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    Summary
    EudraCT Number:2016-001657-41
    Sponsor's Protocol Code Number:M15-531
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-001657-41
    A.3Full title of the trial
    A Phase 1b Dose Escalation Study Evaluating the Safety and
    Pharmacokinetics of Venetoclax in Combination with Azacitidine in
    Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes
    (MDS)
    Sperimentazione di Fase 1b di Incremento della Dose per valutare la sicurezza e la farmacocinetica di Venetoclax in combinazione con Azacitidina in soggetti con Sindromi Mielodisplastiche (MDS) ad alto rischio e naive rispetto al trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating Venetoclax with Azacitidine in Subjects with Previously
    Untreated Higher-Risk Myelodysplastic Syndromes (MDS)
    Sperimentazione per valutare Venetoclax in combinazione con Azacitidina rispetto ad Azacitidina in monoterapia in soggetti con Sindromi Mielodisplastiche (MDS) ad alto rischio.
    A.3.2Name or abbreviated title of the trial where available
    n/a
    n/a
    A.4.1Sponsor's protocol code numberM15-531
    A.5.4Other Identifiers
    Name:n/aNumber:M15-531
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbbvie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628561090
    B.5.5Fax number00441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameVenetoclax
    D.3.2Product code [ABT-199 (GDC-0199)]
    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 INNVenetoclax
    D.3.9.2Current sponsor codeABT-199
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 nameVenetoclax
    D.3.2Product code [ABT-199 (GDC-0199)]
    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 INNVenetoclax
    D.3.9.2Current sponsor codeABT-199
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 nameVenetoclax
    D.3.2Product code [ABT-199 (GDC-0199)]
    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 INNVenetoclax
    D.3.9.2Current sponsor codeABT-199
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
    Sindromi Mielodisplastiche (MDS) ad alto rischio trattate in prima linea (treatment naive)
    E.1.1.1Medical condition in easily understood language
    Cancer of the blood and bone marrows
    Cancro del sangue e del midollo osseo
    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 LLT
    E.1.2Classification code 10028532
    E.1.2Term Myelodysplasia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are to:
    • Assess the safety profile and pharmacokinetics (PK) of venetoclax in
    combination with azacitidine
    • Determine the recommended phase 2 dose (RPTD) and dosing
    schedule of venetoclax in combination with azacitidine
    Gli obiettivi primari della sperimentazione intendono:
    • Valutare il profilo di sicurezza e la farmacocinetica (PK) di Venetoclax in combinazione con Azacitidina.
    • Determinare la dose raccomandata di Fase 2 (recommended phase 2 dose, RPTD) e lo schema posologico di Venetoclax in combinazione con Azacitidina.
    • Determinare il tasso di risposta globale per Venetoclax in combinazione con Azacitidina e per Azacitidina in monoterapia.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess preliminary efficacy
    data on:
    • Overall response rate (ORR = sum of the rate of CR [complete
    remission] + PR [partial remission])
    • Rate of CR
    • Rate of hematologic improvement (HI; erythroid/platelet/neutrophil
    responses)
    • Rate of red blood cell (RBC) transfusion independence
    • Rate of platelet (PLT) transfusion independence
    • Rate of complete cytogenetic response
    • Rate of bone marrow blast response
    • Time to transformation to acute myelogenous leukemia (AML)
    • Duration of response (DOR)
    • Overall survival (OS)
    • Progression-free survival (PFS)
    • Time to next MDS treatment (TTNT)
    • Event-free survival (EFS)
    Gli obiettivi secondari della sperimentazione sono:
    . •Il tasso di risposta globale (ORR = somma dei tassi di remissione completa [complete remission, CR] + remissione parziale [Partial remission, PR])
    • Tasso di remissione completa (CR)
    • Tasso di miglioramento dei parametri ematologici (hematologic improvement, HI; risposta eritroide/piastrinica/dei neutrofili)
    • Tasso di indipendenza dalle trasfusioni di globuli rossi (RBC)
    • Tasso di indipendenza dalle trasfusioni di piastrine (PLT)
    • Tasso di risposta citogenetica completa
    • Tasso di risposta dei blasti a livello del midollo osseo
    • Tempo alla trasformazione in leucemia mieloide acuta (AML)
    • Ulteriori endpoint secondari (durata della risposta [duration of response, DOR], sopravvivenza [overall survival, OS], tempo libero da progressione [progression free survival, PFS], tempo al successivo trattamento anti-MDS [time to next anti-MDS treatment, TTNT], tempo libero da eventi [event-free survival, EFS]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must voluntarily sign and date an informed consent, approved
    by an Independent Ethics Committee (IEC)/Institutional Review Board
    (IRB), prior to the initiation of any screening or study specific
    procedures.
    2. Subject must be = 18 years of age.
    3. Subject must have documented diagnosis of previously untreated de
    novo MDS with:
    ¿ International Prognostic Scoring System (IPSS) risk categories Int-2
    or High (IPSS overall score = 1.5) and
    ¿ Presence of = 5% and < 20% bone marrow blasts per bone marrow
    biopsy/aspirate at screening
    4. Subject must have an Eastern Cooperative Oncology Group (ECOG)
    performance score of = 2.
    5. Subject is not a candidate to undergo intensive chemotherapy or
    allogeneic hematopoietic stem cell transplantation (HSCT).
    1.Il soggetto deve volontariamente firmare e datare un modulo di consenso informato approvato dal Comitato Etico (CE), prima che venga eseguita qualsiasi procedura per lo screening o specifica per la sperimentazione.
    2. Soggetto di età = 18 anni.
    3. Soggetto con diagnosi documentata di MDS de novo e mai trattato in precedenza, con:
    • Categoria di rischio IPSS (International Prognostic Scoring System) Int-2 o Alto (punteggio IPSS globale = 1,5) e
    • Presenza di blasti nel midollo osseo = 5% e < 20% alla biopsia osteomidollare/agoaspirato midollare eseguito al momento dello screening
    4. Soggetto con punteggio ECOG (Eastern Cooperative Oncology Group) = 2.
    5. Soggetto che non è idoneo a ricevere chemioterapia intensiva oppure trapianto allogenico di cellule staminali emopoietiche (HSCT).
    E.4Principal exclusion criteria
    1. Subject has received prior therapy for MDS.
    2. Subject has received prior therapy with a BH3 mimetic.
    3. Subject has received allogeneic HSCT or solid organ transplantation .
    4. Subject has received a live attenuated vaccine within 4 weeks prior to
    the first dose of study drug.
    1.Soggetto che ha ricevuto un pregresso trattamento per MDS
    2. Soggetto che ha ricevuto terapia pregressa con un BH3-mimetico
    3. Soggetto che ha ricevuto trapianto allogenico di cellule staminali oppure di organo solido.
    4. Il soggetto ha ricevuto un vaccino vivo attenuato nelle 4 settimane precedenti la prima dose del farmaco di studio
    E.5 End points
    E.5.1Primary end point(s)
    • Dose Escalation: Safety profile and PK
    • Determine the recommended phase 2 dose (RPTD)
    • Incremento della dose: profilo di sicurezza e farmacocinetica
    • Dose raccomandata di Fase 2 (recommended phase 2 dose, RPTD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    For RPTD: Measured from Day 1 until Day 28 per dose level
    PK will be collected on C1D1, C1D4, C2D4, C3D4, C4D4, C6D4 and C8D4.
    Per RPTD: Misurazioni dal giorno 1 fino al giorno 28 per valutare il livello della dose farmacocinetica saranno raccolti al C1D1, C1D4, C2D4, C3D4, C4D4, C6D4 e C8D4.
    E.5.2Secondary end point(s)
    The overall response rate (ORR = sum of the rates of complete
    remission [CR] + marrow complete remission [mCR] + partial remission
    [PR])
    • Rate of CR
    •Rate of mCR
    • Rate of hematologic improvement (HI; erythroid/platelet/neutrophil
    responses)
    • Rate of red blood cell (RBC) transfusion independence
    • Rate of platelet (PLT) transfusion independence
    • Rate of cytogenetic response
    • Rate of bone marrow blast response
    • Time to transformation to acute myeloid leukemia (AML)
    • Duration of response (DOR)
    • Overall survival (OS)
    • Progression-free survival (PFS)
    • Time to next MDS treatment (TTNT)
    • Event-free survival (EFS)
    •Il tasso di risposta globale (ORR = somma dei tassi di remissione completa [complete remission, CR] + remissione completa del midollo [mCR] + parziale [Partial remission, PR])
    •Tasso di CR
    - Tasso di mCR
    • Tasso di miglioramento dei parametri ematologici (hematologic improvement, HI; risposta eritroide/piastrinica/dei neutrofili)
    • Tasso di indipendenza dalle trasfusioni di globuli rossi (RBC)
    • Tasso di indipendenza dalle trasfusioni di piastrine (PLT)
    • Tasso di risposta citogenetica
    • Tasso di risposta dei blasti a livello del midollo osseo
    • Tempo alla trasformazione in leucemia mieloide acuta (AML)
    • Durata della risposta [duration of response, DOR]
    • Sopravvivenza globale [overall survival, OS]
    • Sopravvivenza libera da progressione [progression free survival, PFS]
    • Tempo al successivo trattamento anti-MDS [time to next anti-MDS treatment, TTNT]
    • Sopravvivenza libera da eventi [event-free survival, EFS]
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR, CR, HI, RBC, PLT: Measured from Day 1 until lack of treatment
    benefit or unacceptable toxicity, death, exercise of investigator
    discretion or withdrawal of consent
    • Cytogenetic response: Measured from screening until evidence of MDS
    progression, occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent.
    • Time to transformation to acute myeloid leukemia (AML): Measured
    from the date of first dose of study drug to the date of documented AML
    transformation
    • DOR: Measured from the date of first response to the earliest
    documentation of PD
    • OS, TTNT, EFS: Measured from the first dose of study drug
    NOTE: Refer to protocol for complete timepoints
    • ORR, CR, HI, RBC, PLT: Misurati dal giorno 1 fino al termine di benefici dal trattamento o tossicità inaccettabile, morte, esercizio dell’opinione del medico sperimentatore o ritiro del consenso • Risposta citogenetica: Misurata dallo screening fino ad evidenza di progressione dell’MDS, tossicità inaccettabile, morte, esercizio dell’opinione del medico sperimentatore o ritiro del consenso • Tempo di trasformazione della Leucemia Mieloide Acuta (AML): Misurata dai risultati della prima somministrazione di farmaco sperimentale fino al verificarsi della trasformazione di AML documentata • DOR: Misurata dalla data della prima risposta fino alla prima PD documentata • OS, TTNT, EFS: : Misurata dalla prima somministrazione di farmaco sperimentale
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory analysis
    Exploratory analysis
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 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 EEA12
    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 Information not present in EudraCT
    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
    United States
    European Union
    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
    The end-of-study is defined as the date of the last subject's last visit or date of last follow-up contact, whichever is later.
    il termine della sperimentazione è definito come la data dell'ultima visita dell'ultimo soggetto o la data dell'ultimo contatto di follow-up se posteriore
    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 days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 80
    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)
    After subject withdrawal from study treatment, further treatment is per the discretion of the investigator based on the treatment options available and local regulations
    After subject withdrawal from study treatment, further treatment is per the discretion of the investigator based on the treatment options available and local regulations
    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 Decision2016-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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