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    Summary
    EudraCT Number:2017-003242-25
    Sponsor's Protocol Code Number:GITuD-20172019
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-01-04
    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 number2017-003242-25
    A.3Full title of the trial
    Analysis of 2nd line panitumumab + FOLFIRI efficacy in wild type RAS converted subjects from initially mutated RAS subjects with metastatic colorectal cancer treated in 1st line with standard FOLFOX + bevacizumab treatment.
    Estudio de fase II para evaluar la eficacia de panitumumab + FOLFIRI en el tratamiento de segunda línea de pacientes con cáncer colorrectal metastásico con gen RAS nativo, inicialmente mutado, que habían recibido tratamiento estándar con FOLFOX + bevacizumab en la primera línea de tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analysis of 2nd line panitumumab + FOLFIRI efficacy in wild type RAS converted subjects from initially mutated RAS subjects with metastatic colorectal cancer treated in 1st line with standard FOLFOX + bevacizumab treatment.
    Estudio de fase II para evaluar la eficacia de panitumumab + FOLFIRI en el tratamiento de segunda línea de pacientes con cáncer colorrectal metastásico con gen RAS nativo, inicialmente mutado, que habían recibido tratamiento estándar FOLFOX + bevacizumab en la primera línea de tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    CONVERTIX
    A.4.1Sponsor's protocol code numberGITuD-20172019
    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 SponsorASOCIACION GITuD
    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 supportAMGEN S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTRIAL FORM SUPPORT SL
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressCONSELL DE CENT 334-336,4ªPLANTA
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number34931850200274
    B.5.5Fax number34931850257
    B.5.6E-mailanna.colome@tfscro.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 VECTIBIX 20mg/ml concentrado para solución para infusión
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    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.3.1Product namePANITUMUMAB
    D.3.2Product code PANITUMUMAB
    D.3.4Pharmaceutical form 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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman IgG2 monoclonal antibody
    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 Irinotecan
    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.3.1Product nameIrinotecan
    D.3.2Product code Irinotecan
    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 HYDROCHLORIDE TRIHYDRATE
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB45873
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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 Yes
    D.3.11.13.1Other medicinal product typeCytostatic
    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 Leucovorin
    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.3.1Product nameFolinic Acid
    D.3.2Product code Folinic Acid
    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.3.9.3Other descriptive nameFOLINIC ACID
    D.3.9.4EV Substance CodeSUB13910MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeCytostatic
    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.2.1.1.1Trade name 5-FLUOROURACIL
    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.3.1Product name5-FLUOROURACIL
    D.3.2Product code 5-FLUOROURACIL
    D.3.4Pharmaceutical form
    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.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeCytostatic.
    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
    Wild-type RAS metastatic colorectal cancer (mCRC)
    Cáncer colorrectal metastásico (CCRm) con RAS no mutado
    E.1.1.1Medical condition in easily understood language
    Wild-type RAS metastatic colorectal cancer (mCRC)
    Cáncer colorrectal metastásico (CCRm) con RAS no mutado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    To estimate progression-free survival (PFS) in second- line treatment with panitumumab + FOLFIRI in wild type RAS mCRC patients who had mutant RAS at initiation of the first-line (standard FOLFOX + bevacizumab treatment)
    Calcular la supervivencia libre de progresión (SLP) con el tratamiento de segunda línea con panitumumab + FOLFIRI en los sujetos con CCRm con RAS no mutado que presentaban mutación en RAS al inicio del tratamiento de primera línea (tratamiento estándar FOLFOX + bevacizumab).
    E.2.2Secondary objectives of the trial
    To estimate the conversion rate from wild tpe to mutant RAS status at disease progression after second-line treatment
    To estimate the overall response rate (ORR)
    To evaluate the disease control rate (DCR)
    To estimate the proportion of subjects with early tumour shrinkage (ETS)
    To evaluate the depth of response (DpR)
    To assess the duration of response (DoR)
    To assess the time to response (TTR)
    To estimate time to treatment failure (TTF)
    To estimate overall survival (OS)
    To assess the safety and tolerability
    Biomarkers analysis by liquid bipsies
    Estimar la tasa de conversión de RAS no mutado a mutado en el momento de la progresión de la enfermedad tras el tratamiento de segunda línea
    Estimar la tasa de respuesta global (TRG)
    Evaluar la tasa de control de la enfermedad (TCE)
    Estimar el porcentaje de sujetos con reducción tumoral temprana (ETS)
    Evaluar la profundidad de la respuesta (PdR)
    Evaluar la duración de la respuesta (DR)
    Evaluar el tiempo hasta la respuesta (TTR)
    Estimar el tiempo hasta el fracaso terapéutico (TFT)
    Estimar la supervivencia global (SG)
    Evaluar la seguridad y la tolerabilidad
    Análisis de biomarcadores mediante biopsias líquidas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Man or woman at least 18 years old
    2)Capable of understand, sign and date an informed consent approved by an (Independent Ethics Committee) IEC
    3)Histologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease
    4)At least one unidimensionally measurable lesion of at least 10 mm per Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1)
    5)Patients who received only one prior chemotherapy regimen for mCRC consisting of first-line FOLFOX+ bevacizumab
    6)Radiographically confirmed disease progression after first-line FOLFOX + bevacizumab chemotherapy
    7)Patients who had mutated RAS status confirmed as per standard of care according to international guidelines prior to first-line initiation
    8)Patients candidate to second-line treatment and with wild-type RAS status in liquid biopsy confirmed prior to second-line initiation
    9)Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    10)Adequate bone marrow function: neutrophils ≥1.5 x109/ L; platelets ≥100 x109/L; haemoglobin ≥9 g/dL
    11)Hepatic, renal and metabolic function as follows:
    - Total bilirubin count ≤1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 x ULN
    - Renal function, calculated as creatinine clearance or 24-hour creatinine clearance ≥ 50 mL/min
    - Magnesium > lower limit of normal (LLN)
    1) Hombres o mujeres de al menos 18 años
    2) Capacidad para comprender, firmar y fechar un consentimiento informado aprobado por un CEIm (Comité Ético de Investigación con medicamentos)
    3) Adenocarcinoma de colon o recto confirmado histológicamente en sujetos con enfermedad metastásica (M1) irresecable
    4) Al menos una lesión medible unidimensionalmente de al menos 10 mm según criterios de evaluación de la respuesta en tumores sólidos (RECIST) (versión 1.1)
    5) Pacientes que hayan recibido solo una pauta de quimioterapia previa contra el CCRm consistente en quimioterapia de primera línea FOLFOX + bevacizumab
    6) Progresión de la enfermedad confirmada radiológicamente después de la quimioterapia de primera línea FOLFOX + bevacizumab
    7) Pacientes con un estado de RAS mutado confirmado por los métodos estándar según las directrices internacionales antes del inicio del tratamiento de primera línea
    8) Pacientes candidatos al tratamiento de segunda línea y con estado de RAS no mutado en la biopsia líquida confirmado antes del inicio del tratamiento de segunda línea
    9) Estado funcional según la escala ECOG (Eastern Cooperative Oncology Group) de 0 a 2
    10) Función medular aceptable: neutrófilos ≥ 1,5 × 109/l; recuento de plaquetas ≥ 100 × 109/l; hemoglobina ≥ 9 g/dl
    11) Función hepática, renal y metabólica como sigue:
    - Valor de bilirrubina total ≤ 1,5 veces el límite superior de la normalidad (LSN), alanina-aminotransferasa (ALT) y aspartato-aminotransferasa (AST) < 5 × LSN
    - Función renal, calculada como aclaramiento de creatinina o aclaramiento de creatinina de 24 horas ≥ 50 ml/min
    - Magnesio > límite inferior de la normalidad (LIN)
    E.4Principal exclusion criteria
    1)History of prior or concurrent central nervous system (CNS) metastases
    2)History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years before the inclusion in the study
    3)Unresolved toxicities of a previous systemic treatment that, in the opinion of the investigator, cause the subject unfit for inclusion
    4)Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, cetuximab) or prior irinotecan therapy
    5)Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia
    6)History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computerized tomography (CT)
    7)Treatment for systemic infection within 14 days before the start of study treatment
    8)Acute or subacute intestinal occlusion and/or active inflammatory bowel disease or other bowel disease that causes chronic diarrhoea (defined as grade ≥ 2 diarrhoea according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03)
    9)Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment
    10)History of Gilbert disease or known dihydropyrimidine deficiency syndrome
    11)History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results.
    12)Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
    13)Any disorder that compromises the subject’s ability to provide written informed consent and/or comply with study procedures
    14)Any investigational agent within 30 days prior to inclusion
    15)Pregnant or breastfeeding woman
    16)Major surgery (excluding diagnostic biopsy or placement of a central venous catheter) and/or radiotherapy within 28 days prior to inclusion in the study.
    17)Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g diaphragm plus condoms) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and 1 month for men
    18)The subject is unwilling or unable to meet the requirements of the study
    19)Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule. These conditions should be discussed with the subject before inclusion in the trial
    1) Antecedentes de metástasis previas o concomitantes del sistema nervioso central (SNC)
    2) Antecedentes de otro cáncer primario, excepto: cáncer de cuello uterino in situ o cáncer de piel no melanomatoso resecado con fines curativos, o cualquier otro tumor sólido primario tratado con fines curativos, sin enfermedad activa conocida ni administración de tratamiento durante ≥ 5 años antes de la inclusión en el estudio.
    3) Toxicidades no resueltas de un tratamiento sistémico previo que, en opinión del investigador, impiden que el sujeto sea apto para su inclusión.
    4) Tratamiento previo con anticuerpos contra el receptor del factor de crecimiento epidérmico (EGFR) (p. ej., cetuximab) o tratamiento previo con irinotecán
    5) Enfermedad cardiovascular significativa, que incluye angina de pecho inestable o infarto de miocardio en los 12 meses previos al inicio del tratamiento del estudio o antecedentes de arritmia ventricular
    6) Antecedentes de neumonitis intersticial o fibrosis pulmonar, o signos de neumonitis intersticial o fibrosis pulmonar en la tomografía computarizada (TC) de tórax inicial
    7) Tratamiento contra una infección sistémica en los 14 días previos al inicio del tratamiento del estudio
    8) Oclusión intestinal aguda o subaguda, enfermedad inflamatoria intestinal activa u otra enfermedad intestinal que cause diarrea crónica (definida como diarrea de grado ≥ 2 según los Criterios Terminológicos Comunes para la clasificación de los Acontecimientos Adversos (CTCAE) v 4.03)
    9) Indicios de reacción de hipersensibilidad aguda previa, de cualquier grado, a cualquiera de los componentes del tratamiento.
    10) Antecedentes de enfermedad de Gilbert o síndrome de deficiencia de dihidropirimidina conocido
    11) Antecedentes de cualquier enfermedad que pueda aumentar los riesgos asociados a la participación en el estudio o que pueda interferir en la interpretación de los resultados del estudio
    12) Resultado positivo en la prueba de detección del virus de la inmunodeficiencia humana, el virus de la hepatitis C o infección crónica activa por el virus de la hepatitis B
    13) Cualquier trastorno que afecte a la capacidad del sujeto para proporcionar el consentimiento informado por escrito o para cumplir con los procedimientos del estudio
    14) Cualquier fármaco en investigación en los 30 días anteriores a la inclusión
    15) Mujeres embarazadas o en periodo de lactancia
    16) Cirugía mayor (excepto biopsia diagnóstica o colocación de un catéter venoso central) o radioterapia en los 28 días anteriores a la inclusión en el estudio.
    17) Varón o mujer en edad fértil que no acepte usar métodos anticonceptivos adecuados, es decir, métodos de doble barrera (p. ej., diafragma más preservativo) o practicar abstinencia durante el estudio y los 6 meses siguientes a la última administración de la medicación del estudio para las mujeres y 1 mes en el caso de los varones
    18) El sujeto no quiere o no puede cumplir los requisitos del estudio.
    19) Afecciones psicológicas y circunstancias geográficas, familiares o sociológicas que podrían impedir el cumplimiento del protocolo del estudio y el calendario de seguimiento. Estas circunstancias se comentarán con el sujeto antes de su inclusión en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    PFS defined as the time from second-line initiation to progression or death.
    SLP, definida como el tiempo transcurrido desde el inicio del tratamiento de segunda línea hasta la progresión de la enfermedad o la muerte
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study
    Fin de Estudio
    E.5.2Secondary end point(s)
    •Conversion rate of RAS status at disease progression (or end of second-line treatment for other reasons) from the status at second-line initiation.
    •Proportion of subjects with an objective response (complete or partial response) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
    •Proportion of subjects with disease control (complete response, partial response or stable disease)
    •ETS with two cut-off set at 20% and 30% (RECIST 1.1) at the first tumour evaluation (week 8)
    •DpR measured as the maximum decrease in target measurement (RECIST1.1) all over the course of evaluation
    •DoR defined as time from first confirmed objective response to radiologic disease progression per RECIST 1.1 criteria or death. For participants who responded and have not progressed or died, duration of response will be censored at their last evaluable disease assessment date.
    •TTR defined as the time from second-line treatment initiation to the date of first confirmed objective response per RECIST 1.1 criteria.
    •TTF defined as the time from second-line treatment initiation until progression, death or discontinuation due to toxicity
    •OS defined as the time from the date of second-line treatment initiation to the date of death, with participants alive or lost to follow-up at the analysis data cut-off date censored at their last contact date
    •Safety assessment will consist of monitoring adverse events (AEs), including serious adverse events (SAEs) and laboratory safety parameters. AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
    • Tasa de conversión del estado de RAS en el momento de la progresión de la enfermedad (o al final del tratamiento de segunda línea por otros motivos) respecto al estado al inicio del tratamiento de segunda línea.
    • Porcentaje de sujetos con respuesta objetiva (respuesta completa o parcial) según los criterios de evaluación de la respuesta en tumores sólidos (RECIST) 1.1
    • Porcentaje de sujetos con control de la enfermedad (respuesta completa, respuesta parcial o enfermedad estable)
    • ETS con dos valores de corte del 20% y 30 % (RECIST 1.1) en la primera evaluación tumoral (semana 8)
    • PdR medida como la reducción máxima en la medición de la lesión diana (RECIST1.1) a lo largo de toda la evaluación
    • La DR se define como el tiempo transcurrido desde la primera respuesta objetiva confirmada hasta la progresión radiológica de la enfermedad según los criterios RECIST 1.1 o la muerte. En el caso de los participantes que presenten respuesta y que no muestren progresión ni fallezcan, la duración de la respuesta se censurará en la fecha de su última evaluación de la enfermedad evaluable.
    • El TTR se define como el tiempo transcurrido desde el inicio del tratamiento de segunda línea hasta la fecha de la primera respuesta objetiva confirmada según los criterios RECIST 1.1.
    • El TFT se define como el tiempo transcurrido desde el inicio del tratamiento de segunda línea hasta la progresión, la muerte o la suspensión definitiva del tratamiento por toxicidad
    • La SG se define como el tiempo transcurrido desde la fecha de inicio del tratamiento de segunda línea hasta la fecha de la muerte; los participantes vivos o que sean pérdidas durante el seguimiento en la fecha de corte se censurarán en la fecha del último contacto.
    • La evaluación de la seguridad consistirá en la monitorización de los acontecimientos adversos (AA), incluidos los acontecimientos adversos graves (AAG) y los parámetros analíticos de seguridad. Los AA se clasificarán según los criterios terminológicos comunes para la clasificación de los acontecimientos adversos (CTCAE) del National Cancer Institute, versión 4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study
    Fin de Estudio
    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 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.8.3 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 concerned8
    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
    Subjects will receive panitumumab plus FOLFIRI until disease progression, unacceptable toxicity, investigator decision or the subject's withdrawal of consent. The study will end when the last subject included in the study have completed the long-term follow-up period.
    Los sujetos recibirán panitumumab más FOLFIRI hasta la progresión de la enfermedad, la aparición de toxicidad inaceptable, la decisión del investigador de suspender el tratamiento o la retirada del consentimiento por el sujeto. El estudio finalizará cuando el último sujeto incluido en el estudio haya completado el periodo de seguimiento a largo plazo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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)
    After study completion, patient will receive expected normal treatment for his/her condition.
    Una vez el paciente haya finalizado el estudio seguirá con su tratamiento habitual para la enfermedad de base.
    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 Decision2018-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-07-30
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