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    Summary
    EudraCT Number:2013-005155-32
    Sponsor's Protocol Code Number:COSYMO
    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:2017-05-08
    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 number2013-005155-32
    A.3Full title of the trial
    A phase 2, single arm, multi center trial evaluating the efficacy of the combination of sirolimus and cyclophosphamide in metastatic or unresectable myxoid liposarcoma and chondrosarcoma.
    Fase II, muticéntrico, de solo brazo, para evaluar la eficacia del tratamiento con sirolimus y ciclofosfamida en condrosarcoma y liposarcoma mixoide irresecable o metastásico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study testing the combination of sirolimus and cyclophosphamiode
    in chondrosarcoma and myxoid liposarcoma patients
    Estudio que evalúa la combinación de sirolimus y ciclofosfamida en pacientes con condrosarcoma y liposarcoma mixoide.
    A.3.2Name or abbreviated title of the trial where available
    COSYMO
    A.4.1Sponsor's protocol code numberCOSYMO
    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 SponsorGrupo Español de Investigación en Sarcomas (GEIS)
    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 supportPfizer
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportEurosarc
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGEIS
    B.5.2Functional name of contact pointMelissa Fernandez Pinto
    B.5.3 Address:
    B.5.3.1Street Addressc/ Diego de León 47, Ed Melior
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number0034644289162
    B.5.5Fax number0034918388588
    B.5.6E-mailmelissa.crc@grupogeis.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 Rapamune
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameSirolimus
    D.3.4Pharmaceutical form Coated 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 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Endoxan
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNEndoxan
    D.3.9.1CAS number 6055-19-2
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB16414MIG
    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.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
    Conventional chondrosarcoma
    Myxoid liposarcoma with PIK3CA mutation or PTEN loss
    Mesenchymal or dedifferentiated chondrosarcoma
    Condrosarcoma convencional
    Liposarcoma mixoide con mutación PIK3CA o ausencia de PTEN
    Condrosarcoma mesenquimal o desdiferenciado
    E.1.1.1Medical condition in easily understood language
    Chondrosarcoma
    Myxoid liposarcoma
    Condrosarcoma
    Liposarcoma mixoide
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the treatment efficiency by growth modulation index
    Evaluar la eficiencia del tratamiento con el índice de crecimiento modulado
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of the sirolimus and
    cyclophosphamide combination
    - To determine the median progression free survival after start of
    treatment till disease progression
    - To determine the overall survival after start of treatment till death
    - Evaluar la seguridad y la tolerabilidad de la combinación de sirolimus y ciclofosfamida.
    - Determinar la mediana de supervivencia libre de progresión desde el inicio del tratamiento hasta la progresión de la enfermedad
    - Determinar la supervivencia global desde el inicio del tratamiento hasta la muerte.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pathologically proven conventional chondrosarcoma
    - Or pathologically proven myxoid liposarcoma with PIK3CA mutation or PTEN loss
    - Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
    - Patients of 18 years and up
    - Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
    - Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L)
    - Availability of archival tumor material for central review
    - Written signed informed consent
    - Ability to adhere to the study visits and all protocol requirements
    - Condrosarcoma convencional confirmado por anatomía patológica.
    - O liposarcoma mixoide con mutación PIK3CA o ausencia de PTEN conformado por anatomía patológica.
    - O Condrosarcoma mesenquimal o desdiferenciado confirmado por anatomía patológica.
    - Pacientes con 18 años o más.
    - Progresión radiológica documentada de acuerdo a los criterios RECIST 1.1 en los últimos 6 meses.
    E.4Principal exclusion criteria
    - Previously treated with an mTOR inhibitor
    - Known to be allergic to cyclophosphamide
    - Life expectancy of less than 3 months
    - No measurable lesions according to RECIST 1.1
    - ECOG Performance status >2
    - Major surgery less than 4 weeks prior to start of treatment
    - Known human immunodeficiency virus (HIV) positivity
    - A decreased renal function with calculated GFR < 30 ml/min
    - Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to an index (or target) lesion within 21 days prior to the first dose of study drug
    - Pregnant or lactating women
    - Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer
    - Previamente tratado con inhibidor de mTOR.
    - Alergia conocida a ciclofosfamida
    - Esperanza de vida menor a 3 meses.
    - Lesión no medible por los criterios RECIST 1.1
    - Estado ECOG>2
    - Cirugía mayor en los últimos 4 meses antes de iniciar el tratameinto.
    - Virus de la inmunodeficiencia humana diagnosticado.
    E.5 End points
    E.5.1Primary end point(s)
    Time to progression during sirolimus/cyclofosfamide treatment (TTP2) divided by time to progression before start of this treatment TTP1 (=growth modulation index)
    Tiempo a la progresión durante el tratamiento de sirolimus/ciclofosfamida (TTP2) entre el tiempo a la progresión del tratameinto anterior (TTP1) = indíce de modulación de crecimeinto)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated with CT-scan every 8 weeks
    Los pacientes serán evaluados con un TAC cada 8 semanas.
    E.5.2Secondary end point(s)
    - Translational exploratory tumour pharmacodynamic analysis
    - Toxicity according to CTC version 4.0
    - Objective response defined as a partial or complete response occurring after start of treatment according to RECIST1.1
    - Time to progression according to RECIST 1.1
    - Overall survival from start of treatment until death
    - Análisis farmacodinámico de la exploración traslacional tumoral.
    - Toxicidad de acuerdo a la guía CTC versión 4.0
    - Respuesta objetiva definida como respuesta parcial o completa ocurrida tras el inicio del tratamiento de acuerdo a los criterios RECIST 1.1
    - Supervivencia global desde el inicio del tratamiento hasta el exitus.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. every 4 weeks on outpartient clinic visit
    2. every 8 weeks with CT-scan
    1. Cada 4 semanas con visita clínica
    2. Cada 8 semanas con TAC
    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 No
    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 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 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 concerned6
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state50
    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)
    None
    Ninguno
    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 Decision2017-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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