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    Summary
    EudraCT Number:2015-001298-42
    Sponsor's Protocol Code Number:1321
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-11
    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 number2015-001298-42
    A.3Full title of the trial
    A randomised phase II trial of imatinib alternating with
    regorafenib compared to imatinib alone for the first line
    treatment of advanced gastrointestinal stromal tumour (GIST)
    Ensayo aleatorizado de fase II de imatinib alternado con regorafenib en comparación con imatinib solo para el tratamiento de primera línea de tumores estromales gastrointestinales (TEGI) avanzados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised phase II trial of imatinib alternating with
    regorafenib compared to imatinib alone for the first line
    treatment of advanced gastrointestinal stromal tumour (GIST)
    Ensayo aleatorizado de fase II de imatinib alternado con regorafenib en comparación con imatinib solo para el tratamiento de primera línea de tumores estromales gastrointestinales (TEGI) avanzados
    A.3.2Name or abbreviated title of the trial where available
    ALT GIST
    A.4.1Sponsor's protocol code number1321
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02365441
    A.5.4Other Identifiers
    Name:NHMRC CTC Protocol numberNumber:CTC 0122/AGITG AG1013GST
    Name:SSGNumber:ALT-GIST/SSG XXIII
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 supportBayer
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAGITG
    B.4.2CountryAustralia
    B.4.1Name of organisation providing supportEORTC
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEORTC
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741035
    B.5.5Fax number+3227741030
    B.5.6E-mailregulatory@eortc.be
    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.2.5The 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 nameImatinib
    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 INNIMATINIB MESILATE
    D.3.9.1CAS number 220127-57-1
    D.3.9.4EV Substance CodeSUB12517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 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 Stivarga
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRegorafenib
    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 INNRegorafenib
    D.3.9.1CAS number 755037-03-7
    D.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    unresectable metastatic GIST
    Enfermedad metastásica irresecable (GIST)
    E.1.1.1Medical condition in easily understood language
    gastrointestinal stromal tumour (GIST -, a cancer of the stomach and bowel) that has spread and cannot be surgically removed
    tumor del estroma gastrointestinal (GIST -, un cáncer del estómago y del intestino) que se ha diseminado y que no puede ser extirpado quirúrgicamente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10062427
    E.1.2Term Gastrointestinal stromal tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10051066
    E.1.2Term Gastrointestinal stromal tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 determine if an alternating regimen of imatinib and
    regorafenib has sufficient activity and safety to warrant further
    evaluation as a first line treatment for metastatic GIST.
    Determinar si una pauta alternante de imatinib y regorafenib posee suficiente actividad y seguridad para merecer un estudio posterior como tratamiento de primera línea para el TEGI metastásico.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults (over 18 yrs) with histologically confirmed GIST. In CD?117?negative cases DOG?1 must be positive or a KIT/PDGFRA mutation must be present.
    2. Unresectable, metastatic disease.
    3. No prior TKI for metastatic disease, with the exception of those patients who have had up to 21 days of uninterrupted treatment on 400mg daily of imatinib.
    4. Imatinib therapy given as an adjuvant treatment and completed at least 3 months prior to entry into this trial is permitted. Patients who have progression of GIST while on adjuvant therapy are not eligible for this trial.
    5. ECOG performance status 0?2
    6. Measurable disease by RECIST version 1.1. (Note: Participants with only peritoneal disease will be eligible only if they have lesions measurable in two dimensions and have at least 1 lesion
    which is ? 2 cm in size).
    7. Adequate bone marrow function (Haemoglobin ? 9.0g/dL, platelet count ? 100 x 109/L, and absolute neutrophil count ? 1.5 x 109/L).
    8. Adequate liver function (Serum total bilirubin ?1.5 x ULN, INR ? 1.5, and ALT, AST, ALP ?2.5 x ULN (? 5 x ULN for participants with liver metastases). Lipase level must be ? 1.5 x ULN.
    9. Adequate renal function (Creatinine clearance > 50ml/min) based on either the Cockcroft Gault formula, 24 hour urine or Glomerular Filtration Rate (GFR scan); and serum creatinine ? 1.5 x ULN.
    10. Tumour tissue available for central review.
    11. Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments.
    12. Study treatment both planned and able to start within 14 days of randomisation.
    13. Signed, written informed consent.
    1. Adultos (mayores de 18 años) con diagnóstico histológico de GIST. En los casos en los que la tinción inmunohistoquímica CD-117 sea negativa, DOG-1 debe ser positivo o debe estar presente una mutación de KIT / PDGFRA.
    2. Enfermedad metastásica irresecable.
    3. No tratamiento previo con TKI para la enfermedad metastásica, con la única excepción de aquellos pacientes que han recibido hasta 21 días de tratamiento con imatinib 400 mg diarios sin interrupciones.
    4. Se permite tratamiento adyuvante previo con imatinib siempre que se haya completado al menos 3 meses antes de la entrada en este ensayo. Los pacientes que presentan progresión de la enfermedad durante la terapia adyuvante, mientras que en no son elegibles para este ensayo.
    5. Estado funcional ECOG 0-2.
    6. Enfermedad medible por RECIST versión 1.1. (Nota: Los participantes con enfermedad peritoneal única serán elegibles solamente si poseen lesiones medibles en dos dimensiones y al menos una de ellas mide ? 2 cm de tamaño).
    7. Función de la médula ósea adecuada 7. (hemoglobina ? 9,0 g / dl, recuento de plaquetas ? 100 x 109 / L, y recuento absoluto de neutrófilos ? 1,5 x 109 / l).
    8. Función hepática adecuada (bilirrubina total ?1.5 x LSN, INR ? 1,5, ALT, AST y fosfatasa alcalina ?2.5 x LSN (? 5 x LSN para los participantes con metástasis hepáticas). El nivel de lipasa debe ser ? 1,5 x LSN.
    9. Función renal adecuada (aclaramiento de creatinina> 50 ml / min), basado en la fórmula de Cockcroft Gault, la orina de 24 horas o la tasa de filtración glomerular; y creatinina sérica ? 1,5 x LSN.
    10. Disponibilidad de tejido tumoral para su revisión central.
    11. Disponibilidad y capacidad de cumplir con todos los requisitos del estudio, incluyendo tiempo de tratamiento y / o naturaleza de las evaluaciones requeridas.
    12. Planificación y capacidad de iniciar el tratamiento de estudio dentro de los 14 días siguientes a la randomización.
    13. Consentimiento informado por escrito firmado.
    E.4Principal exclusion criteria
    1. Concurrent GI illness which may prevent absorption of imatinib or regorafenib ? please note that prior gastrectomy or bowel resection does not exclude patients from this study.
    2. Use of other investigational drugs within 4 weeks prior to enrolment.
    3. Known sensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    4. Participants receiving therapeutic doses of warfarin.
    5. Presence of brain metastases.
    6. The presence of PDGFR D842V mutation or other mutation known to cause imatinib resistance.
    7. Inability to swallow tablets.
    8. Arterial thrombotic or ischaemic events, such as cerebrovascular accident or pulmonary embolism within 6 months prior to randomisation; or major venous thrombotic events requiring use of an anticoagulant such as warfarin within 6 months prior to randomisation.
    9. Poorly controlled hypertension (systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
    10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or non healing wound, ulcer or fracture.
    11. Congestive cardiac failure (NYHA ? grade 2), unstable angina or new onset angina within the previous 3 months, or AMI within the previous 6 months. Cardiac arrhythmias requiring antiarrhythmic
    therapy (beta blockers or digoxin are permitted).
    12. Haemorrhage or bleeding event ? Grade 3 according to CTCAE v4.0 within 4 weeks prior to randomisation.
    13. Ongoing infection of > Grade 2 according to CTCAE v4.0.
    14. Active hepatitis B or C or HIV, or chronic hepatitis B or C requiring treatment with antiviral therapy. Testing for these is not mandatory unless clinically indicated.
    15. Interstitial lung disease with ongoing signs and symptoms.
    16. Persistent proteinuria of ? Grade 3 (>3.5g/24 hours) according to CTCAE v4.0
    17. Other significant medical or psychiatric condition judged by the investigator to interfere with protocol requirements.
    18. Use of biological response modifiers such as granulocyte colony stimulating factor (G?CSF), within 3 weeks prior to randomisation.
    19. Patients taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinovir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg carbamazepine, phenobarbitol, phenytoin, rifampicin, St John?s wort).
    20. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma?in?situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible.
    Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
    21. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a
    negative pregnancy test done within 7 days prior to registration. Women of childbearing potential and men must agree to use adequate contraception before entering the trial until at
    least 8 weeks after the last study drug administration.
    1. Enfermedad gastrointestinal concurrente que puede impedir la absorción de imatinib o regorafenib ? teniendo en cuenta que gastrectomía o resección intestinal previa no se considera un criterio de exclusión.
    2. El uso de otros fármacos en investigación dentro de 4 semanas antes de la inclusión.
    3. Sensibilidad conocida a cualquiera de los fármacos del estudio, o excipientes utilizados en su formulación.
    4. Tratamiento con dosis terapéuticas de warfarina.
    5. Presencia de metástasis cerebrales.
    6. La presencia de mutación D842V en PDGFR u otra mutación conocida que se asocie a resistencia a imatinib.
    7. Incapacidad para tragar comprimidos.
    8. Eventos arteriales trombóticos o isquémicos, como accidente cerebrovascular o embolia pulmonar, o grandes eventos trombóticos venosos dentro de los 6 meses previos, que requiera el uso de un anticoagulantes como la warfarina en los 6 meses anteriores a la randomización.
    9. Hipertensión arterial mal controlada (TA sistólica >140 mmHg o TA diastólica >90 mmHg a pesar de tratamiento médico).
    10. Procedimiento quirúrgico mayor, biopsia abierta o lesión traumática significativa dentro de los 28 días antes de la asignación al azar, o una herida que no cura, úlcera o fractura.
    11. Insuficiencia cardiaca congestiva (NYHA ? grado 2), angina inestable o angina de inicio en los últimos 3 meses, o IAM en los 6 meses anteriores. Las arritmias cardíacas que requieren antiarrítmico terapia (bloqueadores beta o digoxina se permiten).
    12. Hemorragia o evento hemorrágico ? Grado 3 de acuerdo con CTCAE v4.0 en las 4 semanas antes de larandomización.
    13. Infección activa de > Grado 2 según CTCAE v4.0.
    14. Hepatitis B activa o C o el VIH, o la hepatitis crónica B o C que requiere tratamiento con terapia antiviral. Las pruebas para estos no es obligatorio si no se indica clínicamente.
    15. Enfermedad pulmonar intersticial activa.
    16. Proteinuria persistente de ? Grado 3 (> 3,5 g / 24 horas) de acuerdo con CTCAE v4.0
    17. Otra condición médica o psiquiátrica significativa que, a criterio del investigador, pueda interferir con el protocolo.
    18. El uso de modificadores de la respuesta biológica tales como el factor estimulante de colonias de granulocitos (G-CSF), dentro de 3 semanas antes de la randomización.
    19. Tratamiento con inhibidores potentes de CYP3A4 del citocromo P (CYP) (por ejemplo, claritromicina, indinavir, itraconazol, ketoconazol, nefazodona, nelfinavir, posaconazol, ritonavir, saquinovir, telitromicina, voriconazol) o inductores potentes de CYP3A4 (por ejemplo, carbamazepina, fenobarbital, fenitoína, rifampicina, hierba de San Juan).
    20. Historia de otro tumor maligno dentro de los 5 años anteriores a la randomización. Los pacientes con antecedentes de carcinoma-in-situ, carcinoma de células basocelular de piel, carcinoma de piel de células escamosas, o carcinoma de células transicionales de la vejiga superficial tratado adecuadamente son elegibles.Los pacientes con antecedentes de otras neoplasias malignas son elegibles si han permanecido libres de la enfermedad durante al menos 5 años después del tratamiento primario definitivo.
    21. Embarazo, lactancia, o anticoncepción inadecuada. Las mujeres deben ser menopáusica post, infértil, o utilizar un medio fiable de anticoncepción. Las mujeres en edad fértil deben tener un prueba de embarazo negativa hecho dentro de 7 días antes de la inscripción. Las mujeres en edad fértil potencial y los hombres deben estar de acuerdo en utilizar un método anticonceptivo adecuado antes de entrar en el juicio hasta que al menos 8 semanas después de la administración del fármaco último estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression free survival will be assessed 8 weekly for the first 12 months of treatment and thereafter 12 weekly until 24 months of treatment.
    Supervivencia libre de progresión se evaluará cada 8 semanas durante los primeros 12 meses de tratamiento y posteriormente cada 12 semanas hasta los 24 meses de tratamiento.
    E.5.2Secondary end point(s)
    - Objective tumour response rate at 2 cycles after randomisation
    - Clinical benefit rate (SD + PR + CR) following 2 cycles of treatment
    - Complete response rate
    - Time to treatment failure
    - Safety/toxicity/tolerability
    - Overall survival
    - Tasa de respuesta tumoral objetiva después de 2 ciclos de tratamiento
    - Tasa de beneficio clínico (estabilización de la enfermedad [EE] + respuesta parcial [RP] + respuesta completa [RC]) después de 2 ciclos de tratamiento
    - Tasa de RC
    - Tiempo transcurrido hasta el fracaso terapéutico
    - Seguridad/toxicidad/tolerabilidad
    - Supervivencia general
    E.5.2.1Timepoint(s) of evaluation of this end point
    Objective tumour response rate and clinical benefit rate will assessed every 8 weeks until 16 weeks from randomization.
    Time to treatment failure, overall survival, complete response rate and safety will be assessed 8 weekly for the first 12 months of treatment and thereafter 12 weekly until 24 months of treatment.
    La tasa de respuesta tumoral objetiva y la de beneficio clínico se evaluarán cada 8 semanas hasta 16 semanas después de la aleatorización. El tiempo transcurrido hasta el fracaso terapéutico, la supervivencia general, la tasa de respuesta completa y la seguridad se evaluará cada 8 semanas durante los primeros 12 meses de tratamiento y posteriormente cada 12 semanas hasta los 24 meses de tratamiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Translational research
    Investigación translacional
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Australia
    Denmark
    Finland
    France
    Hong Kong
    Italy
    Netherlands
    Norway
    Singapore
    Slovakia
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Study End occurs when all of the following criteria have been satisfied:
    1. thirty days have elapsed after all patients have stopped Protocol treatment
    2. the trial is ready for the analysis of the primary endpoint as defined in the Protocol
    3. the database has been fully cleaned and frozen for this analysis.
    There are no study specific procedures foreseen after the end of trial but patients may continue visits to their treating physician in the frame of standard of care.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment after discontinuation of study treatment is at the discretion of the patient's clinician.
    In addition, Bayer will provide regorafenib to study participants for as long as they receive benefit from the treatment until local reimbursement after the completion of the study.
    El tratamiento a realizar tras la discontinuación del estudio en un determinado paciente queda a discreción del médico responsable del paciente. En adición, Bayer proveerá regorafenib a los participantes en el estudio por todo el tiempo que obtengan beneficio clínico del tratamiento, hasta el reembolso local tras la terminación del estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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