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    Summary
    EudraCT Number:2015-003047-19
    Sponsor's Protocol Code Number:Sym004-09
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-03
    Trial results View 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 number2015-003047-19
    A.3Full title of the trial
    An Open label, Multi-Center Phase 1b/2a Trial Investigating Different Doses of Sym004 in Combination with FOLFIRI in Patients with Metastatic Colorectal Cancer Progressing after First-Line Therapy
    Ensayo multicéntrico, abierto, en fase Ib/IIa en el que se investigan distintas dosis de Sym004 combinadas con FOLFIRI en pacientes con cáncer colorrectal con metástasis en progresión tras el tratamiento de primera línea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sym004 in Combitation with FOLFIRI (chemotherapy regimen) in metastatic colorectal cancer
    Sym004 en combinación con FOLFIRI (regimen de quimioterapia) en cáncer colorrectal metastasico
    A.4.1Sponsor's protocol code numberSym004-09
    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 SponsorSymphogen A/S
    B.1.3.4CountryDenmark
    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 supportSymphogen A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSymphogen A/S
    B.5.2Functional name of contact pointIvan Horak
    B.5.3 Address:
    B.5.3.1Street AddressPederstrupvej 93
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.4Telephone number4520552604
    B.5.6E-mailidh@symphogen.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 No
    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 nameSym004
    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 INNFutuximab
    D.3.9.1CAS number 1310460-85-5
    D.3.9.2Current sponsor code992 DS
    D.3.9.3Other descriptive nameChimeric IgG anti-EGFR mAb (992)
    D.3.9.4EV Substance CodeSUB177082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9 to 18
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNModotuximab
    D.3.9.1CAS number 1310460-86-6
    D.3.9.2Current sponsor code1024 DS
    D.3.9.3Other descriptive nameChimeric IgG anti-EGFR mAb (1024)
    D.3.9.4EV Substance CodeSUB177082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9 to 18
    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.2.1.2Country 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 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 INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.2Current sponsor codeIrinotecan
    D.3.9.4EV Substance CodeSUB08295MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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.2.1.2Country 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 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 INNFolinic acid
    D.3.9.1CAS number 1492-18-8
    D.3.9.2Current sponsor codeFolinic Acid (FA)
    D.3.9.3Other descriptive nameFOLINIC ACID
    D.3.9.4EV Substance CodeSUB13910MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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: 4
    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.2.1.2Country 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 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 INNFluorouracil
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code5-Fluorouracil (5-FU)
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number400 to 2400
    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 with locally advanced or metastatic CRC, wild type KRAS/NRAS (exon 2, 3, 4) will be enrolled.
    Se inscribirán pacientes con CCR de progresión local o metastásico, con genes KRAS/NRAS de tipo salvaje (exones 2, 3, 4).
    E.1.1.1Medical condition in easily understood language
    Colorectal Cancer
    Cancer Colorrectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective of Dose-Escalation Phase (Phase 1b):
    To determine the MTD and RP2D of Sym004 when administered by intravenous (iv) infusion every second week in combination with a standard dosing regimen of FOLFIRI (folinic acid, 5-flurouracil, irinotecan) to patients with locally advanced or metastatic colorectal cancer (CRC).

    Primary Objective of Dose-Expansion Phase (Phase 2a):
    To evaluate the antineoplastic effect of Sym004 when administered at the RP2D in combination with FOLFIRI to patients with locally advanced or metastatic CRC.
    Establecer la DMT y la DRF2 de Sym004 cuando se administra por infusión IV cada dos semanas en combinación con una pauta posológica estándar de FOLFIRI (ácido fólico [AF; leucovorina], 5-fluorouracilo (5-FU), irinotecán) para pacientes con CCR metastásico o de progresión local.
    E.2.2Secondary objectives of the trial
    Phase 1b:
    ? To determine the safety and tolerability of Sym004 when administered in combination with a standard dosing regimen of FOLFIRI
    ? Evaluation of the immunogenicity of Sym004
    ? Characterization of the PK profile of Sym004
    ? Preliminary evaluation of the antineoplastic effect of Sym004 plus FOLFIRI as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Phase 2a:
    ? Further evaluation of the safety and tolerability of Sym004 when administered at the RP2D in combination with FOLFIRI
    ? Continued evaluation of the immunogenicity of Sym004
    Fase I b
    Establecer la seguridad y tolerabilidad de Sym004 al ser administrado en combinación con una pauta posológica estándar de FOLFIRI
    Evaluar de la inmunogenicidad de Sym004
    ? Caracterizar del perfil FC de Sym004
    ? Evaluación preliminar del efecto antineoplásico de Sym004 más FOLFIRI tal como se evalúa en los criterios de evaluación de la respuesta en tumores sólidos (RECIST v1.1)

    Fase 2a:
    Evaluación adicional de la seguridad y tolerabilidad de Sym004 al administrarse en DRF2 combinado con FOLFIRI
    ? Evaluación continuada de la inmunogenicidad de Sym004
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    ? Failed* treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1.
    Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen.
    or
    Failed* adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1.
    *Failure is defined as radiologic progression

    ? Eligible for FOLFIRI
    ? Measurable disease according to RECIST v1.1
    Estado general (EG) de 0-1 según la escala del grupo de oncología de la cooperativa del este (ECOG).
    Fracaso* en el tratamiento de enfermedad de progresión local o metastásica con tratamiento de primera línea combinado de oxaliplatino y fluoropirimidina, con o sin bevacizumab, durante el tratamiento o < 3 meses tras la última dosis del tratamiento de primera línea y en < 3 meses de C1/D1.
    Los pacientes que interrumpan el tratamiento de primera línea debido a toxicidad podrán inscribirse en caso de que la progresión ocurra en < 6 meses después de la última dosis de la pauta de tratamiento de primera línea.
    O bien:
    Fracaso* en el tratamiento adyuvante en combinación con oxaliplatino y fluoropirimidina durante el tratamiento o en < 6 meses tras la última dosis de oxaliplatino y en el plazo de < 6 meses de C1/D1.
    *El fracaso de define como progresión radiológica
    E.4Principal exclusion criteria
    ? Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11)
    ? Any antineoplastic agent (standard or investigational) within 4 weeks prior to first administration of trial treatments
    ? Significant gastrointestinal abnormalities, as per defined criteria
    ? Significant cardiovascular disease, as per defined criteria
    ? Abnormal hematologic, renal or hepatic function, as per defined criteria
    Tratamiento previo con anticuerpos anti-EGFR, inhibidores de moléculas pequeñas anti-EGFR o irinotecán (CPT-11)
    Cualquier agente antineoplásico (estándar o en estudio) en las 4 semanas antes de C1/D1
    Anormalidades gastrointestionales significativas definidas según criterios.
    Enfermedad cardiovascular significativa definidas según criterio
    Funcion hematológica, renal o hepática definidas según criterio
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Endpoint of the Dose-Escalation Phase is the occurrence of Dose-Limiting Toxicities (DLT) observed during Cycle 1 of Sym004 administration in combination with FOLFIRI.

    The Primary Endpoint of the Dose-Expansion Phase is confirmed objective antitumor response.
    El criterio de valoración principal de la fase de incremento de la dosis es la aparición de toxicidades limitantes de la dosis (TLD) observadas durante el Ciclo 1 de la administración de Sym004 en combinación con FOLFIRI.

    El criterio de valoración principal de la fase de expansión de la dosis es la confirmación de respuesta antitumoral objetiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1b- 1 year
    Phase 2a- 2.5 year
    Fase Ib - 1 año
    Fase 2a - 2,5 años
    E.5.2Secondary end point(s)
    Safety
    ? Nature, incidence and severity of AEs measured from baseline to end of trial participation
    NOTE: Adverse Events are graded by the Investigator according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.4.03, in the following referred to as CTCAE)
    ? AEs leading to dose-reductions, dose delays and permanent treatment cessation
    ? Changes in safety laboratory values from baseline to end of trial participation
    ? Changes in vital signs and physical examinations from baseline to end of trial participation
    ? Occurrence of anti-drug antibodies (ADA) to Sym004 measured in serum at selected timepoints from baseline to end of trial participation

    Anti-tumor Response
    ? Documented Objective Response (OR), defined as documented Partial Response (PR) or Complete Response (CR)
    ? Duration of OR from time of first PR or CR to progressive disease (PD)
    ? Changes in sum of diameters of target lesions from baseline to end of trial participation
    ? Stable Disease (SD) for > 4 months
    ? Time to documented disease progression, death, patient withdrawal or end of trial participation, whichever comes first

    Pharmacokinetic Assessment (Dose Escalation only)
    ? PK endpoints, derived from the concentration-time curves of Sym004, mAb992 and mAb1024, respectively after the first and fourth infusion of Sym004:
    AUCNorm, 0-336h Dose-normalized area under the concentration-time curve from End of Infusion (EOI) to 336 hours
    AUC0-336h Area under the concentration-time curve from EOI to 336 hours
    Cmax Maximum concentration
    Tmax: Time to reach maximum concentration
    Ctrough Trough concentration
    T½ Elimination half-life
    CL Clearance
    V Volume of distribution

    Pharmacodynamic and Biomarker Assessment
    a. Urine and peripheral blood collection for assessment of biomarkers related to the EGFR pathway
    b. Other potential biomarkers to be determined (i.e. genes, gene transcripts and proteins of the receptor tyrosine kinases (RTKs))
    ? La naturaleza, incidencia e intensidad de los AA medidos desde el inicio hasta el fin de la participación en el ensayo
    NOTA: los AA los puntúa el investigador de acuerdo con los criterios de terminología común para acontecimientos adversos según el Instituto Nacional del Cáncer (NCI-CTCAA v.4.03, referidos como CTCAA de ahora en adelante)
    ? AA que desencadenen disminuciones de la dosis, retrasos de la dosis y cese permanente del tratamiento
    ? Cambios en los valores de seguridad del laboratorio desde el inicio hasta el final de la participación en el ensayo
    ? Cambios en las constantes vitales y exploraciones físicas desde el inicio hasta el final de la participación en el ensayo
    ? La incidencia de anticuerpos antifármaco (AAF) contra Sym004 medida en el suero en momentos seleccionados desde el inicio hasta el final de la participación en el ensayo
    Respuesta antitumoral
    ? Respuesta objetiva (RO) documentada, definida como respuesta parcial (RP) documentada o respuesta completa (RC)
    ? Duración de la RO desde el momento de la primera RP o RC hasta la enfermedad progresiva (EP)
    ? Cambios en la suma de diámetros de las lesiones diana desde el inicio hasta el final de la participación en el ensayo
    ? Enfermedad estable (EE) durante > 4 meses
    ? Tiempo hasta la progresión de la enfermedad documentada, muerte, retirada del paciente o final de participación en el ensayo, lo que ocurra antes
    Evaluación farmacocinética (solo incremento de la dosis)
    ? Criterios de valoración FC, derivados de las curvas de concentración-tiempo de Sym004, ACM992 y ACM1024, respectivamente, tras la primera y cuarta infusión de Sym004:
    ABCnorm, 0-336h Área bajo la curva de concentración-tiempo normalizada por la dosis desde el final de la infusión (FDI) hasta 336 horas
    ABC0-336h Área bajo la curva de concentración-tiempo desde el FDI hasta 336 horas
    Cmáx Concentración máxima
    Tmáx Tiempo hasta alcanzar la concentración máxima
    Cmín Concentración mínima
    t½ Semivida de eliminación
    ACL Aclaramiento
    V Volumen de distribución
    Evaluaciones farmacodinámicas y de biomarcadores
    a. Recogida de orina y sangre periférica para evaluar biomarcadores relacionados con la vía EGFR
    b. Otros biomarcadores potenciales a determinar (por ejemplo, genes, transcriptores génicos y proteínas del receptor de la tirosina quinasa [RTK])
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PK Analysis - 1 year
    -Biomarker - 2 year
    -Safety - 2.5 year
    -Tumor Response - 2 year
    - Analisis farmacinético - 1 año
    - Biomarcador - 2 años
    - seguridad - 2,5 años
    - respuesta tumoral - 2 años
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib/IIa
    Ib/IIa
    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 concerned3
    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 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
    Spain
    United States
    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 trial will be reached at the latest 1 month (28 +7 days) after the last patient has been withdrawn from trial treatments.
    El fin de ensayo tendrá lugar al menos 1 mes (28 + 7 dias) antes de que el último paciente haya sido retirado de los tratamientos del ensayo
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 10
    F.4.2.2In the whole clinical trial 50
    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)
    End of Treatment/Follow-up: Once both Sym004 and FOLFIRI have been discontinued an End of Treatment (EOT) Visit will be performed within 10 days from the decision to withdraw treatment.
    A follow-up visit will be performed 1 month after the last administration of Sym004/FOLFIRI (i.e. only after both treatments have been discontinued). This One Month Follow-up (1M FUP) visit will constitute the end of trial participation for the patient.
    Fin de ensayo/Seguimiento: una vez que se haya discontinuado Sym004 y FOLFIRI tendrá lugar una visita fin de ensayo en los 10 días siguientes a la decisión de retirada del tratamiento
    Se realizará una visita de seguimiento 1 mes después de la última administración de Sym004/FOLFIRI (p.ej. solo después de que ambos tratamientos se hayan discontinuado). Esta visita de seguimiento del mes 1 (1M FUO) consitituirá el fin de la participación del paciente en el ensayo.
    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 Decision2016-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-15
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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