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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42319   clinical trials with a EudraCT protocol, of which   6970   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-005108-89
    Sponsor's Protocol Code Number:VHIO17002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-28
    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 - PEI
    A.2EudraCT number2017-005108-89
    A.3Full title of the trial
    Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumors.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A modular multi-Basket trial to improve personalized medicine in cancer patients
    A.4.1Sponsor's protocol code numberVHIO17002
    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 SponsorVall d’Hebron Institute of Oncology (VHIO)
    B.1.3.4CountrySpain
    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 supportF.Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportTaiho Oncology Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall d’Hebron Institute of Oncology (VHIO)
    B.5.2Functional name of contact pointSusana Munoz
    B.5.3 Address:
    B.5.3.1Street AddressCellex Building; Carrer Natzaret, 115-117
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 932 543 450 8614
    B.5.6E-mailsmunoz@vhio.net
    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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    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.3.4Pharmaceutical form Concentrate 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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameFutibatinib
    D.3.2Product code TAS-120
    D.3.4Pharmaceutical form 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 INNFUTIBATINIB
    D.3.9.1CAS number 1448169-71-8
    D.3.9.2Current sponsor codeTAS-120
    D.3.9.3Other descriptive nameTAS-120
    D.3.9.4EV Substance CodeSUB130443
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Subjects with advanced solid tumour
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    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 primary objective is to evaluate the antitumour activity of each matched therapy in small subject populations as a signal finding study.
    E.2.2Secondary objectives of the trial
    • To determine the prevalence of genetic alteration in the iPROFILER screened population.
    • To evaluate the clinical benefit of matching therapies in small patient populations.
    • To evaluate the safety and tolerability of each investigational agent tested as assessed by the incidence and severity of adverse events.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Radiomics sub-study (Module 1 specific):
    • The primary objective of this sub-study is to evaluate CT-radiomics signature of solid tumours that predicts response to atezolizumab.
    • The secondary objectives are to evaluate early changes in CT-radiomics signatures as response to atezolizumab, to evaluate correlation of radiomics features with tumour mutational status to develop radiogenomics phenotypes, and to evaluate correlation of CT-radiomics features with histological features from tumour samples.

    SIMPATHY sub-study (Module 1 specific):
    • SIMPATHY sub-study aims to produce a detailed map of the tumour immune microenvironment before, during and after failure of ICI treatment with the anti-PDL1 monoclonal atezolizumab, contextualized with genomic and systemic immune features.
    E.3Principal inclusion criteria
    Part A:
    1. Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist.
    2. Subjects must have ECOG performance status of 0 or 1.
    3. Subjects must be 18 year-old or older.
    4. Subjects must have measurable disease according to RECIST 1.1.
    5. Subjects must have enough tumour tissue for molecular analysis
    • Subjects providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 20 to 28 slides depending on the sample tumour cellularity. If there is not enough archival tissue to meet this criterion, the subject must undergo a tumour biopsy.
    • Subjects providing fresh frozen tissue (FFT) must provide 4 core biopsies or equivalent. FFT must be preferentially collected from a tumour biopsy; hence, patients must have disease amenable to be biopsied. Otherwise, the subject should have FFT stored in a biobank or biorepository.
    • Efforts will be made to provide FFT in at least one quarter of the participating subjects. The proportion of subjects that might provide FFT might change based on the results from the molecular analysis.
    • Since some of the tests are performed in FFPE tissue, patients providing FFT from a recent biopsy will have part of the sample processed in FFPE tissue as per Laboratory manual.
    6. Subjects must have adequate hematological function: absolute granulocyte count ≥ 1.5 × 10 9/L, platelet count ≥ 100 × 10 9/L.
    7. Subject must have adequate renal and hepatic function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 30ml/min, serum bilirubin ≤ 1.5 × ULN; unless due to Gilbert’s syndrome, AST/ALT ≤ 5 × ULN if liver metastases are present or AST/ALT ≤ 3 × ULN if
    the subject has no liver involvement.
    8. For subjects requiring a tumour biopsy: patients must have adequate coagulation function quick time ≥ 60% or INR ≤ 1.5
    9. Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour
    10. Ability to understand and the willingness to sign a written informed consent document.
    Part B:
    Inclusion criterion 2/3/4/6/8/9/10/12 from part A
    1. Subjects must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or tumours for which standard therapy does not exist, or subjects may be unable to receive standard therapy.
    2. Subjects must have adequate renal and hepatic function:
    • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 − age) × (weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL)
    • Serum bilirubin ≤ 1.5 × ULN; with the following exception: subjects with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled
    •AST, ALT, and alkaline phosphatase < 2.5 x ULN, with the following exceptions:
    oPatients with documented liver metastases: AST and ALT < 5 x ULN
    oPatients with documented liver or bone metastases: alkaline phosphatase < 5 x ULN
    3. Subjects receiving therapeutic anticoagulation (such as low−molecular weight heparin or warfarin) should be on a stable dose
    4.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year (when used consistently and correctly) during the treatment period and for at least 5 months after the last dose of atezolizumab/ 6 months after the last dose of Futibatinib, in case of being included in Part B of the study. Please see protocol for more details.
    5.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in the protocol

    (Please refer to section 3.1 Inclusion Criteria of iProfiler, Module 1 and 2 for full list)
    E.4Principal exclusion criteria
    Part A
    1.Subjects with leptomeningeal disease should be excluded from this clinical trial.
    2.Subjects with known unstable brain metastases should be excluded from this clinical trial.
    •Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size for six months after having completed therapy.
    3.Subjects with spinal cord compression not definitively treated with surgery and/or radiation.
    4.Subjects with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF < 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    5.Subjects with inability to swallow tablets or capsules.
    6.Subjects with known HIV, hepatitis B or hepatitis C infection.
    7.Subjects with known history of malabsorption.
    Part B:
    1.Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to Day 1. This negative test will be valid for Cycle 1 day 1. In subsequent cycles, serum pregnancy test will be performed on day 1 of each cycle, with a +/- 3 day window, and prior to drug administration.
    2.Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
    •Hormone-replacement therapy or oral contraceptives.
    •Somatostatin analogues for the treatment of symptoms related with neuroendocrine tumours.
    •Gonadotropin-releasing hormone agonists or antiandrogens for prostate cancer.
    •Palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1.
    3.Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.
    4.Treatment with an investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer), with the exception of monoclonal antibodies. Based on the half-life of monoclonal antibodies and the limited overlap on toxicities, a 4 week wash-out period will be allowed.
    5.Subjects with known unstable brain metastases should be excluded from this clinical trial.
    •Exception: Subjects with treated brain metastasis which remain stable or responding 6 weeks after completing radiotherapy can be included.
    6.Uncontrolled intercurrent illness including, but not limited to, active infection, cardiovascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.
    7.Subjects with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.
    •Subjects with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible.
    •Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
    8.Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable arrhythmias or unstable angina.
    9.Another primary malignancy other than disease under study within 2 years prior to Cycle 1 Day 1, unless consider at low risk of relapse at Investigator discretion.
    10.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, fusion proteins or any excipient of the experimental product.
    11.Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
    13. Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
    • Influenza vaccination can be given during influenza season only (example: approximately October to March in the Northern Hemisphere), but subjects must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.
    14. History of active tuberculosis.
    15. Contraindications included in the product information of the drugs used in the study.
    Please refer to section 3.2 Exclusion Criteria for full list of iProfiler, Module 1 and 2.
    E.5 End points
    E.5.1Primary end point(s)
    Module 1 & 2:
    • Overall response rate (ORR) or complete response (CR) by RECIST 1.1 of different targeted agents in molecularly selected small patient populations.

    No specific primary endpoint in iProfiler (Part A) protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12 (Module 1)
    At Week 16 (Module 2)
    E.5.2Secondary end point(s)
    Specific Secondary Endpoints for iProfiler (Part A):
    •To determine the prevalence of genetic alterations in the iPROFILER screened population.

    • Progression free survival (PFS by RECIST 1.1) of the patients treated with each investigational agent evaluated at the end of the module.
    • Progression Free Survival (PFS by RECIST 1.1) at 6 months of subjects treated with each investigational agent.
    • Overall survival (OS) of subjects treated with each investigational agent evaluated at the end of each module.
    • Incidence and severity of adverse events (AEs) in subjects receiving each investigational agent.

    Specific Secondary Endpoints for Module 2:
    • Duration of response (CR or PR), calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death. Data from subjects who are progression-free and alive or have unknown status will be censored at the last tumour assessment.

    E.5.2.1Timepoint(s) of evaluation of this end point
    - Progression free survival at the end of the module.
    - Progression Free Survival at 6 months
    - Overall survival at the end of the module
    - Safety, continued evaluation during the trial
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open 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
    basket of basket study, modular study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    End of the each module will be considered 6 months after the last dose of the last participant patient in that specific module (after the Follow-up visit) or until all subjects have died, withdrawn consent or are lost to follow-up (whichever occurs first). A subject will be considered lost to follow up when reasonable attempts are made by the site to contact him/her without success.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    No plans for treatment after the subject has ended the participation in the trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-11
    P. End of Trial
    P.End of Trial StatusOngoing
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