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    Summary
    EudraCT Number:2016-002349-50
    Sponsor's Protocol Code Number:M16TGA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-09
    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 number2016-002349-50
    A.3Full title of the trial
    Phase I/II study with galunisertib (LY2157299) combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer and an
    activated TGF-β signature
    MoTriColor: Estudio de fase I/II con galunisertib combinado con capecitabina en pacientes con cáncer colorrectal avanzado resistente a la quimioterapia y una firma de TGF-β activada.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II study with galunisertib combined with chemotherapy in patients with metastasized, resistent bowle cancer and an activated TGF-beta signature.
    Estudio de fase I/II con galunisertib combinado con capecitabina en pacientes con cáncer de colon metastásico resistente (a la quimioterapia) y una firma de TGF-β activada.
    A.4.1Sponsor's protocol code numberM16TGA
    A.5.4Other Identifiers
    Name:EORTCNumber:1615
    Name:MOTRICOLORNumber:CT1
    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 supportEli Lilly
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNKI-AVL
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportThe Directorate-General for Research and Innovation
    B.4.2CountryBelgium
    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 Schellens
    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 namecapecitabine
    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 INNCapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 500
    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 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 namegalunisertib
    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 INNGalunisertib
    D.3.9.1CAS number 700874-72-2
    D.3.9.3Other descriptive nameGALUNISERTIB
    D.3.9.4EV Substance CodeSUB126321
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number80 to 150
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: To determine the recommended phase 2 dose (RP2D) of galunisertib plus capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.

    Phase II: To determine the anti-tumor activity, as measured by response rate (RR) of galunisertib in combination with capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.
    Fase I: Determinar la dosis de fase II recomendada (DF2R2) de galunisertib más capecitabina en pacientes con CCR de firma TGF-β activada resistente a la quimioterapia.

    Fase II: Determinar la actividad antitumoral, medida por la tasa de respuesta (TR) de galunisertib en combinación con capecitabina en pacientes con CCR de firma TGF-β activada resistente a la quimioterapia.
    E.2.2Secondary objectives of the trial
    - To characterize the safety and tolerability of galunisertib in combination with chemotherapy regimens, as assessed by the incidence and severity of adverse events
    - To assess anti-tumor activity of galunisertib in combination with chemotherapy, as measured by duration of response, time to response and, progression free survival (phase II only) and overall survival (phase II only)
    - To determine the pharmacokinetic profile of galunisertib in combination with chemotherapy, as measured by plasma concentrations
    - To explore genetic determinants of response to galunisertib in combination with chemotherapy, as measured by baseline molecular status of potential predictive markers of tumor response
    - To explore the potential mechanism of resistance to galunisertib in combination with chemotherapy, as measured by gene alterations/expression profiles (e.g. baseline, relapse) in tumor tissue upon progression
    -Caracterizar la seguridad y tolerabilidad de pautas de galunisertib en combinación con quimioterapia, evaluado por la incidencia y la gravedad de acontecimientos adversos
    -Evaluar la actividad antitumoral de galunisertib en combinación con quimioterapia, medido por la duración de la respuesta, tiempo hasta la respuesta y supervivencia libre desin progresión (solo fase II) y supervivencia globaleneral (solo fase II)
    -Determinar el perfil farmacocinético de galunisertib en combinación con quimioterapia, medido por las concentraciones plasmáticas
    -Explorar los determinantes genéticos de respuesta a galunisertib en combinación con quimioterapia, medido por el estado molecular inicial de marcadores predictivos potenciales de respuesta tumoral
    -Explorar el mecanismo potencial de resistencia a galunisertib en combinación con quimioterapia, medido por perfiles de alteraciones/expresión genética (p. ej., inicio, recidiva) en tejido tumoral tras la progresión
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological or cytological proof of CRC;
    2. Disease progression or relapse upon first line of treatment (maximum lines of treatment is one for phase I and phase II of this study) for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed);
    3. Written documentation of activated TGF-β signature-like gene signature, as determined by the validated assay of Agendia;
    4. Age ≥ 18 years;
    5. Able and willing to give written informed consent;
    6. WHO performance status of ≤ 1;
    7. LVEF ≥ 55%;
    8. Able and willing to undergo blood sampling for PK and PD analysis;
    9. Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment
    10. Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;
    11. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part);
    12. Minimal acceptable safety laboratory values
    a. ANC of ≥ 1.5 x 109 /L
    b. Platelet count of ≥ 100 x 109 /L
    c. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT ≤ 5 x ULN in patients with liver metastases
    d. Renal function as defined by serum creatinine ≤1.5 x ULN
    e. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);
    13. Negative pregnancy test (urine or serum) for female patients with childbearing potential.
    1. Prueba histológica o citológica de CCR;
    2. Progresión de la enfermedad o recidiva acon la primera línea de tratamiento (el número máximo de líneas de tratamiento es una para la parte de la fase I y la fase II de este estudio) para CCR avanzado con fluoropirimidina con quimioterapia como agente único o en combinación (se permiten las combinaciones con oxaliplatino, irinotecán, bevacizumab y cetuximab/panitumumab);
    3. PruebaDocumentación por escrito de la firma TGF-β activada, según se determine en el ensayo validado de Agendia;
    4. Edad 18 años;
    5. Con capacidad y disposición para dar su consentimiento informado por escrito, el cual debe haber sido firmado antes del inicio de los procedimientos del ensayo;
    6. Estado funcional ≤1 según la OMS;
    7. FEVI ≥55 %;
    8. Con capacidad y disposición para someterse a una extracción de sangre para análisis FC y FD;
    9. Con capacidad y disposición para someterse a una biopsia tumoral antes del inicio del tratamiento, durante el mismo y al final de este;
    10. Esperanza de vida 3 meses, de modo que permita un seguimiento adecuado de la evaluación de la toxicidad y de la actividad antitumoral;
    11. Enfermedad evaluable de acuerdo con los criterios RECIST 1.1 (enfermedad medible para la a parte de la fase II; para la fase I la enfermedad evaluablemedible es suficiente para la parte de la fase I);
    12. Valores analíticos de seguridad mínimos aceptabless
    a. RAN de 1,5 x 109 /l
    b. Recuento plaquetario de 100 x 109/l
    c. Función hepática según se define por bilirrubina sérica 1,5 x LSN, ALAT y ASAT 3,0 x LSN o ALAT y ASAT <5 x LSN en pacientes con metástasis hepática
    d. Función renal según se define por una creatinina sérica 1,5 x LSN
    e. Aclaramiento de la creatinina 50 ml/min (según la fórmula Cockcroft-Gault o la fórmula de modificación de la dieta en la enfermedad renal [MDER]);
    13. Prueba de embarazo negativa (en orina o suero) para pacientes de sexo femenino en edad fértil.
    E.4Principal exclusion criteria
    1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment;
    2. Known or suspected dihydropirimidine dehydrogenase deficit (Mutant for DPD*2A genotype, 1236 GA genotype, 1679TG genotype and 2846A>T genotype);
    3. Symptomatic or untreated leptomeningeal disease;
    4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT (<21 days before start of treatment) completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids;
    5. History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart.
    6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral galunisertib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection);
    7. Woman 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. Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed;
    10. 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;
    11. Active infection requiring systemic antibiotics or uncontrolled infectious disease;
    12. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
    13. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study;
    14. Known hypersensitivity to one of the study drugs or excipients.
    1. Cualquier tratamiento con fármacos en investigación dentro de los 30 días previos a la recepción de la primera dosis del tratamiento en investigación;
    2. Deficiencia de la enzima dihidropirimidina deshidrogenasa conocida o sospechosa (mutadonte para el genotipo DPD*2A, el genotipo 1236 GA, el genotipo 1679TG y el genotipo 2846A>T);
    3. Enfermedad leptomeníngea sintomática o sin tratar;
    4. Metástasis cerebral sintomática. Los pacientes previamente tratados o sin tratar para estas afecciones que sean asintomáticos en ausencia de tratamiento con corticoesteroides pueden incluirsescribirse. La metástasis cerebral debe ser estable con verificación mediante imagen (p. ej., RM o TAC del cerebro completas en la selección, que demuestren la ausencia de evidencia actual de metástasis cerebral progresiva). No se permite a los pacientes recibir corticoesteroides o fármacos antiepilépticos inductores de enzimas;
    5. Antecedentes de enfermedad cardiaca, incluido infarto de miocardio dentro de los 6 meses previos a la entrada al estudio, angina de pecho inestable, insuficiencia cardiaca congestiva de clase III/IV según la clasificación de la Asociación del Corazón de Nueva York (New York Heart Association) o hipertensión no controlada, anomalías cardiacas graves, una predisposición para desarrollar aneurismas incluidos antecedentes familiares de aneurismas, síndrome de Marfan, válvula aórtica tricúspide o evidencia de datos en los vasos grandes del corazón.
    6. Alteración de la función gastrointestinal (GI) o enfermedad GI que pueda afectar de forma significativa a la absorción de galunisertib oral (p. ej., enfermedades ulcerosas, náuseas no controladas, vómitos, diarrea, síndrome de malabsorción, resección del intestino delgado);
    7. Mujer embarazada o en periodo de lactancia;
    8. Métodos anticonceptivos poco fiables. Tanto los hombres como las mujeres incluidosscritos en este ensayo deben aceptar utilizar un método anticonceptivo fiable durante el estudio (los métodos anticonceptivos adecuados son: preservativo, esterilización, otras medidas anticonceptivas de barrera, preferiblemente en combinación con preservativos);
    9. Radioterapia, inmunoterapia o quimioterapia dentro de las últimas 2 últimas semanas (y para fármacos en investigación 30 días) 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 habían recuperado totalmente de la cirugía anterior:
    11. Infección activa que requiere antibióticos sistémicos o enfermedad infecciosa sin controlar;
    12. Pacientes con antecedentes conocidos de hepatitis B o C, o pacientes con virus de la inmunodeficiencia humana conocido de tipo VIH-1 o VIH-2;
    13. 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 puede 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;
    14. Hipersensibilidad conocida a uno de los fármacos del estudio o sus excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: To determine the recommended phase 2 dose (RP2D) of galunisertib plus capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.

    Phase II: To determine the anti-tumor activity, as measured by response rate (RR) of galunisertib in combination with capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.
    Fase I: Determinar la dosis de fase II recomendada (DF2R2) de galunisertib más capecitabina en pacientes con CCR de firma TGF-β activada resistente a la quimioterapia.

    Fase II: Determinar la actividad antitumoral, medida por la tasa de respuesta (TR) de galunisertib en combinación con capecitabina en pacientes con CCR de firma TGF-β activada resistente a la quimioterapia.
    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 galunisertib in combination with chemotherapy regimens, as assessed by the incidence and severity of adverse events
    - To assess anti-tumor activity of galunisertib in combination with chemotherapy, as measured by duration of response, time to response and, progression free survival (phase II only) and overall survival (phase II only)
    - To determine the pharmacokinetic profile of galunisertib in combination with chemotherapy, as measured by plasma concentrations
    - To explore genetic determinants of response to galunisertib in combination with chemotherapy, as measured by baseline molecular status of potential predictive markers of tumor response
    - To explore the potential mechanism of resistance to galunisertib in combination with chemotherapy, as measured by gene alterations/expression profiles (e.g. baseline, relapse) in tumor tissue upon progression
    - Caracterizar la seguridad y tolerabilidad de pautas de galunisertib en combinación con quimioterapia, evaluado por la incidencia y la gravedad de acontecimientos adversos
    - Evaluar la actividad antitumoral de galunisertib en combinación con quimioterapia, medido por la duración de la respuesta, tiempo hasta la respuesta y supervivencia libre desin progresión (solo fase II) y supervivencia globaleneral (solo fase II)
    - Determinar el perfil farmacocinético de galunisertib en combinación con quimioterapia, medido por las concentraciones plasmáticas
    - Explorar los determinantes genéticos de respuesta a galunisertib en combinación con quimioterapia, medido por el estado molecular inicial de marcadores predictivos potenciales de respuesta tumoral
    - Explorar el mecanismo potencial de resistencia a galunisertib en combinación con quimioterapia, medido por perfiles de alteraciones/expresión genética (p. ej., inicio, 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharmacokinetic study
    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.8.3 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: 21
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 31
    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 Consortium
    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 Decision2018-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-08-05
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