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    Summary
    EudraCT Number:2012-001106-26
    Sponsor's Protocol Code Number:EC11-444-OSTEOSARC
    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:2012-04-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-001106-26
    A.3Full title of the trial
    PHASE II MULTICENTRIC AND PROSPECTIVE TRIAL WITH GEMCITABINE AND RAPAMYCIN IN SECOND LINE OF METASTATIC OSTEOSARCOMA
    ENSAYO FASE II MULTICENTRICO Y PROSPECTIVO CON GEMCITABINA Y RAPAMICINA EN SEGUNDA LÍNEA DE OSTEOSARCOMA METASTÁSICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TRIAL PHASE II MULTICENTER FOR CANCER PATIENTS DIAGNOSED WITH OSTEOSARCOMA WITH METASTASIS WHO HAVE ALREADY BEEN TREATED PREVIOUSLY
    ESTUDIO FASE II MULTICENTRICO PARA PACIENTES DIAGNOSTICADOS DE CANCER TIPO OSTEOSARCOMA CON METASTASIS QUE YA HAN SIDO TRATADOS PREVIAMENTE
    A.3.2Name or abbreviated title of the trial where available
    OSTEOSARCOMA METASTASICO PREVIOUSLY TREATED
    OSTEOSARCOMA METASTASICO TRATADOS PREVIAMENTE
    A.4.1Sponsor's protocol code numberEC11-444-OSTEOSARC
    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 SponsorJAVIER MARTÍN BROTO
    B.1.3.4CountrySpain
    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 supportDirección General de Farmacia y Productos Sanitarios del Ministerio de Sanidad, Política Social e Igualdad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSofpromed
    B.5.2Functional name of contact pointPatricio Ledesma
    B.5.3 Address:
    B.5.3.1Street AddressRambla dels Ducs, 13-1
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07003
    B.5.3.4CountrySpain
    B.5.4Telephone number34648414261
    B.5.5Fax number34971570222
    B.5.6E-mailensayos@sofpromed.com
    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 GEMCITABINE
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorio STADA, S.L.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNGEMCITABINE HYDROCHLORIDE
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 RAPAMUNE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LTD.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Oral solution
    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 INNSIROLIMUS
    D.3.9.1CAS number 53123-88-9
    D.3.9.4EV Substance CodeSUB10537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 diagnosed with metastatic osteosarcoma cancer types that have been treated with chemotherapy and have active disease that permits to receive this treatment combination.
    Pacientes diagnosticados de osteosarcoma metastásico que han sido tratados con quimioterapia y tienen enfermedad que permite recibir esta combinación de tratamiento.
    E.1.1.1Medical condition in easily understood language
    Patients with metastatic osteosarcoma cancer that have been treated with standard chemotherapy and have active disease requiring treatment.
    Pacientes diagnosticados de cáncer tipo osteosarcoma metastásico que han sido tratados y tienen enfermedad activa, necesitando recibir tratamiento para su enfermedad.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analyze progression free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated.
    Analizar la supervivencia libre de progresión (SLP), medida como tasa de SLP a los 4 meses, en pacientes con osteosarcoma metastático que han recibido previamente los fármacos más activos en esta enfermedad (metotrexate, cisplatino, adriamicina e ifosfamida) y están en progresión metastática o inoperable.
    E.2.2Secondary objectives of the trial
    Analyze the response rate (RECIST) of the study treatment (gemcitabine-rapamycin combination).
    Analyze the toxicity of the combination.
    Analyze the correlation with predictive biomarkers.
    Analyze the impact of the combination in overall survival.
    Analizar la tasa de respuesta (RECIST) del tratamiento del estudio (combinación gemcitabina-rapamicina).
    Analizar la toxicidad de la combinación.
    Analizar la correlación con biomarcadores predictivos.
    Analizar el impacto de la combinación en la supervivencia global.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must willingly sign the informed consent before any trial tests that may not be part of the usual patient care, knowing the patient that he/she can leave the trial when desired, without this affecting the future attention.
    2. Age equal or superior to 16 years.
    3. Histological diagnosis of high-grade osteosarcoma, metastatic or not operable in progression.
    4. Previous treatment with drugs used in first line: Methotrexate, adriamycin, platin. It is not required having received ifosfamide for inclusion. They may have received mifamurtide in first line. Might have received bifosfonates though they will have to be interrupted 1 month before inclusion.
    5. Measurable disease, according to RECIST criteria.
    6. Functional state 0-2 (ECOG).
    7. Baseline medullary function (hemoglobin > 10 g/dL, leukocytes ? 3.000/mm3, RAN? 1,5 x 109 /l, granulocytes ? 1.500/mm3, platelets ? 100.000/mm3). Acceptable patients with alteration of transaminases ? 2.5 times normal limits, bilirubin total ? LSN, CPK? 2.5 times normal limits, alkalyne phosphatase ? 2.5 times more the normal limits or creatinine levels ? 1,6 mg/dL.
    8. Patients in fertile age (both male and female) must use an effective contraceptive method before study entry and during the study. Furthermore, women must keep contraceptive measures until 3 months after finishing treatment while men must keep these measures up to 5 months after treatment. Pregnancy must be ruled out by urine test (negative pregnancy test) for inclusion in trial.
    9. Normal cardiac functionality, considering the normal ranges of the institution.
    1. El paciente debe firmar voluntariamente el consentimiento informado antes de la realización de cualquier prueba del ensayo que no forme parte de la atención habitual de los pacientes, con el conocimiento por parte del paciente que puede abandonar el ensayo en el momento que quiera, sin que se vea perjudicado en ningún momento su atención posterior.
    2. Edad igual o superior a 16 años.
    3. Diagnóstico histológico de osteosarcoma de alto grado, metastático o no operable en progresión.
    4. Tratamiento previo con las drogas usadas en primera línea: Metotrexate, Adriamicina, Platino. No es imperativo que hayan recibido ifosfamida previamente para su inclusión. Pueden haber recibido Mifamurtida en primera línea. Pueden haber recibido bifosfonatos aunque deberá estar suspendidos al menos 1 mes antes de la inclusión.
    5. Enfermedad medible, de acuerdo con los criterios RECIST.
    6. Estado funcional 0-2 (ECOG).
    7. Función medular basal (hemoglobina > 10 g/dL, leucocitos ? 3.000/mm3, RAN? 1,5 x 109 /l, granulocitos ? 1.500/mm3, plaquetas ? 100.000/mm3). Son aceptables pacientes con alteración de las transaminasas ? 2,5 veces los límites normales, bilirrubina total ? LSN, CPK? 2.5 veces los límites normales, Fosfatasa alcalina ? 2,5 veces más los límites normales o cifras de creatinina ? 1,6 mg/dL.
    8. Los pacientes en edad fértil (tanto los varones como las mujeres) deben usar un método eficaz anticonceptivo antes de la entrada en el estudio y durante la realización del estudio. Además, las mujeres deben mantener las medidas anticonceptivas hasta 3 meses después de finalizar el tratamiento mientras que los varones deben prolongar estas medidas hasta 5 meses después del tratamiento. Debe descartarse embarazo mediante prueba de orina (test de embarazo negativo) para la inclusión en el estudio.
    9. Funcionalidad cardiaca (FEVI) normal, considerando los rangos normales de la institución.
    E.4Principal exclusion criteria
    1. Patients having been irradiated in the target lesions.
    2. Functional state > 2 (ECOG).
    3. Bilirubin levels superior to normal level. Creatinine superior to 1.6 mg/dL.
    4. History of other tumor disease except basal-cell carcinoma or carcinoma in situ of cervix adequately treated.
    5. Serious cardiovascular diseases (Dyspnea >= 2 NYHA).
    6. Systemic pathologies limiting survival to less than 2 years, limiting the availability of the patient, or that may interfere significantly with the treatment toxicity.
    7. Infectious diseases: bacterial, viral or mycotic not controlled.
    8. Pregnant patients or nurturing.
    9. Psychological, familiar, sociological or geographical situations not allowing the fulfilment of the protocol or informed consent.
    10. Patients currenly included in another clinical trial or receiving any agent under investigation.
    11. Patients having participated in a clinical trial and/or having received an agent in investigation in the 30 days previous to inclusion.
    1. Pacientes que hayan sido irradiados en las lesiones diana.
    2. Estado funcional > 2 (ECOG).
    3. Cifras de bilirrubina superior al nivel normal. Creatinina superior a 1,6 mg/dL.
    4. Antecedentes de otra enfermedad neoplasia con excepción de basalioma o carcinoma in situ de cérvix adecuadamente tratados.
    5. Enfermedades cardiovasculares graves (Disnea >= 2 NYHA p.ej.).
    6. Patologías sistémicas de base que limiten la supervivencia a menos de 2 años, que limiten la disponibilidad del paciente, o que puedan, a juicio clínico, interferir de forma significativa con la toxicidad del tratamiento.
    7. Enfermedades infecciosas bacterianas, víricas o micóticas no controladas.
    8. Pacientes embarazadas o lactantes.
    9. Situaciones psicológicas, familiares, sociológicas o geográficas que no permitan el cumplimiento del protocolo o del consentimiento informado.
    10. Pacientes que estén actualmente en otro ensayo clínico o recibiendo cualquier agente en investigación.
    11. Pacientes que hayan participado en un ensayo clínico y/o hayan recibido un agente en investigación en los 30 días anteriores a la inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Analyze progression-free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated.
    Analizar la supervivencia libre de progresión (SLP), medida como tasa de SLP a los 4 meses, en pacientes con osteosarcoma metastático que han recibido previamente los fármacos más activos en esta enfermedad (metotrexate, cisplatino, adriamicina e ifosfamida) y están en progresión metastática o inoperable.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months
    4 meses
    E.5.2Secondary end point(s)
    1. Analyze the response rate (RECIST) of the study treatment (gemcitabine-rapamycin combination).
    2. Analyze the toxicity of the combination.
    3. Analyze the correlation with predictive biomarkers.
    4. Analyze the impact of the combination in the overall survival.
    1. Analizar la tasa de respuesta (RECIST) del tratamiento del estudio (combinación gemcitabina-rapamicina).
    2. Analizar la toxicidad de la combinación.
    3. Analizar la correlación con biomarcadores predictivos.
    4. Analizar el impacto de la combinación en la supervivencia global.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Continuously
    2. Continuously
    3. At the end of trial
    4. Year 3
    1. Contínuamente
    2. Contínuamente
    3. Al final del ensayo
    4. Año 3
    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 Yes
    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 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 concerned11
    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
    The end of the trial will take place in the date of the last visit of the last patient included in the study.
    El final del ensayo tendrá lugar en la fecha de la última visita del último sujeto reclutado en el estudio.
    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
    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: 4
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 19
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state33
    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)
    It is not different from expected normal treatment of the condition.
    No es diferente al tratamiento normal esperado.
    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 Decision2012-07-02
    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 StatusOngoing
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