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    The EU Clinical Trials Register currently displays   44238   clinical trials with a EudraCT protocol, of which   7337   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-005836-25
    Sponsor's Protocol Code Number:BAY73-4506/15967
    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:2012-03-20
    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 number2011-005836-25
    A.3Full title of the trial
    An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
    Estudio en fase IIIb, abierto, de regorafenib en pacientes con cáncer colorrectal (CCR) metastásico que han progresado a tratamientos convencionales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapy
    Regorafenib en pacientes con cáncer colorrectal (CCR) metastásico que han progresado a tratamientos convencionales
    A.4.1Sponsor's protocol code numberBAY73-4506/15967
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCPT Team / Ref: "EU CTR"/ Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 nameRegorafenib
    D.3.2Product code Bay 73-4506
    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.3.9.2Current sponsor codeBay 73-4506
    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
    Colorectal neoplasms
    neoplasias colorrectales
    E.1.1.1Medical condition in easily understood language
    Metastatic adenocarcinoma of the colon or rectum (metastatic CRC)
    Adenocarcinoma metastásico de colon o recto (CRC metastásico)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies

    to assess the safety of regorafenib
    -Administrar regorafenib a pacientes con diagnóstico de cáncer colorrectal metastásico que han fracasado a todos los tratamientos convencionales.

    -Evaluar la seguridad de regorafenib
    E.2.2Secondary objectives of the trial
    to assess progression free survival (PFS)
    Evaluar la supervivencia libre de progresión (SLP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects >= 18 years of age.
    - Life expectancy of at least 3 months
    - Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
    -Subjects with metastatic colorectal cancer (Stage IV).
    - Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan,bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
    -ECOG Performance Status of <= 1 (ECOG: Eastern Cooperative Oncology Group)
    -Adequate bone marrow, liver and renal function
    -Women of childbearing potential and men must agree to use adequate contraception
    -Pacientes de ambos sexos de >= 18 años de edad.
    -Esperanza de vida de al menos 3 meses.
    -Documentación histológica o citológica de adenocarcinoma en colon o recto. Se excluirá el resto de tipos histológicos.
    -Pacientes con cáncer colorrectal metastásico (estadio IV).
    -Progresión durante o en los 3 meses siguientes a la última administración de cualquiera de las terapias habituales aprobadas, que deberán incluir fluoropirimidina, oxaliplatino, irinotecán, bevacizumab y cetuximab/panitumumab (si existe KRAS WT) (WT: del inglés, "wild type"
    -Estado funcional de ECOG <= 1 (ECOG: Grupo oncológico cooperativo oriental)
    -Función renal, hepática y medular apropiada.
    -Las mujeres en edad fértil y los hombres deberán acceder a utilizar métodos anticonceptivos apropiados.
    E.4Principal exclusion criteria
    -Prior treatment with regorafenib.
    -Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication treatment
    -Pregnant or breast-feeding subjects.
    -Congestive heart failure >= New York Heart Association (NYHA) class 2.
    -Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).
    -Myocardial infarction less than 6 months before start of study drug.
    -Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    -Uncontrolled hypertension. (Systolic blood pressure>140 mmHg or diastolic pressure >90 mmHg despite optimal medical management).
    -Pleural effusion or ascites that causes respiratory compromise (>=CTCAE Grade 2 dyspnea). (CTCAE: common terminology criteria for adverse events)
    -Ongoing infection >Grade 2 CTCAE v. 4.0.
    -Known history of human immunodeficiency virus (HIV) infection.
    -Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
    -Subjects with seizure disorder requiring medication.
    -Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
    -Any hemorrhage or bleeding event >= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
    -Non-healing wound, ulcer, or bone fracture.
    -Renal failure requiring hemo-or peritoneal dialysis.
    -Dehydration CTCAE v. 4.0 Grade >=1.
    -Interstitial lung disease with ongoing signs and symptoms
    -Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours).
    -Any malabsorption condition.
    -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.
    -Concomitant participation or participation within the last 30 days in another clinical trial
    -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.
    -Tratamiento previo con regorafenib.
    -Pacientes sometidos a cirugía mayor o biopsia abierta o que han sufrido lesiones traumáticas significativas en los 28 días previos al inicio del tratamiento con la medicación del estudio.
    -Mujeres embarazadas o en periodo de lactancia.
    -Fallo cardiaco congestivo>=Clase II, según la New York Heart Association (NYHA).
    -Angina inestable (síntomas de angina en reposo) o angina de nueva aparición (iniciada en los últimos 3 meses).
    -Infarto de miocardio menos de 6 meses antes del inicio del tratamiento con la medicación del estudio.
    -Arritmias cardiacas que precisen de terapia con antiarrítmicos (se permiten betabloqueantes o digoxina).
    -Hipertensión no controlada. (presión arterial sistólica>140 mmHg o presión arterial diastólica>90 mmHg a pesar de recibir el debido tratamiento médico).
    -Efusión pleural o ascitis con resultado de dificultad respiratoria (>=disnea de grado 2 según CTCAE). (CTCAE: criterios terminológicos comunes para acontecimientos adversos).
    -Proceso infeccioso en curso>grado 2, según CTCAE versión 4.0.
    -Antecedentes conocidos de infección por VIH (virus de la inmunodeficiencia humana).
    -Hepatitis B o C activa, o hepatitis B o C crónica que precise tratamiento con una terapia antiviral.
    -Pacientes con trastorno convulsivo que precisen medicación.
    -Pacientes con evidencias o antecedentes de cualquier tipo de diátesis hemorrágica, independientemente del grado de gravedad.
    -Cualquier episodio hemorrágico o de sangrado >=grado 3 (según CTCAE) en las 4 semanas anteriores al inicio del tratamiento con la medicación del estudio.
    -Heridas que no cicatrizan, ulceraciones o fracturas de huesos.
    -Fallo renal que precise hemodiálisis o diálisis peritoneal.
    -Deshidratación de grado>= 1, según CTCAE versión 4.0.
    -Enfermedad pulmonar intersticial con signos y síntomas en curso.
    Proteinuria persistente de grado 3, según CTCAE (> 3,5 g/24 horas).
    -Problemas de malabsorción.
    -Toxicidad no resuelta superior a grado 1 (según CTCAE, versión 4.0) atribuida a cualquier terapia o procedimiento anterior, a excepción de alopecia, hipotiroidismo y neurotoxicidad inducida por oxaliplatino <= grado 2.
    -Participación concomitante o participación, en los últimos 30 días, en otro ensayo clínico.
    -Terapia anticáncer sistémica, incluida terapia citotóxica, terapia con inhibidores de la transducción de señales, inmunoterapia y terapia hormonal durante el presente ensayo o en las 4 semanas (o 6 semanas en el caso de la mitomicina C) previas a la administración de la medicación del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be safety
    Safety Analysis Set (SAF): the population for the safety analyses is the SAF. All subjects who received at least one dose of regorafenib belong to the SAF.
    -Descriptive summary tables will be presented on all safety parameters.
    -Subjects will be monitored for adverse events using the NCI-CTCAE version 4.0. (NCI: National Cancer Institute)
    -Treatment emergent adverse events and safety laboratory parameters will be summarized by NCI-CTCAE version 4.0 grade and by MedDRA terminology. A treatment-emergent AE is defined as any event arising or worsening after the start of study drug administration until 30 days after the last study medication.
    -AEs that caused subject withdrawal, dose reduction, or interruption will be summarized.
    -Patients who die during the study will be summarized and listed.
    -Patients with SAEs will be summarized and listed.
    -Adverse events leading to discontinuation will be summarized and listed.
    El criterio de valoración primario será la seguridad.
    Grupo de análisis de seguridad (GAS): la población para los análisis de seguridad es la población GAS. Todos los pacientes que hayan recibido al menos una dosis de regorafenib pertenecen a la población GAS.
    -Se presentarán tablas descriptivas con resúmenes de todos los parámetros de seguridad.
    -Para el control de acontecimientos adversos en los pacientes, se utilizarán los criterios de NCI-CTCAE, versión 4.0. (NCI: National Cancer Institute, Instituto Nacional del Cáncer estadounidense)
    -Los acontecimientos adversos derivados del tratamiento y los parámetros de laboratorio de seguridad se resumirán según el grado establecido por los criterios de NCI-CTCAE, versión 4.0, y la terminología de MedDRA. Un AA derivado del tratamiento es un acontecimiento que se produce o empeora tras haberse iniciado la administración de la medicación del estudio, y hasta los 30 días posteriores a dicha administración.
    -Se recogerán aquellos AA que hayan provocado la retirada del paciente, la reducción de la dosis o la interrupción del tratamiento.
    -Se recogerán y enumerarán los pacientes que hayan fallecido durante el estudio.
    -Se recogerán y enumerarán los pacientes con AAG.
    -Se recogerán y enumerarán los AA que del lugar a la suspensión del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last patient last visist date (no event-driven primary completion date)
    Última visita del último paciente
    E.5.2Secondary end point(s)
    PFS is the only efficacy variable to be analyzed in this study.
    The population for the efficacy analysis is the FAS. All subjects assigned to treatment belong to the FAS.
    -The Kaplan-Meier curve for PFS and the
    Kaplan-Meier estimate of median time to PFS with its confidence interval (CI)
    -PFS proportions at 3, 6, 9, 12, etc months with CIs
    La SLP será la única variable de eficacia a analizar en este estudio.
    la población para los análisis de eficacia es la población GCA. Todos los pacientes asignados al tratamiento pertenecen a la población GCA.
    Se presentará la curva de Kaplan-Meier de SLP y la estimación de Kaplan-Meier del tiempo estimado hasta la progresión con su intervalo de confianza (IC), así como las proporciones de SLP a 3, 6, 9, 12 [etc.] meses con IC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last patient last visist date ( no event-driven primary completion date)
    Última visita del último paciente
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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
    Austria
    Belgium
    Canada
    Czech Republic
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    United Kingdom
    United States
    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
    According to the European Union (EU) Clinical Trial Directive for each participating European Union (EU) country the end of the study will be reached when the last visit of the last subject for all centers in the respective country has occurred.

    Primary Completion is the same as LPLV, no early end point
    En cada país participante de la Unión Europea (UE), el final del estudio con arreglo a la Directiva de ensayos clínicos de la UE se alcanzará cuando se produzca la última visita al último paciente en todos los centros del país en cuestión.
    La fecha de conclusión primaria del estudio es la misma que la de la última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 1650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1350
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1920
    F.4.2.2In the whole clinical trial 3000
    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)
    N/A
    N/A
    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 Decision2012-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-30
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