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    Summary
    EudraCT Number:2015-004914-79
    Sponsor's Protocol Code Number:CA017-003
    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:2016-08-05
    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 number2015-004914-79
    A.3Full title of the trial
    A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1 Monoclonal Antibody) in Advanced Malignant Tumors
    Estudio fase 1/2a de BMS-986205 administrado en combinación con nivolumab (BMS-936558, anticuerpo monoclonal anti-PD-1) en tumores malignos avanzados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability, Pharmacokinetic/Pharmacodynamic and Preliminary Efficacy Study of BMS-986205 Administered in Combination With Nivolumab in Advanced Cancers
    Estudio de la seguridad, tolerabilidad, farmacocinética/farmacodinamia y eficacia preliminar de BMS-986205 administrado en combinación con nivolumab en cáncer avanzado
    A.4.1Sponsor's protocol code numberCA017-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02658890
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1173-1719
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number900 150 160
    B.5.6E-mailclinical.trials@bms.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 nameNivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection/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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameBMS936558
    D.3.9.4EV Substance CodeSUB32944
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameIDO-1 inhibitor
    D.3.2Product code BMS-986205
    D.3.4Pharmaceutical form Capsule
    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 INNBMS-986205
    D.3.9.2Current sponsor codeBMS-986205-04
    D.3.9.3Other descriptive nameBMS986205, BMS-986205
    D.3.9.4EV Substance CodeSUB179973
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 nameIDO-1 inhibitor
    D.3.2Product code BMS-986205
    D.3.4Pharmaceutical form Capsule
    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 INNBMS-986205
    D.3.9.2Current sponsor codeBMS-986205-04
    D.3.9.3Other descriptive nameBMS986205, BMS-986205
    D.3.9.4EV Substance CodeSUB179973
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Advanced Malignant Tumors
    Tumores malignos avanzados
    E.1.1.1Medical condition in easily understood language
    Advanced Malignant Tumors
    Tumores malignos avanzados
    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 10048683
    E.1.2Term Advanced 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
    The primary objective is to determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD)/maximum administered dose (MAD)/alternate dose of BMS-986205 administered as monotherapy and in combination with nivolumab in subjects with advanced malignant tumors.
    El objetivo principal es determinar la seguridad, tolerabilidad, toxicidades limitantes de la dosis (TLD) y dosis máxima tolerada (DMT)/dosis máxima administrada (DMA)/dosis alterna de BMS-986205 administrado en monoterapia y en combinación con nivolumab en sujetos con tumores malignos avanzados.
    E.2.2Secondary objectives of the trial
    - To characterize the pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab.
    - To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with - nivolumab.
    - To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205.
    - To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors.
    - Caracterizar la farmacocinética (FC) de BMS-986205 administrado en monoterapia y en combinación con nivolumab.
    - Caracterizar la actividad farmacodinámica de BMS-986205 administrado en monoterapia y en combinación con nivolumab.
    - Caracterizar la inmunogenicidad de nivolumab cuando se administra en combinación con BMS-986205.
    - Investigar la actividad antitumoral preliminar de BMS-986205 administrado en combinación con nivolumab en
    tumores malignos avanzados.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients must have been diagnosed with cancer and had at least 1 prior standard treatment
    •Must be able to swallow pills or capsules
    •Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
    - Los pacientes deben haber sido diagnosticados con cáncer y haber recibido anteriormente al menos 1 tratamiento estándar
    - Los pacientes deben ser capaces de tragar pastillas o cápsulas
    - Estado funcional ECOG (Eastern Cooperative Oncology Group) de 0 a 1.
    E.4Principal exclusion criteria
    •Any prior ongoing clinical study with Nivolumab with overall survival as an endpoint
    •Requirement for daily supplemental oxygen
    •Myocardial infarction or stroke/transient ischemic attack within the past 6 months
    •Uncontrolled angina within the past 3 months
    •History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus(HIV), or acquired immune deficiency syndrome(AIDS)
    - Cualquier ensayo clínico anterior en marcha con nivolumab con supervivencia global como un criterio de valoración
    - Necesidad de oxígeno suplementario diario
    - Infarto de miocardio o derrame cerebral/ataque isquémico transitorio en los 6 meses anteriores
    - Angina no controlada en los 3 meses anteriores
    - Historial de hepatitis crónica, hepatitis activa B o C, virus de la inmunodeficiencia humana (VIH) o síndrome de inmunodeficiencia adquirida (SIDA)
    E.5 End points
    E.5.1Primary end point(s)
    1/ Safety of BMS-986205 as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.

    2/ Safety of BMS-986205 plus nivolumab as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
    1/ La seguridad de BMS-986205 se medirá por la incidencia de acontecimientos adversos (AA), acontecimientos adversos graves (AAG), acontecimientos adversos que conduzcan a la suspensión, muertes y anomalías en las pruebas de laboratorio clínico.
    2/ La seguridad de BMS-986205 más nivolumab se medirá por la incidencia de acontecimientos adversos (AA), acontecimientos adversos graves (AAG), acontecimientos adversos que conduzcan a la suspensión, muertes y anomalías en las pruebas de laboratorio clínico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1/ and 2/ 100 days after the last dose of study therapy
    1/ y 2/ 100 días después de la última dosis del tratamiento del estudio
    E.5.2Secondary end point(s)
    1/ Maximum observed plasma concentration (Cmax) of BMS-986205
    2/ Time of maximum observed plasma concentration (Tmax) of BMS-986205
    3/ Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205
    4/ Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205
    5/ Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205
    6/ Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205
    7/ Observed plasma concentration at 24 hours (C24) of BMS-986205
    8/ Apparent terminal phase half-life (T-HALF) of BMS-986205
    9/ Apparent total body clearance (CLT/F) of BMS-986205
    10/ Apparent renal clearance (CLR/F) of BMS-986205
    11/ Volume of distribution of terminal phase (Vz/F) of BMS-986205
    12/ Apparent volume of distribution at steady state (Vss/F) of BMS-986205
    13/ Accumulation index (AI) of BMS-986205
    14/ Percent urinary recovery (%UR) of BMS-986205
    15/ Percent urinary recovery over 24 hours(%UR24) of BMS-986205
    16/ Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205
    17/ Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205
    18/ Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205
    19/ Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205
    20/ Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205
    21/ Objective response rate (ORR)
    22/ Progression free survival rate (PFSR)
    23/ Duration of response(DOR)
    1/ Concentración plasmática máxima observada (Cmax) de BMS-986205
    2/ Tiempo de la concentración plasmática máxima observada (Tmax) de BMS- 986205
    3/ Área bajo la curva de concentración-tiempo desde el momento cero extrapolada hasta el tiempo infinito [AUC(INF)] de BMS-986205
    4/ Área bajo la curva de concentración-tiempo desde el momento cero hasta el momento de la última concentración cuantificable [AUC(0-T)] de BMS-986205
    5/ Área bajo la curva concentración-tiempo en un intervalo de dosis [AUC(TAU)] de BMS-986205
    6/ Concentración plasmática observada en el valle al final del intervalo de administración (Cvalle) de BMS-986205
    7/ Concentración plasmática observada a las 24 horas (C24) de BMS-986205
    8/ Semivida de fase terminal aparente (T-MEDIO) de BMS-986205
    9/ Aclaramiento corporal total aparente (AclT/F) de BMS-986205
    10/ Aclaramiento renal aparente (AclR/F) de BMS-986205
    11/ Volumen de distribución de la fase terminal (Vz/F) de BMS-986205
    12/ Volumen de distribución aparente en el equilibrio (Veq/F) de BMS- 986205
    13/ Índice de acumulación (AI) de BMS-986205
    14/ Porcentaje de recuperación urinaria (%UR) de BMS-986205
    15/ Porcentaje de recuperación urinaria a lo largo de 24 horas (%UR24) de BMS-986205
    16/ Cociente de la Cmax del metabolito entre la Cmax del compuesto original, corregido por el peso molecular (MR_Cmax) de BMS-986205
    17/ Cociente del AUC(0-T) del metabolito entre el AUC(0-T) del compuesto original, corregido por el peso molecular (dosis única en el subestudio de farmacología clínica solo) [MR_AUC(0-T)] de BMS-986205
    18/ Cociente del AUC(TAU) del metabolito entre el AUC(TAU) del compuesto original, corregido por el peso molecular [MR_AUC(TAU)] de BMS-986205
    19/ Cociente del AUC(INF) del metabolito entre el AUC(INF) del compuesto original, corregido por el peso molecular (dosis única en el subestudio de farmacología clínica solo) [MR_AUC(INF)] de BMS-986205
    20/ Respuesta anticuerpo-antifármaco (ADA) a Nivolumab en combinación con BMS-986205
    21/ Tasa de respuesta objetiva (TRO)
    22/ Tasa de supervivencia libre de progresión (TSLP)
    23/ Duración de la respuesta (DdR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 3 years
    Aproximadamente 3 años
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    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 EEA23
    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 Yes
    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
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days5
    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: 173
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 288
    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)
    At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study drug. Study drug will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee or through another mechanism at the discretion of BMS.
    Cuando concluya el estudio los sujetos que continúen demostrando beneficio clínico, pueden ser elegibles para recibir el medicamento en estudio. El medicamento se suministraría a través de una extensión del estudio, un estudio de seguimiento requiriendo la autorización de las autoridades y del comité ético o a través de otro mecanismo según el criterio de BMS.
    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 Decision2016-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-10-15
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