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    Summary
    EudraCT Number:2016-000640-34
    Sponsor's Protocol Code Number:TTD-16-01
    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:2016-06-09
    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 number2016-000640-34
    A.3Full title of the trial
    A randomized phase 2 study comparing different dose-approaches of induction treatment (first cycle) of regorafenib in metastatic colorectal cancer (mCRC) patients
    Estudio aleatorizado fase 2 de comparación de diferentes dosis-pautas de tratamiento de inducción (primer ciclo) de regorafenib en pacientes con cáncer colorrectal metastasico (mCRC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized phase 2 study comparing different dose-approaches of induction treatment (first cycle) of regorafenib in metastatic colorectal cancer (mCRC) patients
    Estudio aleatorizado fase 2 de comparación de diferentes dosis-pautas de tratamiento de inducción (primer ciclo) de regorafenib en pacientes con cáncer colorrectal metastasico (mCRC).
    A.3.2Name or abbreviated title of the trial where available
    RE-ARRANGE
    RE-ARRANGE
    A.4.1Sponsor's protocol code numberTTD-16-01
    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 de Tratamiento de los Tumores Digestivos (TTD)
    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 supportTTD
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportBAYER
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrupo de Tratamiento de los Tumores Digestivos (TTD)
    B.5.2Functional name of contact pointInmaculada Ruiz de Mena
    B.5.3 Address:
    B.5.3.1Street AddressTéllez 30. First floor, office 4.2./4.3
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491378 82 75
    B.5.5Fax number+3491378 82 76
    B.5.6E-mailttd@ttdgroup.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 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.3.4Pharmaceutical form Film-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 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
    metastatic colorectal cancer
    Cancer colorectal metastásico
    E.1.1.1Medical condition in easily understood language
    Cancer colorectal metastásico
    Cancer colorectal metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    To evaluate the safety and tolerability of different dose-escalation approaches of regorafenib in mCRC patients.
    Evaluar la seguridad y la tolerabilidad de diferentes estrategias de aumento progresivo de la dosis de regorafenib en pacientes con mCRC.
    E.2.2Secondary objectives of the trial
    Percentage of total administrated dose over the planned dose accomplished in each arm
    Dose intensity during the whole treatment
    Dose intensity during first two cycles
    Disease control rate (DCR)
    Progression-free survival (PFS)
    Time to treatment failure (TTF)
    Overall survival (OS)
    Porcentaje de dosis total administrada respecto a la dosis prevista conseguido en cada grupo.
    Intensidad de dosis durante todo el tratamiento
    Intensidad de dosis durante los dos primeros ciclos
    Tasa de control de la enfermedad (TCE)
    Supervivencia sin progresión (SSP)
    Tiempo hasta fracaso del tratamiento (TFT)
    Supervivencia global (SG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent (IC) obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.
    2. Male or female subjects 18 years of age.
    3. Life expectancy of at least 3 months.
    4. Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
    5. Measurable metastatic stage IV disease with at least 1 measurable metastatic lesion following RECIST criteria v 1.1 and be documented by radiological evaluation.
    6. Subjects with metastatic colorectal cancer (Stage IV).
    7. Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF and an anti-EGFR (if RAS WT)
    8. Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
    9. Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible. Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study
    10. ECOG Performance Status of 0 or 1(within 14 days prior to the initiation of study treatment)
    11. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
    a. Total bilirubin ?1.5 x the upper limit of normal (ULN).
    b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? 2.5 x ULN (5 x ULN for subjects with liver involvement of their cancer).
    c. Alkaline phosphatase limit ? 2.5 x ULN (5 x ULN for subjects with liver and/or bone involvement of their cancer).
    d. Lipase ? 1.5 x the ULN.
    e. Serum creatinine 1.5 x the ULN or ? 30 mL/min as calculated using the Cockcroft-Gault equation.
    f. Platelet count >100000/mm3, hemoglobin >9 g/dL, absolute neutrophil count (ANC) >1500/mm3.
    g. International normalized ratio (INR)/ Partial thromboplastin time (PTT) 1.5 x ULN. (Subjects who are therapeutically treated with an agent such as
    warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close
    monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local
    standard.
    h. Blood transfusion to meet the inclusion criteria will not be allowed.
    12. Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care.
    Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment.
    1. Consentimiento informado (CI) firmado antes de los procedimientos específicos del estudio. Los pacientes deberán ser capaces de entender y estar dispuestos a firmar un consentimiento informado por escrito.
    2. Hombres o mujeres mayores de 18 años.
    3. Esperanza de vida mínima de 3 meses.
    4. Documentación histológica o citológica de adenocarcinoma de colon o recto. Se excluyen todos los demás tipos histológicos.
    5. Enfermedad metastásica medible en estadio IV, con como mínimo una lesión metastásica medible según los criterios RECIST v. 1.1 y documentada por evaluación radiológica.
    6. Pacientes con cáncer colorrectal metastásico (estadio IV).
    7. Progresión durante o en los 3 meses siguientes a la última administración de tratamientos de referencia aprobados, que deben incluir fluoropirimidina, oxaliplatino, irinotecán, un anti-VEGF y un anti-EGFR (si RAS WT).
    8. Los pacientes tratados con oxaliplatino adyuvante deberán haber progresado durante o en los 6 meses siguientes a la finalización del tratamiento adyuvante.
    9. Los pacientes que progresan más de 6 meses después de la finalización del tratamiento adyuvante con oxaliplatino deben volver a recibir tratamiento basado en oxaliplatino para ser aptos para participar en el estudio. Los pacientes que han dejado el tratamiento de referencia debido a una toxicidad inaceptable que justificó la suspensión del tratamiento y excluyó el retratamiento con el mismo fármaco antes de la progresión de la enfermedad también podrán entrar en el estudio.
    10. Estado funcional ECOG de 0 o 1 (en los 14 días previos al inicio del tratamiento del estudio).
    11. Función de la médula ósea, el hígado y los riñones adecuada según la evaluación de los siguientes análisis de laboratorio:
    a. Bilirrubina total ? 1,5 veces el límite superior de normalidad (LSN)
    b. Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ? 2,5 x LSN (5 x LSN para pacientes con afectación hepática del cáncer).
    c. Límite de fosfatasa alcalina ? 2,5 x LSN (5 x LSN para pacientes con afectación hepática u ósea del cáncer).
    d. Lipasa ? 1,5 x LSN
    e. Creatinina sérica 1,5 x LSN o ? 30 ml/min calculada según la ecuación de Cockcroft-Gault.
    f. Recuento de plaquetas > 100.000/mm3, hemoglobina > 9 g/dl, recuento absoluto de neutrófilos (RAN) > 1.500/mm3
    g. Cociente internacional normalizado (INR)/tiempo de tromboplastina parcial (TTP) 1,5 x LSN. (Los pacientes que estén recibiendo tratamiento con un fármaco como warfarina o heparina podrán participar siempre que no existan indicios previos de anomalías subyacentes de los parámetros de coagulación). Se realizará un estrecho control con análisis semanales hasta que el INR/TTP sea estable según un resultado obtenido antes de la administración, conforme se defina en el procedimiento de referencia local.
    h. No se permitirá realizar transfusiones de sangre para cumplir los criterios de inclusión.
    12. Las mujeres en edad fértil y los hombres deberán aceptar el uso de métodos anticonceptivos adecuados desde antes de entrar en el programa hasta como mínimo 8 semanas después de la administración de la última dosis del fármaco del estudio. El investigador o el personal designado deberá aconsejar al paciente para garantizar un control de la natalidad adecuado. En el estudio, los métodos anticonceptivos aceptables se definen como cualquier método (o combinación de métodos) recomendado desde el punto de vista médico, según las normas asistenciales habituales.
    Las mujeres en edad fértil deberán someterse a una prueba de embarazo un máximo de 7 días antes del inicio del tratamiento del estudio, y se deberá documentar un resultado negativo antes del inicio del tratamiento del estudio.
    E.4Principal exclusion criteria
    1. Prior treatment with regorafenib.
    2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
    3. Pregnant or breast-feeding subjects:
    4. Congestive heart failure ? New York Heart Association (NYHA) class 2.
    5. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).
    6. Myocardial infarction less than 6 months before start of study drug.
    7. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    8. Uncontrolled hypertension. (Systolic blood pressure > 140 mmHg or diastolic pressure >90 mmHg despite optimal medical management).
    9. Arterial or venous thromboembolism within 6 months prior to randomization.
    10. Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade 2 dyspnea).
    11. Ongoing infection > Grade 2 CTCAE v. 4.0.
    12. Known history of human immunodeficiency virus (HIV) infection.
    13. Known history of active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
    14. Subjects with seizure disorder requiring medication.
    15. History of organ allograft
    16. Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
    17. Any hemorrhage or bleeding event ? CTCAE Grade 3 within 4 weeks prior to the start of study medication.
    18. Non-healing wound, ulcer, or bone fracture.
    19. Renal failure requiring hemo-or peritoneal dialysis.
    20. Dehydration CTCAE v. 4.0 Grade ? 1.
    21. Substance abuse, medical, psychological or social conditions that may interfere with the subject?s participation in the study or evaluation of the study results.
    22. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    23. Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study.
    24. Interstitial lung disease with ongoing signs and symptoms
    25. Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours).
    26. Subjects unable to swallow oral medications.
    27. Any malabsorption condition.
    28. Unresolved toxicity higher than CTCAE (v. 4.0) > Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity > Grade 2.
    29. Subjects treated with strong CYP3A4 inhibitors or inducers (refer to appendix 8 and to section 6.3.8. Prohibited concomitant medication).
    30. Subjects receiving G-CSF within 3 weeks prior to signing the ICF
    31. Concomitant participation or participation within the last 30 days in another clinical trial
    32. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication.
    1. Tratamiento previo con regorafenib.
    2. Procedimiento quirúrgico mayor, biopsia abierta o lesión traumática significativa en los 28 días previos al inicio del fármaco del estudio.
    3. Pacientes embarazadas o en período de lactancia
    4. Insuficiencia cardíaca congestiva ? clase 2 de la New York Heart Association (NHYA)
    5. Angina inestable (síntomas de angina en reposo), angina de nueva aparición (que ha empezado en los 3 últimos meses).
    6. Infarto de miocardio menos de 6 meses antes del inicio del fármaco del estudio.
    7. Arritmias cardíacas que requieran tratamiento antiarrítmico (los betabloqueantes o la digoxina están permitidos)
    8. Hipertensión no controlada. (Presión arterial sistólica > 140 mmHg o presión arterial diastólica > 90 mmHg a pesar del tratamiento médico óptimo).
    9. Tromboembolismo arterial o venoso en los 6 meses previos a la aleatorización.
    10. Derrame pleural o ascitis que provoca una afectación respiratoria (disnea de grado 2 según los CTCAE).
    11. Infección en curso > grado 2 según los CTCAE v. 4.0.
    12. Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH).
    13. Antecedentes conocidos de hepatitis B o C activa, hepatitis crónica B o C que requiere tratamiento antiviral.
    14. Pacientes con trastornos convulsivos que requieran medicación.
    15. Antecedentes de aloinjerto de órganos.
    16. Pacientes con indicios o antecedentes de diátesis hemorrágica, con independencia de la intensidad.
    17. Cualquier hemorragia o episodio hemorrágico de grado ? 3 según los CTCAE en las 4 semanas previas al inicio del tratamiento del estudio.
    18. Herida tórpida, úlcera sin cicatrizar o fractura ósea no consolidada.
    19. Insuficiencia renal que requiere hemodiálisis o diálisis peritoneal.
    20. Deshidratación de grado ? 1 según los CTCAE v. 4.0.
    21. Consumo de sustancias psicoactivas y trastornos médicos, psicológicos o sociales que puedan interferir en la participación del paciente en el estudio o en la evaluación de los resultados del estudio.
    22. Hipersensibilidad conocida a cualquiera de los fármacos del estudio, clases de los fármacos del estudio o excipientes de la formulación.
    23. Cualquier enfermedad o afección médica que sea inestable o que pueda poner en peligro la seguridad del paciente y su cumplimiento terapéutico en el estudio.
    24. Neumopatía intersticial con signos y síntomas en curso.
    25. Proteinuria persistente de grado 3 (> 3,5 g/24 horas) según los CTCAE.
    26. Pacientes incapaces de tragar medicamentos orales.
    27. Cualquier trastorno de malabsorción.
    28. Toxicidad no resuelta de > grado 1 según los CTCAE (v. 4.0) atribuida a cualquier tratamiento/procedimiento previo, salvo alopecia, hipotiroidismo y neurotoxicidad inducida por oxaliplatino > grado 2.
    29. Sujetos tratados con inhibidores o inductores potentes de CYP3A4 (véase el apéndice 8 y el apartado 6.3.8. Medicación concomitante prohibida).
    30. Pacientes que reciben G-CSF en las 3 semanas previas a la firma del CI.
    31. Participación concomitante o participación en los últimos 30 días en otro estudio clínico.
    32. Tratamiento sistémico contra el cáncer que incluye tratamiento citotóxico, inhibidores de la transducción de señales, inmunoterapia y terapia hormonal durante este estudio o 4 semanas (o 6 semanas con mitomicina C) antes de empezar a recibir el medicamento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with G3/G4 treatment-related AEs in each arm according to CTCAE v4.03 criteria.
    Porcentaje de pacientes con AA relacionados con el tratamiento de grado 3/4 en cada grupo, según los criterios CTCAE v. 4.03.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment and follow-up period.
    Durante el tratamiento y periodo de seguimiento.
    E.5.2Secondary end point(s)
    Percentage of total administrated dose over the planned dose received in each arm
    Dose intensity during the whole treatment
    Percentage of dose reductions, delays and discontinuations in each arm
    Dose intensity during the first two cycles
    Disease control rate (DCR): % of patients with complete response (CR), partial response (PR) or stable disease (SD)
    Progression-free survival (PFS) defined as: time from randomization until the date of the first disease progression, observed radiologically, or death (whichever comes first). Subjects who have shown no progression while in the study and who did not die while in the study will be censored at the date of their last evaluable disease assessment.
    Time to treatment failure (TTF) defined as: time from randomization until the date the decision is made to end the treatment period, for any reason. For subjects who remain in the treatment period at the time of the analysis, time to treatment failure will be censored at the date of their last evaluable disease assessment.
    Overall survival (OS): time from randomization until the date of death due to any cause. Subjects who are lost to follow-up or who did not die by the end of the study will be censored at the last contact date.
    Porcentaje de dosis total administrada respecto a la dosis prevista recibido en cada grupo
    Intensidad de dosis durante todo el tratamiento
    Porcentaje de reducciones, retrasos y suspensiones de dosis en cada grupo
    Intensidad de dosis durante los dos primeros ciclos
    Tasa de control de la enfermedad (TCE): porcentaje de pacientes con respuesta completa (RC), respuesta parcial (RP) o enfermedad estable (EE)
    Supervivencia sin progresión (SSP) definida como: tiempo desde la aleatorización hasta la fecha de la primera progresión de enfermedad, observada radiológicamente, o muerte (lo que ocurra antes). Los pacientes que no hayan mostrado progresión y que no hayan fallecido durante el estudio serán censurados en la fecha de su última evaluación de la enfermedad.
    Tiempo hasta fracaso del tratamiento (TFT) definido como: tiempo desde la aleatorización hasta la fecha en que se toma la decisión de finalizar el período de tratamiento, por cualquier motivo. Para los pacientes que sigan en el período de tratamiento en el momento del análisis, el tiempo hasta el fracaso del tratamiento se censurará en la fecha de su última evaluación de la enfermedad.
    Supervivencia global (SG): tiempo desde la aleatorización hasta la fecha de la muerte por cualquier causa. Los pacientes a quienes se les pierda el seguimiento o que no habían fallecido al final del estudio se censurarán en la fecha del último contacto.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment and follow-up period.
    Durante el tratamiento y periodo de seguimiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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.8.2.4Number of treatment arms in the trial3
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    When patient ends the follow-up period attending to the last follow-up visit. It is anticipated a follow-up period of 1 year after the date of last patient inclusion in the study.
    El ensayo se dará por finalizado cuando cada paciente reclutado haya concluido el periodo de seguimiento acudiendo a la última visita de seguimiento .
    Está previsto un periodo de seguimiento de un año tras la inclusión del ultimo paciente en el studio.
    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
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state156
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 295
    F.4.2.2In the whole clinical trial 295
    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 Decision2016-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-24
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