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    Summary
    EudraCT Number:2011-004363-74
    Sponsor's Protocol Code Number:A6181202
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-22
    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 ConcernedEstonia - SAM
    A.2EudraCT number2011-004363-74
    A.3Full title of the trial
    A SINGLE ARM OPEN LABEL INTERNATIONAL MULTI CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT®) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Sunitinib in Patients with Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
    A.4.1Sponsor's protocol code numberA6181202
    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 SponsorPfizer Inc., 235 East 42nd Road, New York, NY 10017
    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 supportPfizer Inc., 235 East 42nd Road, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClincial Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001800718 1021
    B.5.5Fax number001303739 1119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.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 Yes
    D.2.1.1.1Trade name Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSutent
    D.3.2Product code  
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSutent
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.9.3Other descriptive nameSUNITINIB MALATE
    D.3.9.4EV Substance CodeSUB22366
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Yes
    D.2.1.1.1Trade name Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSutent
    D.3.2Product code  
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSutent
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.9.3Other descriptive nameSUNITINIB MALATE
    D.3.9.4EV Substance CodeSUB22366
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    PROGRESSIVE ADVANCED METASTATIC WELL DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS
    E.1.1.1Medical condition in easily understood language
    progressive, advanced/metastatic well-differentiated, unresectable pancreatic neuroendocrine tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10068916
    E.1.2Term Pancreatic neuroendocrine tumor 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm sunitinib treatment effect on progression-free survival (PFS) per investigator assessment in subjects with advanced/metastatic, well differentiated, unresectable, pancreatic neuroendocrine tumors per RECIST.
    E.2.2Secondary objectives of the trial
    • To assess PFS per independent radiological review;
    • To assess time to tumor progression (TTP);
    • To assess overall survival (OS);
    • To assess objective response rate (ORR);
    • To assess duration of response (DR);
    • To assess time to tumor response (TTR);
    • To evaluate the use of Choi criteria;
    • To evaluate Chromogranin A response;
    • To assess the safety and tolerability of sunitinib;
    • To assess patient reported outcomes (PROs);
    • To explore the potential relationship between plasma soluble KIT levels and measures of efficacy including PFS;
    • To assess sunitinib and SU12662 (active metabolite of sunitinib) plasma trough concentrations (Ctrough) and to potentially explore the relationship between Ctrough and safety, biomarker, and efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Histologically or cytologically proven diagnosis of well differentiated pancreatic neuroendocrine tumor (according to WHO 2000 classification) with available Ki-67 index.
    4. Unresectable (as assessed by the investigator) or metastatic disease documented on a scan (CT, MRI, or Octreoscan) taken within 28 days of study enrollment. Disease progression (per RECIST 1.0) within 12 months prior to study enrollment.
    5. Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
    6. Presence of at least one measurable target lesion for further evaluation according to RECIST 1.0 (contrast enhancing lesion with the largest diameter ≥20 mm, based on conventional CT scan (or ≥10 mm with spiral CT scan) done within 3 weeks before the start of treatment).
    7. Adequate organ function as defined by the following:
    • Serum aspartate aminotransferase (AST; serum glutamate oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate pyruvate transferase [SGPT]) ≤2.5 x upper limit of normal (ULN). If liver function abnormalities are due to liver metastases, then AST and ALT may be ≤5 x ULN;
    • Total serum bilirubin ≤1.5 x ULN;
    • Absolute neutrophil count (ANC) ≥1500/μL;
    • Platelets ≥100,000/μL;
    • Hemoglobin ≥9.0 g/dL.
    8. ECOG Performance status 0 or 1.
    9. Life expectancy ≥3 months.
    10. Age ≥18 years.
    11. Able to swallow oral compound.
    12. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 3 months after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    E.4Principal exclusion criteria
    1. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2. Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification).
    3. Prior treatment with any tyrosine kinase inhibitors, anti-VEGF angiogenesis inhibitors, non-VEGF-targeted angiogenesis inhibitors, or mTOR inhibitors.
    4. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
    5. Treatment with strong CYP3A4 inhibitors and inducers within 7 and 12 days, respectively, prior to study drug administration.
    6. Pre existing abnormality of thyroid function with TSH that cannot be maintained in the normal range with medication.
    7. Concomitant treatment with therapeutic doses of anticoagulants. Low dose warfarin (Coumadin) up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed.
    8. Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections.
    9. Participation in other studies within 4 weeks before baseline scans (ie, screening) before the current study begins and/or during study participation.
    10. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
    11. Abnormal cardiac function with abnormal 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTC grade ≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
    12. Symptomatic brain metastases, spinal cord compression, or new evidence of brain or leptomeningeal disease.
    13. Left ventricular ejection fraction (LVEF) ≤50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).
    14. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 3 months after the last dose of the investigational product.
    15. Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness (testing not required in the absence of clinical suspicion).
    16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigationl product administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS): The primary endpoint is investigator assessed PFS according to RECIST 1.0. PFS is defined as the time from date of enrollment to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS data will be censored on the date of the last tumor assessment on study for subjects who do not have objective tumor progression and who do not die while on study. Subjects lacking an evaluation of tumor response after enrollment will have their PFS time censored on the date of enrollment with a duration of 1 day.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression-Free-Survival (PFS): at Cycle 2 Day 1, Cycle 3 Day 1 and then every 2 cycles thereafter, and at EOT visit.
    E.5.2Secondary end point(s)
    • Progression free survival will also be assessed by independent radiological review per RECIST.
    • To assess time-to-tumor-progression (TTP) is defined as the time from enrollment to first documentation of objective tumor progression.
    • Survival time is defined as the time from date of enrollment to date of death. In the absence of confirmation of death, survival time will be censored to last date the subject is known to be alive.
    • The objective response (OR) is the overall objective response recorded from enrollment until disease progression. A subject will be considered to have achieved an OR if the subject has a sustained complete response (CR) or partial response (PR) according to RECIST 1.0 definitions for at least 4 weeks, confirmed by repeat tumor assessments. Otherwise, the subject will be considered as not meeting OR criteria. Additionally, subjects with inadequate data for tumor assessment (eg, no baseline assessment or no follow up assessments) will be considered as not meeting OR criteria.
    • Duration of response (DR) is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
    • Time to tumor response (TTR) is defined as the time from date of enrollment to first documentation of objective tumor response that is subsequently confirmed.
    • ORR, DR, and TTR will also be assessed using Choi criteria for response.
    • Chromogranin A response rate.
    • Patient reported outcomes (PROs), defined as health related quality of life using the self administered European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and EORTC QLQ-GI.NET21. Subjects will complete the questionnaire at the clinic prior to administration of study medications or other clinical activities on Day 1 and every 4 weeks thereafter, at end of treatment/withdrawal, as well as 28 days post treatment.
    • Plasma samples for soluble KIT analysis will be collected before dosing at specified timepoints indicated in the Schedule of Activities.
    • Observed and dose corrected trough concentrations, estimated pharmacokinetic parameters such as steady state area under the curve (AUC24) and oral clearance (CL/F) for sunitinib and its active metabolite SU012662, as well as pharmacokinetic-pharmacodynamic parameters such as sunitinib concentration at which 50% of the maximum sunitinib effect is observed (EC50) with respect to selected safety, biomarker, and efficacy endpoints.
    • Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0), timing, seriousness, and relatedness of adverse events, laboratory abnormalities, physical examination findings, vital signs, weight and ECOG performance status.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • progression-free survival is assessed in Cycle 2 Day 1, Cycle 3 Day 1, then every 2 cycles and at EOT visit
    • survival time: each Day 1 of each cycle, EOT, 28 days post treatment visit, at each phone contact during post-study survival follow-up
    • The Objective Response (OR): at Cycle 2 Day 1, Cycle 3 Day 1, then every 2 cycles thereafter, at EOT visit
    • DR: at Cycle 2 Day 1, Cycle 3 Day 1, then every 2 cycles, at EOT visit
    • TTR: at Cycle 2 Day 1, Cycle 3 Day 1, then every 2 cycles, at EOT visit
    • ORR, DR, and TTR also assessed at Cycle 2 Day 1, Cycle 3 Day 1, then every 2 cycles, at EOT visit
    • Chromogranin A response rate: at Cycle 1 Day 1 and Day 15, Cycle 2 Day 1, Cycle 3 Day 1, then every 2 cycles, at EOT visit

    for more details please refer to protocol section 7
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability of Sutent
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    historical comparator group
    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
    historical comparator group
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Australia
    Belgium
    Brazil
    Czech Republic
    Estonia
    France
    Hungary
    India
    Italy
    Japan
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    South Africa
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of Trial in all participating countries is defined as collection of the final data point in the study. Because this clinical trial includes a survival endpoint, the last point is anticipated to be the last survival follow up (ie, date of last known alive or of death) prior to the cut off date for database lock for the Supplemental Clinical Study Report for Overall Survival.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    none as per protocol
    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 Decision2012-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-26
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