:1320-BTG
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-14
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-002446-47
    A.3Full title of the trial
    Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group.
    Trabectedina en el meningioma de grado II o III recurrente: un estudio aleatorizado de fase II del Grupo de Tumores Cerebrales de la EORTC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group.
    Trabectedina en el meningioma de grado II o III recurrente: un estudio aleatorizado de fase II del Grupo de Tumores Cerebrales de la EORTC
    A.4.1Sponsor's protocol code number1320-BTG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02234050
    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 SponsorEuropean Organization for Research and Treatment of Cancer (EORTC)
    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 supportEORTC
    B.4.1Name of organisation providing supportPharma Mar, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organization for Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointClinical operations department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.4Telephone number003227741072/
    B.5.5Fax number003227741030/
    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. name Yondelis 1 mg powder for concentrate for solution for infusion
    D. of the Marketing Authorisation holderPharma Mar, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Recurrent high-grade meningioma
    Meningioma de alto grado recidivante
    E.1.1.1Medical condition in easily understood language
    Recurrent high-grade meningioma
    Recurrent high-grade meningioma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10027191
    E.1.2Term Meningioma
    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
    The aim of this randomized phase II study is to collect data on activity, safety and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.
    El objetivo del estudio aleatorizado de fase II es recopilar datos relacionados con la actividad, la toxicidad y la calidad de vida del tratamiento con trabectedina en pacientes con meningioma de alto grado recidivante.
    E.2.2Secondary objectives of the trial
    The aim of this randomized phase II study is to collect data on activity, safety and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma and to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after resection and radiotherapy.
    El objetivo del estudio aleatorizado de fase II es recopilar datos relacionados con la actividad, la toxicidad y la calidad de vida del tratamiento con trabectedina en pacientes con meningioma de alto grado recidivante e investigar si la trabectedina demuestra suficiente actividad antitumoral contra el recurrente de grado II o III para justificar una mayor investigación en fase III o como terapia adyuvante para la enfermedad recién diagnosticada después de la resección y radioterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Age 18 or older.
    ?Histological diagnosis of WHO grade II (chordoid meningioma, clear cell meningioma, atypical meningioma) or WHO grade III (papillary meningioma, rhabdoid meningioma, anaplastic/malignant meningioma) according to WHO 2007 classification.
    ?Radiologically documented progression of any existing tumor (growth > 25% in the last year) or appearance of new lesions (including intra- and extracranial manifestations).
    ?Measurable disease (10 x10 mm) on cranial MRI or CT thorax/abdomen no more than 2 weeks prior to randomization
    ?WHO performance status 0-2
    ?Adequate liver, renal and hematological function within 2 weeks prior to randomization, defined as:
    ?Neutrophils ? 1.5 x 109/L, hemoglobin ? 9 g/dL or hemoglobin ? 5.6 mmol/L, platelets ? 100 x 109/L
    ?Total Bilirubin ? ULN, SGPT/ALT and SGOT/AST ? 2.5 x ULN
    ?Alkaline phosphatase ? 2.5 x ULN; if alkaline phosphatase > 2.5 ULN, hepatic isoenzymes 5-nucleotidase or gamma glutyamyltransferase (GGT) must be within the normal range
    ?Albumin ? 30 g/L
    ?Serum creatinine ? 1.5 x ULN
    ?Creatinine clearance > 30 ml/min as calculated by Cockcroft and Gault formula (see Appendix E)
    ?Creatine phosphokinase (CPK) ? 2.5 x ULN
    ?Normal cardiac function (LVEF assessed by MUGA or ECHO within normal range of the institution), normal 12 lead ECG (without clinically significant abnormalities). The following unstable cardiac conditions are not allowed:
    ?Congestive heart failure
    ?Angina pectoris
    ?Myocardial infarction within 1 year before registration/randomization
    ?Uncontrolled arterial hypertension defined as blood pressure ? 150/100 mm Hg despite optimal medical therapy
    ?Arrhythmias clinically significant
    ?Life expectancy of at least 9 weeks
    ?Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last study treatment. Men who are fertile must use effective contraception during treatment with trabectedin and for 5 months thereafter. A highly effective method of birth control is defined as one which results in low failure rate, i.e. less than 1% per year, when used consistently and correctly.
    ?Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 3 months after the last study treatment.
    ?Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    ?Patients with a buffer range from the normal values of +/- 5 % for hematology and +/- 10% for biochemistry are acceptable. A maximum of +/- 2 days for timelines may be acceptable
    ?Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
    ? Mayores o igual a 18 años de edad
    ? Diagnóstico histológico de grado II de la OMS (meningioma cordoide, meningioma de células claras, meningioma atípico) o de grado III de la OMS (meningioma papilar, meningioma rabdoide, meningioma anaplásico/maligno) según la clasificación del 2007 de la OMS.
    ? Progresión documentada radiológicamente de cualquier tumor existente (crecimiento > 25% durante el último año) o aparición de lesiones nuevas (incluyendo manifestaciones intra y/o extracraneales)
    ? Enfermedad medible (10 x10 mm) en una RM craneal en una ventana no superior a 2 semanas antes de la aleatorización.
    ? Estado funcional de la OMS 0-2.
    ? Función hematológica, renal y hepática adecuada durante las dos semanas anteriores a la aleatorización, definida por:
    ? Neutrófilos ? 1,5 x 109/L, hemoglobina ? 9 g/dL o hemoglobina
    ? 5,6 mmol/L, plaquetas ? 100 x 109/L
    ? Bilirrubina total ? 1xULN, SGPT/ALT y SGOT/AST ? 2,5 x el límite superior normal (ULN)
    ? Fosfatasa alcalina ? 2,5 x ULN; si la fosfatasa alcalina > 2,5 ULN, la 5'-nucleotidasa de isoenzimas hepáticas o ?-glutamil-transferasa (?-GT) se deben encontrar dentro de un margen de normalidad
    ? Albúmina: > 30 g/L
    ? Creatinina en suero ? 1.5 x ULN
    ? Aclaramiento de creatinina > 30 ml/min por el cálculo según la fórmula de Cockcroft y Gault (ver Apéndice E)
    ? Creatina fosfocinasa (CPK) ? 2.5 x ULN
    ? Función cardíaca normal (fracción de eyección ventricular izquierda valorada por una ventriculografía nuclear o una ecocardiografía dentro de la normalidad según los rangos estándar de la institución), ECG de 12 derivaciones habituales (sin anormalidades sintomáticas significativas). La inestabilidad de los siguientes trastornos cardíacos no está permitida:
    ? Insuficiencia cardíaca congestiva
    ? Angina de pecho
    ? Infarto de miocardio en un plazo de 1 año antes del registro/aleatorización.
    ? Hipertensión arterial incontrolada definida como presión arterial ?
    150/100 mm Hg pese al tratamiento médico óptimo
    ? Arritmias clínicamente significativas
    ? Esperanza de vida de no menor de 9 semanas
    ? Se debe efectuar a las mujeres potencialmente fértiles una prueba de embarazo en suero (u orina) negativa en las 72 horas previas a la primera dosis del tratamiento del estudio. Las pacientes con potencial fértil/reproductivo deberán utilizar un método anticonceptivo eficaz, según lo defina el investigador, durante su participación en el estudio y hasta 3 meses después del último tratamiento. Los hombres fértiles deben utilizar anticonceptivos eficaces durante el tratamiento con trabectedina y en los 5 meses posteriores. Un método anticonceptivo muy efectivo es aquel que presenta un bajo índice de fallos (menos del 1% anual) cuando se utiliza de manera constante y correcta.
    ? Las pacientes mujeres que dan el pecho deben interrumpir la lactancia natural antes de la primera dosis del tratamiento del estudio y hasta tres meses después del último tratamiento del estudio.
    ? Ausencia de condiciones psicológicas, familiares, sociológicas o geográficas que pudieran obstaculizar potencialmente el cumplimiento con el protocolo de estudio y programa de seguimiento; estas condiciones se comentarán con el paciente antes del registro en el ensayo.
    ? Se aceptan pacientes con un rango intermedio de los valores normales de +/- 5 % para hematología y +/- 10% para la bioquímica. Se acepta un máximo de +/- 2 días en el plazo de tiempo para las pruebas.
    ? Consentimiento informado por escrito antes de la aleatorización del paciente, conforme a las BPC de la ICH y la normativa local/nacional
    E.4Principal exclusion criteria
    ?More option for local therapy (resection or radiotherapy) after maximal feasible surgery and radiotherapy.
    ?Prior systemic anti-neoplastic therapy for meningioma.
    ?History of any other invasive malignancy within the last 5 years (except adequately treated non-melanoma skin cancer, clinicaly localized and very low risk prostate cancer, and adequately treated cervical intraepithelial neoplasia).
    ?Serious illness or medical conditions, specifically: active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis.
    ?Concomitant use of any other investigational agent or phenytoin.
    ?Known MRI or CT, including contrast media, contraindications.
    ? No presentar más opciones de tratamiento local (resección o radioterapia) tras la máxima cirugía y radioterapia posibles efectuadas.
    ? No haber recibido tratamiento antineoplásico sistémico anterior para el meningioma.
    ? No presentar antecedentes de ninguna otra neoplasia maligna invasiva en un plazo de 5 años (a excepción del cáncer de piel no melanótico clínicamente localizado, cáncer de próstata de muy bajo riesgo, y neoplasia intraepitelial cervical tratada satisfactoriamente)
    ? No presentar enfermedades graves o trastornos médicos, en particular: procesos infecciosos activos, hepatopatía activa crónica, incluyendo hepatitis B, C crónica o cirrosis.
    ? No tomar concomitantemente otras sustancias en estudio o fenitoína
    ? No presentar contraindicaciones conocidas para la realización de RM o TC, ni a los medios de contraste.
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression Free Survival (PFS)
    Supervivencia libre de progresión (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. PFS will be measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. Patients without evidence of progression will be censored at the last follow-up visit date. If a patient received a second anti-tumoral therapy without prior documentation of disease progression, the patient will be censored at the date of starting new anti-tumoral therapy.
    1. PFS se medirán a partir de la fecha de aleatorización hasta la fecha de la primera progresión objetiva o de la fecha de la muerte del paciente lo que ocurra primero. Los pacientes sin evidencia de progresión serán censurados en la última fecha de seguimiento visita. Si un paciente recibió una segunda terapia anti-tumoral sin la documentación previa de progresión de la enfermedad, el paciente va a ser censurado en la fecha de iniciar nueva terapia anti-tumoral.
    E.5.2Secondary end point(s)
    1. Progression Free Survival at 6 months (PFS-6), median PFS (mPFS)
    2. Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration.
    3. Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)
    4. Safety (CTCAE v.4.0)
    5. Health-related Quality of life (HRQol)
    1. Supervivencia libre de progresión durante 6 meses (PFS-6), mediana de PFS (PFSm).
    2. Mejor respuesta global (MRG). Respuesta objetiva (RC/RP), proporción y duración mediana de la respuesta. Respuesta completa (RC), proporción y mediana de la duración.
    3. Supervivencia total (OS), probabilidad de OS a los 6 (OS-6) y 12 (OS-12) meses, OS mediana (OSm).
    4. Seguridad (CTCAE v.4.0)
    5. Calidad de vida relacionada con la salud (CVRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.PFS-6 will be measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first.
    2.BOR will be measured from date of randomization until disease progression.CR/PR will be measured similar to PFS but starting from the time measurement criteria for CR/PR are first met.
    3.From date of randomization up to the date of death (any cause). For patients still alive or lost to f/up at the time of analysis, survival will be censored at last f/up visit date.
    4.From the randomization until 30 days after last protocol treatment administration; or until the start of a new antitumor therapy.
    5.At every scheduled visit, 4 weeks prior to randomization.
    1.PFS-6 se medirá a partir de la fecha de aleatorización hasta la fecha de la primera progresión objetiva o fecha de la muerte del paciente lo que ocurra primero.
    2.BOR se medirá desde la fecha de la asignación al azar hasta progresión de la enfermedad. CR/PR se medirá similar a la SSP, pero a partir de los criterios de medición de tiempo que se reunieron por primera vez para CR / PR.
    3.Desde la randomización hasta la fecha de la muerte (por cualquier causa).Para los pacientes todavía en vida o habiendo perdido el seguido,el paciente va a ser censurado durante la última visita.
    4.Desde la aleatorización hasta 30 días después de la última administración del tratamiento; o hasta el comienzo de una nueva terapia antitumoral.
    5.A cada visita programada,4 semanas antes de la aleatorización.
    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 Yes
    E.6.13.1Other scope of the trial description
    Health-related Quality of life (HRQol)
    Calidad de vida relacionada con la salud (CVRS)
    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. 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after last treatment administration to the last patient on protocol.
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol.
    3. The database has been fully cleaned and frozen for this analysis.
    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
    E.8.9.2In all countries concerned by the trial years3
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 81
    F.4.2.2In the whole clinical trial 86
    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)
    Treatment should be given as per the protocol until disease progression, unacceptable toxicity or patient refusal. After progression, treatment is at the discretion of the treating physician.
    El tratamiento debe darse de acuerdo al protocolo hasta que haya progresión, efectos secundarios excesivos o rechazo por parte del paciente.
    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 Decision2015-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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