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    Summary
    EudraCT Number:2014-001216-19
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-001216-19
    A.3Full title of the trial
    Short-course radiotherapy plus olaparib for newly diagnosed glioblastoma in patients unsuitable for radical chemoradiation: a randomised phase II clinical trial preceded by a lead-in phase I dose escalation study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Short-course radiotherapy plus olaparib for patients with a primary brain tumour and not suitable for radical chemo-radiation.
    A.3.2Name or abbreviated title of the trial where available
    PARADIGM: Olaparib And Radiotherapy In newly-diagnosed Glioblastoma
    A.4.1Sponsor's protocol code number
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN52658296
    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 SponsorNHS Greater Glasgow & Clyde
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Glasgow
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 nameOlaparib
    D.3.2Product code AZD2281
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.4EV Substance CodeAS9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    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 nametemozolomide
    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 INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.4EV Substance CodeAS6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.4EV Substance CodeAS7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.4EV Substance CodeAS8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    glioblastoma
    E.1.1.1Medical condition in easily understood language
    primary brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 Phase I is to identify a recommended dose of olaparib to be administered in combination with radiotherapy.

    The primary objective of Phase II is to determine the effect of olaparib administered in combination with radiotherapy compared with placebo administered in combination with radiotherapy on life expectancy (overall survival) in patients with MGMT unmethylated, newly diagnosed glioblastoma who are not fit enough to receive aggressive treatment with both chemotherapy and radiotherapy.

    The primary objective of the dose escalation substudy is to identify a recommended dose of olaparib in combination with temozolomide and radiotherapy in patients with MGMT methylated, newly diagnosed glioblastoma.
    E.2.2Secondary objectives of the trial
    The secondary objectives of Phase I are to identify the DLT (Dose-Limiting Toxicity) of olaparib to be administered in combination with radiotherapy, and to explore the safety and tolerability of olaparib when administered in combination with radiotherapy.

    The secondary objectives of Phase II are to compare progression-free survival (PFS) survival in patients treated with olaparib administered in combination with radiotherapy or placebo administered in combination with radiotherapy,to further describe the safety and tolerability of olaparib when administered in combination with radiotherapy or placebo administered in combination with radiotherapy in this patient population, and to assess the impact of olaparib on quality of life.

    The secondary objectives of the dose escalation substudy are to identify the Dose Limiting Toxicity of olaparib when administered in combination with radiotherapy and concomitant temozolomide, and to explore the safety and tolerability of olaparib when admin
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Dose Escalation substudy has been incorporated into the current version of the protocol- Version 7 dated 17th May 2018. Related objectives have been listed above in E2-1 and E2-2.
    E.3Principal inclusion criteria
    1. Age ≥70: WHO performance status 0 or 1 at initial oncology consultation

    2. Phase I only: Age 18 – 69: WHO performance status 2 at initial oncology consultation or performance status 0-1 but otherwise unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide

    3. Phase II and dose escalation substudy only:Age 65- 69; WHO performance status 0, 1 or 2 at initial oncology consultation and unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide

    4. Phase II and dose escalation substudy only: Age 18- 64; WHO performance status 2 at initial oncology consultation or performance status 0-1 but otherwise unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide

    5. Histologically confirmed diagnosis of glioblastoma

    6. Phase II and dose escalation substudy only; Sufficient tumour material for MGMT promoter methylation assay

    7. Life expectancy greater than 12 weeks

    8. No previous radiotherapy or chemotherapy for primary or secondary CNS malignancy

    9. Adequate haematological, hepatic and renal function defined as below:
    •Haemoglobin ≥ 100 g/L (no blood transfusions in the 28 days prior to trial entry)
    •Absolute neutrophil count ≥ 1.5 x 109/L
    •White Blood Cells ≥3x109/L
    •Platelet count ≥ 100 x 109/L
    •Bilirubin ≤ 1.5 x upper limit of normal (ULN)
    •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 x ULN
    •Adequate renal function with creatinine clearance / glomerular filtration rate > 50 ml/min. If the creatinine clearance / glomerular filtration rate is less than 50 ml/min as calculated by the Cockroft-Gault/Wright formula, then the creatinine clearance / glomerular filtration rate should be measured by either a radio-isotope technique or by 24-hour urine collection as per local practice

    10. Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed

    11. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures

    12. Ability to swallow oral medications

    13. Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 7 days of trial entry

    Post-menopausal is defined as:
    •Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
    •LH and FSH levels in the post-menopausal range for women under 50
    •Or surgical sterilisation (bilateral oophorectomy or hysterectomy)
    E.4Principal exclusion criteria
    1. WHO performance status >2

    2. Life expectancy less than 12 weeks

    3. Active concurrent malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If history of prior malignancy, must be disease-free for >5 years

    4. Prior treatment for primary or secondary CNS malignancy

    5. Confusion or altered mental state that would prohibit understanding and giving of informed consent

    6. Concomitant treatment with medicines listed as 'prohibited' or 'excluded' in section 5.10 of protocol

    7. Female patients who are able to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception detailed in section 7.1.12, effective at the first administration of olaparib, throughout the trial, and for at least one month afterwards, are considered eligible

    8. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception detailed in section 7.1.12, effective at the first administration of IMP, throughout the trial, and for three months afterwards or 6 months if receiving temozolomide). Men with pregnant or lactating partners should be advised to use barrier method contraception to prevent exposure to the foetus or neonate. Female partners (of childbearing potential) of male patients should also use a highly effective form of contraception as detailed in section 7.1.12

    9. Administration of any investigational drug within 28 days prior to receiving the first dose of trial treatment

    10. Any previous treatment with a PARP inhibitor, including olaparib

    11. Blood transfusions within 28 days prior to trial entry

    12. Patients with myelodysplastic syndrome/acute myeloid leukaemia

    13. Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of major surgery

    14. Patients with a known hypersensitivity to olaparib or temozolomide or dacarbazine or any of the excipients of the product

    15. Patients with uncontrolled seizures

    16. Patients who are known to be HIV positive, or who are known to have positive Hepatitis B or C serology

    17. Phase II only: Methylation of MGMT promoter region confirmed by central laboratory testing, or an inconclusive MGMT test result

    18. Dose escalation substudy only: Unmethylation of MGMT promoter region confirmed by central laboratory testing, or an inconclusive MGMT test result
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure of the Phase I part of the trial will be the recommended dose of olaparib when administered in combination with radiotherapy.

    For Phase II, the primary outcome measure is overall survival.

    For the dose escalation substudy, the primary outcome measure is the recommended dose of olaparin when administered in combination with radiotherapy and concomitant temozolomide.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint of evaluation of the primary endpoint for phase I is at the completion of phase I (estimated to be 18 months).

    For phase II, the current status of patients will be evaluated 2 monthly during follow-up and an overall evaluation of the primary endpoint of overall survival will be done at the end of the trial.

    The timepoint of evaluation of the primary endpoint for the dose escalation substudy is at the completion of the substudy (estimated to be 24 months).
    E.5.2Secondary end point(s)
    The secondary endpoints of Phase I are the DLT (Dose-Limiting Toxicity) and the safety and tolerability of olaparib administered in combination with radiotherapy.

    The secondary endpoints of Phase II are progression-free survival measured by MRI scans during follow-up and will be assessed in accordance with the RANO guidelines, toxicity measured using the CTCAE v.4.0 criteria and recorded at each follow-up visit, and quality of life which will be measured by the completion of QLQ30, BN20 and EQ-5D questionnaires completed by the participant at baseline and each follow-up visit.

    The secondary endpoints of the dose escalation substudy are the Dose-Limiting Toxicity (DLT) and the safety and tolerability of olaparib administered in combination with radiotherapy and concomitant temozolomide.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I secondary endpoints are monitored continuously throughout phase I, in particular at the end of each dose cohort.

    For phase II, the current status of patients will be evaluated 2 monthly during follow-up and an overall evaluation of the progression free survival will be done at the end of the trial.

    Dose escalation substudy secondary endpoints are monitored continuously throughout recruitment to the substudy, in particular at the end of each dose cohort.

    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.7.1.3.1Other trial type description
    Dose escalation study in combination with short-course radiotherapy
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose escalation substudy open label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned24
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 trial will be the date of the last data capture or when the last patient attends their last follow-up visit for the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months1
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 174
    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 state194
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    F.4.2.2In the whole clinical trial 194
    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)
    Radiotherapy can only be given once, and there are no plans for olaparib to be continued once the research has finished because it is being used primarily to improve the effects of radiotherapy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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