Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44015   clinical trials with a EudraCT protocol, of which   7317   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002364-13
    Sponsor's Protocol Code Number:M16VIB
    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:2017-10-02
    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 number2016-002364-13
    A.3Full title of the trial
    MoTriColor: A phase II study of vinorelbine in advanced BRAF-like colon cancer
    Motricolor: un estudio en fase II de vinorelbina en cáncer de colon avanzado con una firma de expresión génica BRAF mutado like.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial with vinorelbine, a form of chemotherapy, in intestinal cancer with a BRAF-like signature
    Ensayo clínico con vinorelbina, un tipo de quimioterapia, en cáncer de colon con una firma génica tipo BRAF-like
    A.4.1Sponsor's protocol code numberM16VIB
    A.5.4Other Identifiers
    Name:EORTCNumber:1616
    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 SponsorNetherlands Cancer Institute- Antoni van Leeuwenhoek hospital (NKI-AVL)
    B.1.3.4CountryNetherlands
    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 supportHorizon 2020
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportEORTC
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportAntoni van Leeuwenhoek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNetherlands Cancer Institute
    B.5.2Functional name of contact pointJan Schelens
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.schellens@nki.nl
    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.2.1.2Country 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 namevinorelbine
    D.3.4Pharmaceutical form 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 INNVINORELBINE
    D.3.9.1CAS number 71486-22-1
    D.3.9.4EV Substance CodeSUB00069MIG
    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 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
    colon carcinoma
    cáncer de colon
    E.1.1.1Medical condition in easily understood language
    intestinal cancer
    cáncer intestinal
    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 determine the anti-tumor activity, as defined as doubling of progression free survival (PFS) of vinorelbine treatment in patients with BRAF-like colon cancer. This means that by vinorelbine treatment the rate of progression at 6 weeks drops to 25%.
    Determinar la actividad antitumoral, esperando duplicar la supervivencia libre de progresión (SLP) del tratamiento con vinorelbina en pacientes con cáncer de colon “BRAF-like”. Esto significa que mediante el tratamiento con vinorelbina, la tasa de progresión a las 6 semanas caería al 25%.
    E.2.2Secondary objectives of the trial
    • To characterize the safety and tolerability of vinorelbine, as assessed by the incidence and severity of adverse events.
    • To assess efficacy of vinorelbine, as measured by overall response rate, duration of response, time to response and overall survival (OS).
    • To explore determinants (gene alteration/expression) of response to vinorelbine, as measured by baseline molecular status (mutation/ expression) in tumor tissue of potential predictive markers of tumor response.
    • To explore the potential mechanism of resistance to vinorelbine, as measured by gene alterations/expression profiles (i.e. baseline, relapse) in tumor tissue upon progression.
    • Caracterizar la seguridad y la tolerabilidad de la vinorelbina, mediante la evaluación de la incidencia y la gravedad de los acontecimientos adversos.
    • Evaluar la actividad antitumoral de vinorelbina, medida por la tasa de respuesta tumoral, la duración de la respuesta, el tiempo hasta la respuesta y la supervivencia global (SG).
    • Explorar los factores determinantes (alteración/expresión génica) de la respuesta a vinorelbina, medida por el estado molecular inicial (mutación/expresión) en el tejido tumoral de posibles marcadores predictivos de la respuesta tumoral.
    • Explorar el mecanismo potencial de resistencia a vinorelbina, medido por los perfiles de las alteraciones/expresión génica (es decir, situación basal, recidiva) en tejido tumoral tras la progresión.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent (+ TR (translational research)) must be given according to ICH/GCP and national/local regulations
    2. Written documentation of BRAF-like signature CC, including BRAFm and BRAFwt, as determined by the validated assay of Agendia
    3. Age ≥ 18 years
    4. Histologically proven and measurable (RECIST criteria v.1.1) metastatic adenocarcinoma of the colon not in a previously irradiated area, treated with one or two lines of standard of care therapy, including BRAF inhibitors, for locally advanced disease and metastatic disease
    5. WHO performance status of 0-1
    6. Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
    7. Negative urine pregnancy test for female patients with childbearing potential
    1. Se debe obtener el consentimiento informado por escrito (+ IT [investigación traslacional]) conforme a las ICH/BPC y a las legislaciones nacionales/locales.
    2. Documentación por escrito del CC de la firma “BRAF-like”, incluidos BRAFm y BRAFwt, determinado por el análisis validado de Agendia
    3. Edad >18 años
    4. Adenocarcinoma metastásico de colon demostrado histológicamente y medible (criterios RECIST v.1.1) en un área previamente sin irradiar, tratado con una o dos líneas de tratamiento estándar, incluidos inhibidores de BRAF, para enfermedad localmente avanzada y enfermedad metastásica
    5. Estado funcional 0-1 según la escala WHO
    6. Capacidad y disposición para someterse a una extracción de sangre para análisis farmacodinámico (FD)
    7. Capacidad y disposición para someterse a una biopsia tumoral antes del inicio del tratamiento, durante este y a la finalización del mismo
    8. Esperanza de vida >3 meses, que permita un seguimiento adecuado de la evaluación de la toxicidad y la actividad antitumoral
    9. Valores analíticos de seguridad aceptables:
    a. RAN >1,5 x 109/l
    b. Recuento plaquetario >100 x 109/l
    c. Hemoglobina > 6,0 mM/l
    d. Función hepática definida por una bilirrubina sérica <1,5 x LSN, ALAT y ASAT <2,5 x LSN o ALAT y ASAT <5 x LSN en pacientes con metástasis hepática
    e. Función renal definida por una creatinina sérica <1,5 x LSN
    f. Aclaramiento de la creatinina >50 ml/min (mediante la fórmula de Cockcroft-Gault)
    10. Prueba de embarazo en orina negativa para pacientes de sexo femenino en edad fértil
    E.4Principal exclusion criteria
    1. Any treatment with investigational drugs, including BRAF inhibitors, within 28 days prior to receiving the first dose of investigational treatment
    2. Symptomatic or untreated leptomeningeal disease
    3. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy (for at least 4 weeks) are allowed to enroll. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids
    4. Impairment of gastrointestinal (GI) function or GI disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, any condition inducing malabsorption, small bowel resection)
    5. Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection
    6. Known allergy or any other adverse reaction to any of the drugs or to any related compound
    7. Women who are pregnant or breast feeding
    8. Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
    9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery
    10. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
    11. Patients with a known history of hepatitis B or C
    12. Known hypersensitivity to study drug or excipients
    1.Cualquier tratamiento con fármacos en investigación, incluidos inhibidores de BRAF, en el plazo de los 28 días previos a recibir la primera dosis del tratamiento en investigación
    2. Enfermedad leptomeníngea sintomática o sin tratar
    3. Metástasis cerebral sintomática. Los pacientes previamente tratados o sin tratar para estas afecciones que sean asintomáticos en ausencia de tratamiento con corticoesteroides y anticonvulsivos (durante al menos 4 semanas) pueden incluirse. La radioterapia para metástasis cerebral debe haberse completado al menos 6 semanas antes del inicio del tratamiento del estudio. La metástasis cerebral debe ser estable confirmado mediante imagen (p. ej., RM o TAC del cerebro completas en la selección, que demuestren la ausencia de evidencia actual de metástasis cerebral activa). No se permite a los pacientes recibir corticoesteroides o fármacos antiepilépticos inductores de enzimas
    4. Alteración de la función gastrointestinal (GI) o enfermedad GI (p. ej., enfermedades ulcerosas, náuseas no controladas, vómitos, diarrea, cualquier afección que induzca la malabsorción, resección del intestino delgado)
    5. Otra enfermedad concomitante no controlada, incluida infecciónintercurrente grave no controlada
    6. Alergia conocida o cualquier otra reacción adversa a cualquiera de los fármacos o a cualquiera de los compuestos relacionados
    7.Mujeres embarazadas o en periodo de lactancia
    8.Métodos anticonceptivos poco fiables. Tanto los hombres como las mujeres incluidos en este ensayo deben aceptar utilizar un método anticonceptivo fiable durante el estudio (los métodos anticonceptivos aceptados son: preservativo, esterilización, otras medidas anticonceptivas de barrera, preferiblemente en combinación con preservativos)
    9. Radioterapia, inmunoterapia o quimioterapia dentro de las últimas 4 semanas previas a recibir la primera dosis del tratamiento en investigación. Se permite la radiación paliativa (1x 8Gy)
    10.Pacientes que se han sometido a cirugía mayor dentro de las 2 semanas previas al inicio del fármaco del estudio o que no se hayan recuperado totalmente de la cirugía anterior
    11. Pacientes con enfermedad infecciosa no controlada o con virus de la inmunodeficiencia humana de tipo VIH-1 o VIH-2
    12. Pacientes con antecedentes conocidos de hepatitis B o C
    13. Pacientes con comorbilidades cardiacas (infarto de miocardio dentro de los 6 meses previos al inicio del estudio, clase ≥ III según la clasificación de la NYHA, insuficiencia cardiaca congestiva o angina de pecho inestable), hipertensión no controlada (presión arterial sistólica >150 mmHg y/o presión arterial diastólica >90 mmHg) o intervalo QT prolongado (>440 ms para hombres, >460 ms para mujeres)
    14. Otra afección médica o psiquiátrica grave, aguda o crónica o anomalía de laboratorio que pudiera aumentar el riesgo asociado a la participación en el estudio o a la administración del fármaco del estudio, o que pueda interferir con la interpretación de los resultados del estudio y que, a juicio del investigador, haría que el paciente no fuera apropiado para el estudio.
    15. Hipersensibilidad conocida al fármaco del estudio o sus excipientes
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate the safety and anti-tumor activity of vinorelbine in paitents with BRAF-like colon cancer, who are previously treated with maximally two lines of standard of care therapy for advanced disease. The study will be powered to demonstrate a doubling of progression free survival (PFS) of vinorelbine treatment compared with historic controls. This means that by vinorelbine treatment the rate of progression at 6 weeks drops to 25%
    Demostrar la seguridad y la actividad antitumoral de la vinorelbina en pacientes con cáncer de colon tipo BRAF-like, que han sido tratados con un máximo de dos líneas previas de tratamiento estándar para la enfermedad avanzada.
    El estudio tendrá potencia para demostrar una duplicación de la supervivencia libre de progresión (PFS) del tratamiento con vinorelbina en comparación con controles históricos.
    Esto significa que mediante el tratamiento con vinorelbina la tasa de progresión a las 6 semanas disminuye al 25%
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    Al final del ensayo
    E.5.2Secondary end point(s)
    • To characterize the safety and tolerability of vinorelbine, as assessed by the incidence and severity of adverse events.
    • To assess efficacy of vinorelbine, as measured by overall response rate, duration of response, time to response and overall survival (OS).
    • To explore determinants (gene alteration/expression) of response to vinorelbine, as measured by baseline molecular status (mutation/ expression) in tumor tissue of potential predictive markers of tumor response.
    • To explore the potential mechanism of resistance to vinorelbine, as measured by gene alterations/expression profiles (i.e. baseline, relapse) in tumor tissue upon progression.
    • Caracterizar la seguridad y tolerabilidad de la vinorelbina, evaluada por la incidencia y gravedad de los eventos adversos.
    • Evaluar la eficacia de la vinorelbina, medida mediante la tasa de respuesta global, la duración de la respuesta, el tiempo de respuesta y la supervivencia global (SG).
    • Explorar los factores determinantes (alteración/expresión génica) de la respuesta a vinorelbina, medida por el estado molecular inicial (mutación/expresión) en el tejido tumoral de posibles marcadores predictivos de la respuesta tumoral.
    • Explorar el mecanismo potencial de resistencia a vinorelbina, medido por los perfiles de las alteraciones/expresión génica (es decir, situación basal, recidiva) en tejido tumoral tras la progresión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the trial
    Al final del ensayo
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    LVLS
    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 months17
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 42
    F.4.2.2In the whole clinical trial 42
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Motricolor
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA