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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2011-005408-13
    Sponsor's Protocol Code Number:2689-CL-2004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-005408-13
    A.3Full title of the trial
    A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AC220 in adults with refractory/relapsed Acute Myeloid Leukaemia
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code number2689-CL-2004
    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 SponsorAmbit BioSciences Corporation
    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 supportAmbit BioSciences Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmbit BioSciences Corporation
    B.5.2Functional name of contact pointDoranne Frano
    B.5.3 Address:
    B.5.3.1Street Address11080 Roselle Street
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018583342108
    B.5.5Fax number0018583342192
    B.5.6E-maildfrano@ambitbio.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/622
    D.3 Description of the IMP
    D.3.1Product nameQuizartinib dihydrochloride
    D.3.2Product code AC220
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNQuizartinib dihydrochloride (USAN)
    D.3.9.1CAS number 1132827-21-4
    D.3.9.2Current sponsor codeAC220, AC0102201 2HCL, ASP2689 2HCL, IT01
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/622
    D.3 Description of the IMP
    D.3.1Product nameQuizartinib dihydrochloride
    D.3.2Product code AC220
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNQuizaritinib dihydrochloride (USAN)
    D.3.9.1CAS number 1132827-21-4
    D.3.9.2Current sponsor codeAC220, AC010220 2HCL, ASP2689 2HCL, IT 01
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number135
    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
    Acute Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    Cancer of the White Blood Cells
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    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 are to evaluate the rate of Grade 2 or higher QTcF prolongation and to
    evaluate the composite complete remission rate (CRc), defined as the confirmed rate of
    complete remission (CR) plus complete remission with incomplete platelet recovery (CRp) or
    incomplete hematological recovery (CRi) at different doses of AC220.
    E.2.2Secondary objectives of the trial
    The secondary objectives are the following for AC220:
     Characterize the pharmacokinetics (PK) of AC220 and the active metabolite AC886
     Evaluate the electrocardiogram (ECG) effects of AC220 in relation to plasma drug
    concentration
     Evaluate the CR rate, overall survival (OS), event-free survival (EFS), leukemia-free
    survival (LFS), and duration of remission
     Assess overall safety

    Exploratory objectives are the following for AC220:
     Evaluate the pharmacodynamic (PD) effect of AC220
     Evaluate the mechanism of acquired resistance to AC220
     Evaluate PK-PD relationships
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There will be an optional sub-study as described in Appendix 10, Final Protocol 19Dec 2011, page 90.
    The pharmacogenomic research that will be conducted in the future with acquired blood samples is exploratory. The objective of this research is to comprehensively analyze:
    • Genes of relevance to clinical response, pharmacokinetics, and toxicity/safety issues, to be identified in a precautionary/retrospective setting
    By analyzing differing genetic polymorphisms, it may be possible to predict genetic influence on an individual subject’s response to ASP2689 [AC220] in terms of efficacy and/or toxicity.
    E.3Principal inclusion criteria
    1. Subject has provided an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved signed Informed Consent and privacy disclosure as per national regulations (e.g., HIPAA Authorization for U.S. sites) prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is male or female ≥ 18 years of age.
    3. Subject has morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS) as defined by the World Health Organization (WHO) criteria, as determined by pathology review at the treating institution and has relapsed or is refractory after 1 second line (salvage) regimen or after HSCT (Appendix 8).
    4. Subject is positive for FLT3-ITD activating mutation in bone marrow or peripheral blood (>10% allelic ratio as determined by central lab).
    5. ECOG performance status of 0 to 2 (Table 4).
    6. In the absence of rapidly progressing disease clearly documented by the investigator, the interval from prior treatment to time of AC220 administration will be at least 2 weeks (14 days) for prior cytotoxic agents or at least 5 half-lives for prior noncytotoxic agents, including immunosuppressive therapy post HSCT.
    7. Persistent chronic clinically significant nonhematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
    8. Patients - both males and females - with reproductive potential are eligible if the following criteria is met:
     female subject is:
    - post-menopausal (defined as at least 2 years without menses) prior to Screening visit; or
    - surgically sterile (at leats 1 month) prior to Srceening visit; or
    - childbearing potential without contraception
     female subject of childbearing potential has negative pregnancy test at Screening visit and agrees to use contraception consisting of two forms of birth control (one of which must be a barrier method) throughout the study period
     male subject with partner(s) of childbearing potential must agree to use contraception consisting of two forms of birth control (one of which must be a barrier method) and agrees to no sperm donation throughout the study period
    9. Subject must have adequate renal, hepatic, and coagulation parameters as indicated by the following laboratory values:
     Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit of normal (ULN)
     Total bilirubin ≤ 1.5 x institutional ULN
     Serum creatinine ≤ 1.5 x institutional ULN and glomerular filtration rate (GFR) > 30mL/min (calculated by Cockcroft and Gault formula, Appendix 9).
    10. Subject is able to comply with study procedures and follow-up examinations.
    E.4Principal exclusion criteria
    1. Subject received previous treatment with AC220.
    2. Subject has a diagnosis of acute promyelocytic leukemia.
    3. Subject has a diagnosis of chronic myelogenous leukemia (CML) in blast crisis.
    4. Subject has AML or antecedent MDS secondary to prior chemotherapy.
    5. Subject has had HSCT and has either of the following:
     Is within 100 days of transplant
     Is still taking immunosuppressive drugs
     Has clinically significant graft-versus-host disease requiring treatment
     Has Grade > 1 persistent nonhematological toxicity related to the transplant.
    Donor lymphocyte infusion (DLI) is not permitted during the study or < 30 days prior to study entry.
    6. Subject has clinically active CNS leukemia. If CNS leukemia is controlled and subject is receiving intrathecal (IT) therapy at study entry, subjects may be considered eligible at the discretion of the Investigator and with agreement of the Sponsor. Subjects should continue to receive IT therapy as clinically indicated.
    7. Subject has received concurrent chemotherapy, immunotherapy, or radiotherapy within 14 days prior to the first dose of AC220, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
    8. Subject requires treatment with concomitant drugs that prolong QT/QTc interval or with strong inhibitors or inducers of cytochrome P450-isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care posttransplant or to prevent or treat infections and other such drugs that are considered
    absolutely essential for the care of the subject. (See Appendix 1)
    9. Subject requires treatment with anticoagulant therapy.
    10. Subject has a known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen.
    11. Subject had major surgery within 4 weeks prior to first dose of AC220.
    12. Subject has uncontrolled or significant cardiovascular disease,
    including
     A myocardial infarction within 12 months prior to the start of study drug;
     Uncontrolled angina within 6 months prior to the start of study drug;
     History of congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4, if a screening echocardiogram (ECHO) or Multiple Gate Acquisition Scan (MUGA) is performed either within 1 month prior to or during study screening and the result is a left ventricular ejection fraction (LVEF) that is ≥ 45% (or institutional lower limit of normal value); then this is not exclusionary
     Heart rate < 50 beats per minute at Screening ECG;
     Diagnosed or suspected congenital long QT syndrome;
     Known family history of congenital long QT syndrome;
     QTc interval calculated by Fridericia's correction factor (QTcF) at
    Screening and Day 1 (before AC220 dose) ≥ 450 ms. The QTcF will be derived from the average QTcF in triplicate;
     Any history of second or third degree heart block;
     Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg;
     Obligate need for a cardiac pacemaker or defibrillator;
     Complete left bundle branch block;
     Atrial fibrillation documented within 2 weeks prior to first dose of
    study drug; or
     History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (CTCAE Grade 3).
    13. Subject has a pre-existing disorder predisposing the subject to a serious or life-threatening infection (e.g. cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder or cytopenias not related to AML).
    14. Subject has an active uncontrolled acute or chronic systemic fungal, bacterial, viral or other infection.
    15. Subject has any of the following laboratory values:
     Serum potassium < 4.0 mmol/L despite supplementation, or > 5.5 mmol/L.
     Serum magnesium below the institutional normal limit despite supplementation, or > 3 mg/dL (1.23 mmol/L).
     Serum calcium >11.5 mg/dL (2.9 mmol/L) or ionized calcium >1.5 mmol/L.
    16. Subject is a female with a positive pregnancy test, pregnant, or breastfeeding.
    17. Subject has any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable is the rate of composite complete response (CRc).
    Definition of CRc:
     Composite Complete Remission Rate (CRc): Defined as the confirmed remission rate of all
    complete and incomplete CRs (i.e., CR + CRp + CRi).
     Complete Remission (CR): For subjects to be classified as being in CR, they must have bone marrow regenerating normal hematopoietic cells and achieve a morphologic leukemia-free state and must have an absolute neutrophil count (ANC) > 1x10e9/L and platelet count > 100 x 10e9/L, and normal marrow differential with < 5% blasts, and they
    will be red blood cell (RBC) and platelet transfusion independent (defined as 4 weeks without RBC transfusions and 1 weeks without platelet transfusion). There should be no evidence of extramedullary leukemia.
     Complete Remission with Incomplete Platelet Recovery (CRp): For subjects to be classified as being in CRp, they must achieve CR except for incomplete platelet recovery (< 100 x10e9/L).
     Complete Remission with Incomplete Hematologic Recovery (CRi): For subjects to be classified as being in CRi, they must achieve CR except for incomplete hematological recovery with residual neutropenia <1 x 10e9/L with or without complete platelet recovery.
    RBC and platelet transfusion independence is not required.
    Primary safety variable is the rate of Grade 2 or higher QTcF prolongation.
    Definition of QTcF prolongation, Grade ≥ 2 ECGs will be recorded in triplicate (3 separate 12-lead ECGs at least 5 minutes apart per time
    point) and the Fridericia’s correction of the QT interval (QTcF) will be calculated based on the average of all the ECGs obtained around that time point.
    QTcF grading will be done according to CTCAE v. 4.03, and the definition of greater than Grade 2 prolongation is QTcF ≥ 480 ms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    These end points will be evaluated at the end of the study
    E.5.2Secondary end point(s)
    Secondary safety variables are:
     Adverse Events (AEs)
     Serum chemistry, hematology, and urinalysis
     Vital sign measurements
     ECGs
     ECOG performance scores

    Secondary efficacy variables are:
     Complete remission (CR)
     Overall survival (OS)
     Event free survival (EFS)
     Leukemia free survival (LFS)
     Duration of remission

    Pharmacokinetics
     Subjects with sufficient PK samples on Cycle1 Day 1 and Cycle 1 Day 15, NCA will be
    performed for to obtain PK parameter estimates for AC220 and AC886 PK parameters
    including AUC24, Cmax, Ctrough and tmax
     Population PK of AC220 and its active metabolite (AC866)

    Pharmacogenetics
     FLT3-ITD status and allelic ratio will be measured.
     Mutations in the JM and TK domains of FLT3, FLT3-ITD and C-KIT sequences will be
    determined using bone marrow or whole blood samples.

    Exploratory Variables
    Inhibition of phosphorylation of FLT3 and STAT5 will be determined using whole blood
    samples.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These end points will be evaluated at the end of the study
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The pharmacogenomic assessment will be made. This is an optional sub-study. Appendix 10, Final protocol 19Dec2011, page 90.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    other dose of same drug
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    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
    The end of the trial will be the last visit of the last subject undergoing the trial (after long-term follow-up phase).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 64
    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 treatment discontinuation, subjects will be followed for 30 days for safety, after which the subjects will enter long-term follow up for collection of subsequent AML treatment, remission status, and survival (cause of death and date of death).
    Any other treatment or care will be discussed with the investigator.
    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 Decision2012-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-12
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