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    Summary
    EudraCT Number:2011-000198-29
    Sponsor's Protocol Code Number:CD-ON-MEDI-573-1030
    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:2011-08-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-000198-29
    A.3Full title of the trial
    A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)
    Estudio de fase 1b/2 aleatorizado de MEDI-573 en combinación con un inhibidor de la aromatasa (IA) frente a un IA en monoterapia en mujeres con cáncer de mama metastásico (CMM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in women with advanced breast cancer treated with standard therapy with or without MEDI-573
    Un estudio en mujeres con cáncer de mama avanzado tratadas con la terapia estándar con o sin MEDI-573
    A.4.1Sponsor's protocol code numberCD-ON-MEDI-573-1030
    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 SponsorMedImmune, LLC
    B.1.3.4CountryUnited States
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailClinicaltrialenquiries@medimmune.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 nameMEDI-573
    D.3.2Product code MEDI-573
    D.3.4Pharmaceutical form Solution for 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 INNN/A
    D.3.9.1CAS number 1204390-13-5
    D.3.9.2Current sponsor codeMEDI-573
    D.3.9.3Other descriptive nameAZD4253, MABABXLONAZ2.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 Metastatic Breast Cancer (MBC)
    Cáncer de mama metastásico avanzado
    E.1.1.1Medical condition in easily understood language
    Advanced Metastatic Breast Cancer (MBC)
    Cáncer de mama metastásico avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10006202
    E.1.2Term Breast cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast 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
    The primary objective of the dose-evaluation phase of this study (Phase 1b) is to evaluate the safety and tolerability of two doses of MEDI-573 in combination with an AI in patients with HR+, HER2-negative MBC

    The primary objective of the randomization phase (Phase 2) of this study is to evaluate the PFS of subjects treated with MEDI-573 and AI versus treatment with AI alone.
    El objetivo principal de la fase de evaluación de la dosis (fase 1b) del estudio es evaluar la seguridad y la tolerabilidad de dos niveles de dosis de MEDI-573 en combinación con un IA en pacientes con CMM RH+ y HER2-negativo.
    El objetivo principal de la fase de aleatorización (fase 2) del estudio es evaluar la SSP de las pacientes con CMM RH+ y HER2-negativo tratadas con MEDI-573 más un IA en comparación con un IA en monoterapia.
    E.2.2Secondary objectives of the trial
    Six secondary objectives

    ? To describe the safety and tolerability of MEDI-573 when used in combination with an AI

    ? To evaluate the anti-tumor activity of MEDI-573 when used in combination with an AI versus treatment with an AI alone

    ? To evaluate overall survival (OS) in subjects treated with MEDI-573 when used in combination with an AI versus treatment with an AI alone

    ? To describe the pharmacokinetics (PK) of MEDI-573 when used in combination with an AI

    ? To determine the pharmacodynamics of MEDI-573 when used in combination with an AI on circulating levels of insulin-like growth factor I (IGF-I) and insulin-like growth factor II (IGF-II)

    ? To determine the immunogenicity (IM) of MEDI-573 when used in combination with an AI
    Seis objetivos secundarios
    * Describir la seguridad y la tolerabilidad de MEDI-573 cuando se utiliza en combinación con un IA.
    * Evaluar la actividad antitumoral de MEDI-573 más un IA en combinación con un IA en monoterapia.
    * Evaluar la SG en pacientes tratadas con MEDI-573 más un IA en combinación con un IA en monoterapia.
    * Describir la farmacocinética de MEDI-573 en combinación con un IA
    * Determinar la farmacodinamia de MEDI-573 en combinación con un IA sobre las concentraciones de IGF-I e IGF-II circulantes.
    * Determinar la IM de MEDI-573 en combinación con un IA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following criteria:
    Female gender and age ? 18 years at time of study entry
    Women must be postmenopausal
    Written informed consent and any locally-required authorization
    Have histologically-confirmed metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
    Life expectancy of ? 6 months
    Subjects must have adequate organ and marrow function
    Suitable candidate for AI, including the ability to swallow and absorb oral agents
    Los pacientes deberán cumplir los siguientes criterios:
    Sexo femenino y tener 18 años o más en el momento de la incorporación al estudio.
    Las mujeres deben ser posmenopáusicas
    Consentimiento informado por escrito y cualquier autorización exigida localmente
    Tener un CMM confirmado histológicamente que no es susceptible de curación mediante intervención quirúrgica o radioterapia
    Esperanza de vida de al menos 6 meses
    Buena función de los órganos y la médula ósea
    Ser candidata idónea al tratamiento con IA, incluida la capacidad de tragar y absorber medicamentos orales
    E.4Principal exclusion criteria
    Any of the following would exclude the subject from participation in the study:

    Concurrent enrollment in another clinical study testing an investigational agent or
    intervention for cancer treatment or prevention
    Subject directly involved with the conduct of the study or an immediate family
    member of any such individual
    Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or
    biologic therapy for advanced or metastatic disease (except Prior adjuvant therapy with an AI is allowed, provided treatment ended at least 1 year prior to the first dose of therapy; Prior treatment with tamoxifen is allowed, provided treatment ended at least; 1 week prior to the first dose of therapy; Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed)
    History of allergy or reaction attributed to compounds of chemical or biologic
    composition similar to those of MEDI-573 or AI
    Subject for whom endocrine therapy of breast cancer is not appropriate (ie,
    life-threatening or rapidly progressing metastatic disease)
    Subjects with extensive symptomatic visceral disease including hepatic
    involvement and pulmonary lymphangitic spread of tumor, or disease that is
    considered by the investigator to be rapidly progressing or life threatening (eg,
    subjects who are intended for chemotherapy)
    Known central nervous system metastases or leptomeningeal carcinomatosis
    Evidence of spinal cord compression
    Unresolved toxicities from prior therapy with the exception of alopecia that have not
    resolved to ? Grade 1 (by National Cancer Institute Common Terminology Criteria
    for Adverse Events [NCI CTCAE] version 4.0) at the time of starting study treatment
    Receipt of any investigational therapy within 30 days or 5 half-lives, whichever is
    longer, prior to receiving the first dose of study treatment
    Previous treatment with agents that target the IGF receptor
    Use of immunosuppressive medication other than steroids within 7 days before the
    first dose of MEDI-573
    History of another primary malignancy within 5 years prior to starting study treatment
    except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the
    cervix
    Poorly controlled diabetes mellitus as defined by investigator assessment and/or
    hemoglobin A1c (HbA1c) > 8% within 21 days prior to randomization
    History of cardiac disease including, but not limited to, congestive heart failure
    > Class II New York Heart Association (see Appendix 3), active coronary artery
    disease (eg, unstable angina pectoris), new onset angina pectoris, myocardial
    infarction within the past 6 months, ventricular arrhythmias requiring antiarrhythmic
    therapy, or uncontrolled hypertension within the last 6 months
    Current active hepatic or biliary disease (with exception of subjects with Gilbert?s
    syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease
    per investigator assessment)
    Known human immunodeficiency virus or hepatitis B or C virus infection (either
    active, previously treated or both)
    Uncontrolled intercurrent illness including, but not limited to, ongoing or active
    infection requiring parenteral antibiotics, or a psychiatric illness/social situations that
    would limit compliance with study requirement
    Any condition that, in the opinion of the investigator, would interfere with evaluation
    of the investigational product or interpretation of subject safety or study results
    Any condition that compromises the subject?s ability to give informed consent
    La presencia de cualquiera de los siguientes criterios excluiría al sujeto de participar en el estudio:
    Participación simultánea en cualquier otro estudio clínico para evaluar un fármaco en investigación o una intervención para el tratamiento o la prevención del cáncer
    La paciente o un familiar directo de la misma están directamente implicados en la ejecución del estudio
    Pacientes que han recibido con anterioridad quimioterapia, tratamiento hormonal, inmunoterapia o tratamiento biológico para la enfermedad avanzada o metastásica (excepto el tratamiento adyuvante previo con un IA se admite, finalizado al menos un año antes de la primera dosis de la medicación; el tratamiento previo con tamoxifeno se admite, finalizado al menos una semana antes de la primera dosis de la medicación; la quimioterapia neoadyuvante o adyuvante previa para el cáncer de mama se admite)
    Antecedentes de alergia o reacción atribuible a sustancias de composición química o biológica similar a la de MEDI-573 o el IA
    Pacientes en las que no está indicado el tratamiento hormonal para el cáncer de mama (por ejemplo, enfermedad metastásica potencialmente mortal o rápidamente progresiva)
    Pacientes con afectación visceral extensa y sintomática, como la afectación hepática y la diseminación pulmonar linfangítica del tumor, o enfermedad que en opinión del investigador sea rápidamente progresiva o potencialmente mortal (por ejemplo, pacientes a las que se ha propuesto quimioterapia)
    Metástasis en el sistema nervioso central o carcinomatosis leptomeníngea
    Signos de compresión de la médula espinal
    Toxicidad de un tratamiento previo, excepto alopecia, que no se haya resuelto a un grado 1 o menor (según los criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute [CTCAE del NCI], versión 4.0) el momento de iniciar el tratamiento del estudio
    Haber recibido cualquier tratamiento en investigación en los 30 días o cinco semividas, lo que suponga más tiempo, antes de la primera dosis del tratamiento del estudio
    Tratamiento previo con fármacos que actúan sobre el receptor del IGF
    Tratamiento con inmunodepresores excepto corticosteroides en los 7 días previos a la primera dosis de MEDI-573
    Antecedentes de otro tumor maligno primario en los 5 años anteriores al inicio del tratamiento del estudio, salvo el cáncer de piel distinto del melanoma y el carcinoma cervicouterino in situ
    Diabetes mellitus mal controlada según la valoración del investigador o con hemoglobina A1c (HbA1c) superior al 8 % en los 21 previos a la aleatorización
    Antecedentes de cardiopatía, por ejemplo, insuficiencia cardíaca congestiva de clase II de la New York Heart Association (véase el apéndice 3), arteriopatía coronaria activa (por ejemplo, angina de pecho inestable), angina de pecho de nueva aparición, infarto de miocardio en los 6 últimos meses
    Enfermedad hepática o biliar actualmente activa (salvo pacientes con síndrome de Gilbert, litiasis biliar asintomática, metástasis hepáticas o hepatopatía crónica estable según el investigador)
    Infección por el virus de la inmunodeficiencia humana o por el virus de la hepatitis B o C (activa, ya tratada o ambas)
    Enfermedad intercurrente no controlada, como una infección en curso o activa que requiere antibióticos por vía parenteral, o una enfermedad psiquiátrica o situación social que limite el cumplimiento de los requisitos del estudio
    Cualquier trastorno que, en opinión del investigador, pueda interferir en la evaluación del producto en investigación, en la interpretación de la seguridad de la paciente o en los resultados del estudio
    Cualquier trastorno que afecta a la capacidad de la paciente para dar el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the dose-evaluation phase is to assess the safety of MEDI-573 when used in combination with AI. Outcome measures include identification of a DLT and descriptions of AEs.

    The primary endpoint for the randomization phase is PFS, which provides a direct measure of the effect of MEDI-573 on antitumor activity when used in combination with AI.
    El criterio de valoración principal para la fase de dosis-evaluación es determinar la seguridad de MEDI-573 cuando se usa en combinación con la IA. Las medidas incluyen la identificación de la TLD y descripcion de los acontecimientos adversos.
    El criterio de valoración principal para la fase de aleatorización es SSP, que proporciona una medida directa de los efectos de MEDI-573 sobre la actividad antitumoral cuando se usa en combinación con la IA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the first cycle (3 weeks) subjects will be evaluated every 9 weeks for safety and for disease progression
    Después del primer ciclo (3 semanas) los sujetos serán evaluados cada 9 semanas para la seguridad y la progresión de la enfermedad
    E.5.2Secondary end point(s)
    Secondary end point for Safety and Tolerability of MEDI-573 in Phase 2: The safety endpoints include AEs, SAEs, and changes in clinical laboratory evaluations from baseline.

    Pharmacokinetic Endpoint: Individual MEDI-573 concentrations will be tabulated by dose cohort along with descriptive statistics.

    Pharmacodynamic Endpoints: Circulating IGF-I and IGF-II levels will be summarized by dose cohort and descriptive statistics will be used. The time course of circulating IGF will be graphed based on dose group. Exposure-response analysis will be conducted to explore the relationship between MEDI-573 exposure and circulating biomarkers (such as IGF-I and IGF-II).

    Immunogenicity of MEDI-573: Analysis of IM results will be assessed by summarizing the number and percentage of subjects who develop detectable anti-MEDI-573 antibodies for all subjects entered in Phase 1b and Phase 2 (Arm 1 and Arm 2). The ADA titer will be reported for samples confirmed positive for the presence of anti-MEDI-573 antibodies. The effect of ADA on PK, pharmacodynamics, and safety will be evaluated

    Secondary Efficacy Endpoints: The secondary endpoints for assessing antitumor activity include ORR, time to response, duration of response (DR), time to progression (TTP), and OS and change in tumor size. Response Evaluation Criteria in Solid Tumors v1.1 guidelines will be used to evaluate tumor response.
    El criterio de valoración secundario para la seguridad y tolerabilidad de MEDI-573 en la Fase 2: Los criterios de valoración de seguridad incluyen eventos adversos, eventos adversos graves, y los cambios en las pruebas de laboratorio respecto al momento basal.
    Criterios de valoración Farmacocinéticos: Se tabularán las concentraciones individuales de MEDI-573 por cohorte de dosis y se resumirán mediante estadísticos descriptivos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint(s) of evaluation for Safety and Tolerability of MEDI-573 in Phase 2: Multiple safety visits during the first cycle, then every 9 weeks until disease progression.

    Timepoints for evaluation for the Pharmacokinetic, Pharmacodynamic and Immunogenicity endpoints: Multiple timepoints during the first cycle, then every 9 weeks during treatment.

    Timepoints for evaluation for Efficacy endpoints: Subjects will be evaluated for tumor response or progression at regular 9-week intervals until progression of disease. After disease progression, subjects will be followed for overall survival every 12 weeks until death or until the end of the study.
    Los momentos determinados para la evaluación de la seguridad y tolerabilidad de MEDI-573 en la Fase 2: múltiples visitas de seguridad durante el primer ciclo, y luego cada 9 semanas hasta la progresión de la enfermedad.
    Los momentos determinados para la evaluación de los criterios de valoración farmacocinéticos, farmacodinámicos y Inmunogenicidad: Múltiples momentos determinados durante el primer ciclo, y luego cada 9 semanas durante el tratamiento.
    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 No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Belgium
    Canada
    France
    Germany
    Hungary
    Israel
    Italy
    Spain
    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
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 267
    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)
    No treatment or care is provided to subjects after participation in the trial is complete. Subjects will be followed for survival after discontinuation of study drug and/or disease progression for up to 36 months or until the end of the study
    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 Decision2011-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-28
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