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    Summary
    EudraCT Number:2013-004458-34
    Sponsor's Protocol Code Number:Nipawilma_2013
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-004458-34
    A.3Full title of the trial
    A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Nintedanib/Vargatef in Combination With Paclitaxel Chemotherapy for Treatment of Patients with BRAF Wildtype Metastatic Melanoma
    Multizentrische, randomisierte, doppelt verblindete, placebo-kontrollierte Phase I/II-Studie zur Prüfung der Wirksamkeit und Sicherheit von Nintedanib/Vargatef in Kombination mit Paclitaxel-Chemotherapie zur Behandlung von Patienten mit BRAF Wildtyp metastasiertem Melanom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to investigate the efficacy and safety of nintedanib/vargatef when combined with paclitaxel (chemotherapy) for treatment of patients suffering from metastatic melanoma with BRAF wildtyp
    A.3.2Name or abbreviated title of the trial where available
    Nipawilma
    A.4.1Sponsor's protocol code numberNipawilma_2013
    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 SponsorUniversity of Essen
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportmedac Gesellschaft für klinische Spezialpräparate m.b.H.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Essen
    B.5.2Functional name of contact pointDepartment of Dermatology
    B.5.3 Address:
    B.5.3.1Street AddressHufelandstr. 55
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45122
    B.5.3.4CountryGermany
    B.5.4Telephone number00492017234345
    B.5.5Fax number00492017235935
    B.5.6E-maildirk.schadendorf@uk-essen.de
    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 Vargatef
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 nameNintedanib 100mg capsules
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.4EV Substance CodeSUB120728
    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) 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 Taxomedac
    D.2.1.1.2Name of the Marketing Authorisation holdermedac Gesellschaft für klinische Spezialpräparate mbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number6
    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: 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 Yes
    D.2.1.1.1Trade name Vargatef
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 nameNintedanib 150 mg capsules
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.4EV Substance CodeSUB120728
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    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
    Advanced (unresectable stage III or IV) BRAF V600 wildtype
    cutaneous malignant melanoma
    E.1.1.1Medical condition in easily understood language
    Advanced melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    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
    The objectives of this study are to characterize the safety and to
    estimate the efficacy of nintedanib when combined with paclitaxel
    chemotherapy compared with paclitaxel chemotherapy alone in
    patients with BRAF wildtype metastatic melanoma not previously
    treated with taxanes or kinase inhibitors.
    The primary endpoint of Phase I is the definition of the Maximum Tolerable Dose (MTD) of the nintedanib/paclitaxel combination treatment.
    The primary endpoint of Phase II is the progression-free survival (PFS) according to RECIST v1.1.
    E.2.2Secondary objectives of the trial
    Overall survival
    • Safety and toxicity (graded according to CTCAE, Version 4.0)
    • Quality of Life (EORTC QLQ-C30) during therapy (i.e. until
    end of treatment visit)
    • Translational research project: identification and evaluation of
    prognostic and predictive biomarkers by analysis of tumor
    tissue and serum samples
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational research project: identification and evaluation of prognostic and predictive
    biomarkers by analysis of tumor tissue and serum samples
    E.3Principal inclusion criteria
    1. Histologically confirmed, (surgically incurable or unresectable) stage III or IV, BRAF
    V600 wildtype metastatic cutaneous malignant melanoma.
    2. Written informed consent
    3. A minimum of 1 measurable lesion according to RECIST v1.1 criteria.
    4. ECOG performance status of 0-1.
    5. Adequate hematologic, renal and liver function as defined by laboratory values
    performed within 14 days prior to initiation of dosing:
    • Hematologic:
    o Absolute neutrophil count (ANC) ≥1.5 x 109/L
    o Hemoglobin ≥ 9 g/dL (5.6 mmol/L; Subjects may not have had a transfusion
    within 7 days of screening assessment)
    o Platelets: ≥ 100 x 109/L
    • Hepatic
    o Total bilirubin: ≤ 1.0 x ULN
    o AST and ALT: ≤ 1.5 x ULN (In the case of liver metastases: 2.5 x ULN)
    • Renal
    o Serum creatinine: ≤ 1.5 mg/dL (133 ╬╝mol/L) or, if greater than 1.5 mg/dL:
    Calculated creatinine clearance: ≥ 50 mL/min
    6. Women of childbearing potential (WOCBP) should be using an effective method of
    contraception (Pearl-Index <1) to avoid pregnancy for at least 6 months after completion
    of paclitaxel treatment and for at least 3 months after completion of nintedanib/placebo
    monotherapy as directed by their physician. Women will be considered to be of
    childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal
    ligation/salpingectomy, or post-menopausal for at least two years. WOCBP must have a
    negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units
    of HCG) up to 28 days prior to commencement of dosing.
    7. Men should use an effective method of contraception during treatment and for at least 6
    months after completion of paclitaxel treatment and for at least 3 months after
    completion of nintedanib/placebo monotherapy as directed by their physician.
    8. Patients must have recovered from all prior treatment-related toxicities to NCI CTCAE
    (v4.0) Grade of 0 or 1, except for toxicities not considered a safety risk such as alopecia.
    9. Male or female, aged 18 years or older
    10. Life expectancy at least 3 months
    E.4Principal exclusion criteria
    1. Prior systemic therapy with taxanes or kinase inhibitors. Any prior therapy for metastatic
    disease must have been discontinued at least 4 weeks prior to initiation of dosing.
    2. Major surgery or radiation therapy within 4 weeks of starting the study treatment (minor
    surgical procedures such as biopsies are allowed, however patients must have
    recovered).
    3. Known inherited predisposition to bleeding or thrombosis and therapeutic
    anticoagulation (except low-dose heparin and/or heparin flush as needed for
    maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for
    low-dose therapy with acetylsalicylic acid < 325mg per day)
    Patients with the following coagulation parameters will be excluded:
    o International normalised ratio (INR) > 2
    o Prothrombin time (PT) and partial thromboplastin time (PTT): > 50% of deviation
    of institutional ULN
    4. History of clinically significant haemorrhagic or thromboembolic event in the past 6
    months
    5. NCI CTCAE (V4.0) grade 3 hemorrhage within 4 weeks of starting the study treatment.
    6. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
    within 6 months prior to randomization.
    7. Serious, non-healing wound, ulcer, or bone fracture.
    8. Known CNS disease.
    9. Previous Grade 2 or higher sensory neuropathy.
    10. History of or known spinal cord compression, or carcinomatous meningitis, or evidence
    of active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment
    with radiotherapy, symptomatic, requiring treatment with anti-convulsants;
    dexamethasone therapy will be allowed if administered as stable dose for at least one
    month before randomization) or leptomeningeal disease on screening CT or MRI scan.
    11. Any of the following within the 6 months prior to enrolment: myocardial infarction,
    severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
    congestive heart failure, cerebrovascular accident or transient ischemic attack, or
    pulmonary embolism.
    12. New York Heart Association (NYHA) Grade II or greater congestive heart failure.
    13. Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade ≥ 2.
    14. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or
    diastolic blood pressure > 100 mmHg on antihypertensive medications).
    15. Symptomatic peripheral vascular disease.
    16. Proteinuria at screening as demonstrated by urine dipstick for proteinuria ≥ 2+ (patients
    discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a
    24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
    17. Known hypersensitivity reaction to any of the components of study treatment (e.g.
    contrast media) or other severe acute or chronic medical or psychiatric condition or
    laboratory abnormality that may increase the risk associated with study participation or
    study drug 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.
    18. Previous cancer (unless a RFS interval of at least 5 years) with the exception of
    surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of
    the skin.
    19. Known clinically uncontrolled infectious disease including HIV positivity or AIDS-related
    illness and active or chronic hepatitis C and/or B infection.
    20. Pregnancy (absence to be confirmed by ß-hCG test) or lactation period.
    21. Psychological, familial, sociological or geographical factors potentially hampering
    compliance with the study protocol and follow-up schedule
    22. Active alcohol or drug abuse
    23. Treatment with other investigational drugs or treatments in another clinical trial within the
    past four weeks before start of therapy or concomitantly with this trial.
    24. Legal incapacity or limited legal capacity
    25. Significant weight loss (> 10% of body weight) within past 6 months prior to inclusion into
    the trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of Phase I is the definition of the Maximum Tolerable Dose (MTD) of
    the nintedanib/paclitaxel combination treatment.
    The primary endpoint of Phase II is the progression-free survival (PFS) according to RECIST
    v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 month after start of treatment
    E.5.2Secondary end point(s)
    - Overall survival
    - Safety and toxicity (graded according to CTCAE, Version 4.0)
    - Quality of Life (EORTC QLQ-C30) during therapy (i.e. until end of treatment visit)
    - Translational research project: identification and evaluation of prognostic and predictive
    biomarkers by analysis of tumor tissue and serum samples
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 month after start of treatment
    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 No
    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
    Assessment of tolerable dosis of nintedanib when combined 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 No
    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) 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 concerned10
    E.8.5The trial involves multiple Member States No
    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 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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 state126
    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)
    normal treatment of that condition
    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 Decision2014-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-12
    P. End of Trial
    P.End of Trial StatusOngoing
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