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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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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.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    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:2009-013093-41
    Sponsor's Protocol Code Number:AC220-002
    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:2010-03-17
    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 number2009-013093-41
    A.3Full title of the trial
    A PHASE 2 OPEN-LABEL, AC220 MONOTHERAPY EFFICACY (ACE) STUDY IN PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML) WITH AND WITHOUT FLT3-ITD ACTIVATING MUTATIONS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study is designed to determine the efficacy of AC22O in patients with Acute Myeloid Leukemia (AML) with and without FLT3-ITD activating mutations.

    AML is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells.
    A.4.1Sponsor's protocol code numberAC220-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00989261
    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 pointClinical Research and Development
    B.5.3 Address:
    B.5.3.1Street Address4215 Sorrento Valley Boulevard
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number1-858-334-2136
    B.5.5Fax number1-858-724-1845
    B.5.6E-mailACEstudy@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 nameAC220
    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, AC010220·2HCl, ASP2689•2HCl, IT01
    D.3.9.3Other descriptive nameN-[(5-tert-butyl)isoxazol-3-yl]({4-[7-(2-morpholin-4-ylethoxy)(4-hydroimidazo[2,1-b]benzothiazol-2-yl)]phenyl}amino)carboxamide dihydrochloride salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200mg
    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 nameAC220
    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, AC010220·2HCl, ASP2689•2HCl, IT01
    D.3.9.3Other descriptive nameN-[(5-tert-butyl)isoxazol-3-yl]({4-[7-(2-morpholin-4-ylethoxy)(4-hydroimidazo[2,1-b]benzothiazol-2-yl)]phenyl}amino)carboxamide dihydrochloride salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number135mg
    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] - Cancer [C04]
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determination of:
    •Composite complete remission rate, defined as the confirmed rate of complete remission (CR) plus complete remission with incomplete platelet (CRp) or incomplete hematological recovery (CRi) ( ie, CR + CRp + CRi)
    •Complete remission rate, defined as the confirmed rate of CR
    E.2.2Secondary objectives of the trial
    Determination of:
    •Duration and rates of remission
    •Disease-free survival (DFS)
    •Overall survival (OS) and treatment related mortality
    •Time to treatment (TTR)
    •Safety and tolerability with emphasis on ECG changes
    •Pharmacokinetic (PK) and pharmacodynamic (PD) parameters
    •Impact of AC220 treatment on hematological parameters, improvement 'bridging patients to transplant', disease control, blood and platelet transfusions, infections, days in hospital, performance status (ECOG scale)
    • Pharmacogenetic analysis of FMS-like tyrosine kinase 3 (FLT3) internal tandem duplication (ITD) ie, FLT3-ITD
    • Correlation of remission with FLT3-ITD allelic ratio and other parameters using other assays
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females age ≥ 18 years
    2. Understand and voluntarily sign the informed consent form for this study
    3. Available for periodic follow-up at the investigative site
    4. Able to swallow the liquid study drug
    5. Morphologically documented primary AML or AML secondary to myelodsyplastic syndrome (MDS) as defined by the World Health Organization (WHO) criteria, as determined by pathology review at the treating institution, and confirmed later by the Sponsor-designated central laboratory. Patients must also meet the
    following criteria
    •≥ 60 years of age who are relapsed after 1 first-line chemotherapy regimen (with or without consolidation) and
    after first complete remission (CR1) < 12 months or are primary refractory to first-line chemotherapy, or
    •≥ 18 years of age who are relapsed or refractory after 1 second line (salvage) regimen or relapsed or refractory after HSCT
    •Must provide a sample for determination of FLT3-ITD mutation status as outlined
    in Section 10.6.1.
    6. ECOG performance status of 0 to 2 (Appendix 4)
    7. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents, including immunosuppressive therapy post HSCT. The use of chemotherapeutic or antileukemic agents other than hydroxyurea (as defined in the protocol) is not permitted during the study with the possible exception of intrathecal (IT) therapy for patients with CNS leukemia in remission at the discretion of the Investigator and with the agreement of the Sponsor.
    8. Persistent chronic clinically significant nonhematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
    9. Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.
    10. Serum creatinine ≤ 1.5 × ULN (upper limit of normal) and glomerular filtration rate (GFR)> 30 mL/min (calculated by Cockcroft and Gault formula, Appendix 6).
    11. Serum potassium, magnesium, and calcium levels (corrected serum calcium values for hypoalbunemia should be used) should be at least within institutional normal limits, and every effort should be made to keep potassium concentrations above 4.0 mEq/dL, magnesium concentrations above 1.8 mg/dL, and serum calcium at normal concentration (corrected serum calcium values for hypoalbunemia are acceptable) with the administration of oral/IV potassium and/or magnesium and/or calcium replacement during the study. If this is not possible, potassium and magnesium (and calcium) concentrations should at least be kept within institutional normal limits.
    12. Total serum bilirubin ≤ 1.5 x ULN (upper limit of normal)
    13. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 x ULN
    14. Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP).
    15. WOCBP must be using an adequate and medically accepted method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study in such a manner that the risk of pregnancy is minimized. WOCBP includes any female that has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not post menopausal (defined as amenorrhea >12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level >35 mIU/mL). Additionally, women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or are practicing abstinence or where the partner is sterile (eg, vasectomy), should be considered to be of childbearing potential.
    16. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 72 hours prior to the start of study drug.
    E.4Principal exclusion criteria
    1. Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor
    2. Diagnosis of acute promyelocytic leukemia
    3. Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
    4. AML in relapse or refractory after 3 or more previous lines of chemotherapy treatment (ie, first-line chemotherapy with or without consolidation [first line], first salvage [second line], and second salvage [third line] or subsequent regimens)
    5. AML or antecedent MDS secondary to prior chemotherapy
    6. Persistent clinically significant nonhematological toxicity that is Grade > 1 by NCI CTCAE v4 from prior chemotherapy
    7. Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have 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.
    8. Clinically active CNS leukemia. If CNS leukemia is controlled and patients are receiving IT therapy at study entry, patients may be considered eligible at the discretion of the Investigator and with agreement of the Sponsor. Patients should continue to receive IT therapy as clinically indicated.
    9. Patients who have previously received AC220
    10. Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)
    11. Major surgery within 4 weeks prior to enrollment in the study
    12. Radiation therapy within 4 weeks prior to, or concurrent with, study
    13. Use of concomitant drugs that prolong QT/QTc interval or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient, but only if clinically indicated and must be fully documented in the CRF (recommended washout of 5 half-lives prior to patient’s first dose with AC220).
    14. Uncontrolled or significant cardiovascular disease, including :
    • A myocardial infarction within 12 months
    • Uncontrolled angina within 6 months
    • Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is ≥ 45% (or institutional lower limit of normal value).
    • Diagnosed or suspected congenital long QT syndrome
    • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes [TdP]); any history of arrhythmia will be discussed with the Sponsor’s Medical Monitor prior to patient’s entry into the study.
    • Prolonged QTcF interval on pre-entry ECG (≥450 ms)
    • Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)
    • Heart rate < 50/minute on pre-entry ECG
    • Uncontrolled hypertension
    • Obligate need for a cardiac pacemaker
    • Complete left bundle branch block
    • Atrial fibrillation
    15. WOCBP who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period and for at least 3 months after the study
    16. Women who are pregnant or breastfeeding
    17. WOCBP with a positive pregnancy test
    18. Men who are unwilling or unable to use an acceptable method of birth control if their sexual partners are WOCBP for the entire study period and for at least 3 months after completion of the study
    19. Active uncontrolled infection
    20. Known infection with human immunodeficiency virus (HIV)
    21. Known active hepatitis B or C or other active liver disease
    22. Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study
    23. History of cancer, except treated Stage 1 cervix or nonmelanotic skin cancer and with the possible exception of patients in complete remission at the discretion of the Investigator, and with agreement of the Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be primarily evaluated by the confirmed CR and CRc rate (CR+ CRp + CRi), duration of remission, DFS, TTR, and OS. Response will be assessed per Cheson criteria [ref], which will be modified for assessment of CRi as indicated in Section 10. 2.4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    •Bone marrow aspirates and/or biopsies (both bone marrow aspirates and biopsies are preferred, but biopsies may be omitted at the discretion of the Investigator if an adequate aspirate is obtained) are required at Screening (within 14 days prior to first dose of AC220), Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (unless the patient has already achieved a complete remission [CR, CRp, or CRi], in which case bone marrow aspirate and/or biopsy will be repeated after every 3
    subsequent cycles), and at the Early Termination/End of Study Visit, and
    as clinically indicated per the conditions mentioned below. These samples will be evaluated as specified in the protocol for assessment of remission.
    •Best Response
    E.5.2Secondary end point(s)
    •Duration of remission, DFS, TTR, and OS
    •Hematological improvement will also be assessed as well as impact of treatment with AC220 on blood and platelet transfusions, infections, days of hospitalization (including days in intensive care), performance status (ECOG scale), providing a "bridge to transplant," and duration of leukemia/disease control.
    •Pharmacogenetic analysis of FLT3-ITD mutation
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Duration of Remission: Time from first fully documented remission until documented relapse. Every effort must be made to capture subsequent antileukemic therapies (if any) and outcomes, which will be documented in the CRF.
    •Disease Free Survival (DFS): Same as duration of remission not censored at death.
    •Time to Treatment Response (TTR): Time from the first dose of AC220 (Cycle 1 Day 1) until the first measured response (CR, CRp, CRi, or PR). Time to best response will also be assessed, and is the time from the
    first dose of AC220 (Cycle 1 Day 1) until best response.
    •Overall Survival (OS): Time from patient's first dose of study drug until death.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Canada
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit of the last subject
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 300
    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)
    All the subjects will receive local standard of care for their condition
    after their participation in the trial.
    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 Decision2010-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-18
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