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    Summary
    EudraCT Number:2009-010551-26
    Sponsor's Protocol Code Number:D0102C00003
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-05
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2009-010551-26
    A.3Full title of the trial
    A Phase I/II Multi-centre Study of AZD8931 in Combination with Weekly
    Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy
    in Patients with Advanced Solid Tumours and in a Selected Population with
    Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer
    (THYME)
    A.3.2Name or abbreviated title of the trial where available
    THYME
    A.4.1Sponsor's protocol code numberD0102C00003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAZD8931
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeD0102C00000
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameAZD8931
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeD0102C00000
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameAZD8931
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeD0102C00000
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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: 4
    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.2.5The 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 namepaclitaxel
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePaclitaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Phase I part of the study: Solid tumours that are refractory to standard therapies
    Phase II part of the study: trastuzumab- or lapatinib-ineligible patients with locally advanced (not amenable to
    surgery) or metastatic breast cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the Phase I part of this study is:
    ∙ To investigate the MTD of AZD8931 in combination with
    weekly paclitaxel in patients with advanced solid malignancies, through
    assessment of safety and tolerability
    The primary objective of the Phase II part of this study is:
    • To compare the progression free survival (PFS) in patients treated with
    AZD8931 in combination with paclitaxel versus paclitaxel alone
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    1. To investigate whether there is any effect on the pharmacokinetics (PK) of
    AZD8931 and its metabolites and/or paclitaxel when co-administered
    2. To investigate the safety and tolerability of AZD8931 in combination with
    paclitaxel
    3. To compare the objective tumour response rate in patients treated with
    AZD8931 in combination with paclitaxel versus paclitaxel alone
    4. To compare the overall survival (OS) in patients treated with AZD8931 in
    combination with paclitaxel versus paclitaxel alone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients
    1. Provision of signed, written informed consent prior to any study specific procedures2. Age 18 years and older
    3. Radiotherapy must be terminated at least 2 weeks prior to enrolment and patients
    must have recovered from any toxic effects
    must have recovered from the toxic effects of prior therapy
    4. Suitable for paclitaxel therapy
    5. Estimated life expectancy of more than 12 weeks
    6. Not previously randomised to treatment in this study
    7. Females must be of non-childbearing status defined as one of the following criteria at screening:
    - negative pregnancy test in women of childbearing potential
    - women who are permanently or surgically sterilised (hysterectomy and/or bilateral
    oopherectomy and/or bilateral salpingectomy)
    - postmenopausal (over 50 years old and amenorrheic for 12 months following cessation of all exogenous
    hormonal treatments, or over 57 years old)
    8. Females must not be breastfeeding
    9. Female patients of child-bearing potential must use an acceptable highly
    effective method of contraception plus condoms plus spermicide during the study and for 30 days after the last dose of studt drug. It is recommended that women should have been stable on their chosen method of contraception for at least 3 months before entering the study. Recommended methods of contraception are listed in Appendix J
    10. Patients must not have received an investigational drug within 30 days or 5 half-lives, whichever is longer, of
    the first dose of randomised therapy (AZD8931 or matching placebo)
    11. Adequate liver function defined as;
    − serum bilirubin ≤2 x ULN
    − and ALT or AST ≤2.5 x ULN in the absence of noted liver metastases,
    − and ALP ≤2.5 x ULN in the absence of noted liver metastases,
    − or ALP, AST and ALT ≤5.0 x ULN if judged by the investigator to be related
    to liver metastases Elevated ALP is not exclusionary if due to the presence of
    bone metastasis and liver function is otherwise considered adequate in the
    investigator’s judgement
    Phase II only
    37. Female patients with histologic or cytologic diagnosis of breast cancer with
    evidence of locally advanced (not amenable to surgery) or metastatic disease.
    Lesions should not be amenable to surgery or radiation of curative intent
    38. Patients must not have received previous taxane therapy in an adjuvant or
    neo-adjuvant setting, within 12 months prior to the start of AZD8931/matching
    placebo
    39. Patients must not have received taxane treatment for treatment of locally advanced
    (not amenable to surgery) and/or metastatic breast cancer
    40. Patients must not have received more than one cytotoxic chemotherapy regimen for
    the treatment of locally advanced (not amenable to surgery) or metastatic breast
    cancer. (Previous treatment of the locally advanced, or metastatic breast cancer
    with endocrine therapy is permitted) NOTE: If during recruitment, it is determined
    that a high proportion of randomised patients have received prior chemotherapy for
    their locally advanced/metastatic disease, enrolment of new patients may be
    restricted to those with no previous cytotoxic chemotherapy for their locally
    advanced and/or metastatic disease.
    41 Patients must be deemed ineligible for trastuzumab or lapatinib treatment by local
    assessment. This should include IHC analysis to determine HER2 status with
    further testing by FISH/CISH when considered part of local practice.
    − Tumour tissue sample provision for central analysis is a mandatory part of the
    screening procedures and must be available. The sample can be taken from
    archival diagnostic tissue from the original biopsy or a more recent biopsy.
    Both primary lesion and metastatic sites are acceptable. Notification of patient
    eligibility will come from the central laboratory informing the site that HER2
    expression is within limits for randomisation.
    For optional pharmacogenetic component only (Phase I and Phase II)
    63. Provision of informed consent for genetic research
    64. No previous allogenic bone marrow transplant
    65. Any non-leukocyte depleted whole blood transfusion must have been received morethan 120 days prior to genetic sample collection
    E.4Principal exclusion criteria
    All the points included in this section are restrictions
    1 Female patients of child bearing potential must use an acceptable highly effective
    method of contraception plus condoms plus spermicide during the study and for
    30 days after last dose of AZD8931/matching placebo. Recommended methods of
    contraception are listed in Appendix J
    2 Patients should use sunglasses and sun cream with UVA and UVB protection SPF>30
    if exposed to sunlight and avoid use of sun tanning booths during the study and for
    3 months after the last dose of AZD8931/matching placebo
    3 Patients who are blood donors should not donate blood during the trial and for
    3 months following their last dose of AZD8931/matching placebo
    4 All patients must avoid concomitant use of medications, herbal supplements and/or
    ingestion of foods that significantly modulate CYP3A4 and/or CYP2D6 activity. Such
    drugs must have been discontinued for an appropriate period before they enter
    screening and for a period of 2 weeks after the last dose of AZD8931/matching
    placebo. Guidance on medications to avoid and on washout periods is given in
    Appendix D
    5 Refer to the Summary of Product Characteristics (SPC) for restrictions specific to
    paclitaxel
    6 Male patients (including those that have undergone a successful vasectomy) must use
    condoms plus spermicide during sexual contact with a female of child-bearing
    potential who is not using a highly effective method of contraception, for the duration
    of the study and for 3 months after the last dose of AZD8931
    7 Male patients will be advised to abstain from sperm donation from first dose until
    3 months following receipt of the last dose of AZD8931
    8 Refrain from driving for 4 hours following ophthalmic examination if pupillary
    dilatation performed
    9 Patients should refrain from wearing contact lenses from at least 1week prior to
    starting AZD8931 to 1 week after discontinuation of AZD8931

    Phase II only
    10 Patients who wear contact lenses should discontinue wearing their lenses if they have any mild to moderate eye symptoms (CTCAE grade ≤2) while receiving treatment with AZD8931/matching placebo until at least one week after symptoms have resolved. If a patient has a recurrence of eye symptoms or experiences any severe (CTCAE grade ≥3) ocular events they should discontinue wearing their contact lenses until at least one week after treatment with AZD8931/matching placebo is permanently discontinued
    11 Patients should not use any eye drops or ointment for treatment of eye symptoms, unless agreed by a study doctor, at any time during the study until 1 week after AZD8931/matching placebo has been permanently discontinued
    12 Patients should not receive endocrine therapy prior to progression of their disease
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variable – PFS
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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
    In combination with paclitaxel
    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 Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    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
    The end of study is defined as the point at which no patient will be exposed to study related procedures.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-05-05. Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 192
    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)
    Once patients receiving AZD8931 or matching placebo have been discontinued from study treatment, other treatment options will be at the discretion of 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 Decision2009-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-05
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