Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001802-27
    Sponsor's Protocol Code Number:F002MH0218_1
    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:2018-12-13
    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 number2018-001802-27
    A.3Full title of the trial
    A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Cabozantinib in Advanced (Unresectable or Metastatic) Adrenocortical Carcinoma.
    Eine multizentrische, offene Phase II Studie zur Evaluation von Sicherheit, Verträglichkeit sowie Wirksamkeit von Cabozantinib bei Patienten mit fortgeschrittenem (nicht resektablem oder metastasiertem) Nebennierenrindenkarzinom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter Study to investigate the Efficacy and Safety of Cabozantinib in Advanced Adrenocortical Carcinoma.
    Eine multizentrische Studie zur Untersuchung von Sicherheit, Verträglichkeit sowie Wirksamkeit von Cabozantinib bei Patienten mit fortgeschrittenem Nebennierenrindenkarzinom.
    A.3.2Name or abbreviated title of the trial where available
    CaboACC
    A.4.1Sponsor's protocol code numberF002MH0218_1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03612232
    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 Hospital Wuerzburg
    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 supportIpsen Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Wuerzburg
    B.5.2Functional name of contact pointDivision of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressOberduerrbacher Str. 6
    B.5.3.2Town/ cityWuerzburg
    B.5.3.3Post code97080
    B.5.3.4CountryGermany
    B.5.4Telephone number004993120139200
    B.5.5Fax number00499312016039126
    B.5.6E-mailKroiss_M@ukw.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 Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    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 nameCabozantinib
    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 INNCABOZANTINIB
    D.3.9.1CAS number 849217-68-1
    D.3.9.4EV Substance CodeSUB93452
    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.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 Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    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 nameCabozantinib
    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 INNCABOZANTINIB
    D.3.9.1CAS number 849217-68-1
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Advanced (Unresectable or Metastatic) Adrenocortical Carcinoma
    fortgeschrittenes (nicht resektables oder metastasiertes Nebennierenrindenkarzinom
    E.1.1.1Medical condition in easily understood language
    Cancer of the adrenal gland that cannot be removed by surgery or has spread to distant sites
    Nebennierenkarzinom, welches nicht operativ entfernt werden kann oder von dem Absiedelungen (Metastasen) an anderen Stellen im Körper bestehen.
    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 HLGT
    E.1.2Classification code 10001353
    E.1.2Term Adrenal gland disorders
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001341
    E.1.2Term Adrenal cortical hyperfunctions
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001376
    E.1.2Term Adrenal neoplasms
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001378
    E.1.2Term Adrenal neoplasms malignant
    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
    To determine the efficacy and safety of cabozantinib as a treatment for advanced adrenocortical carcinoma.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject who meets any of the following criteria is eligible for the study:
    1. The subject is ≥ 18 years old on the day of consent
    2. Histological confirmation of ACC based on either:
    i) Weiss Score of ≥ 3 in patients who had earlier surgical resection (Lin-Weiss-Bisceglia system will be used for oncocytic ACC) OR
    ii) biopsy results compatible with ACC in the context of clinical setting highly sugges-tive of ACC (adrenal mass > 4 cm invading surrounding organs or associated with dis-tant metastases).
    3. Locally advanced or metastatic disease not amenable to surgery with curative intent with measurable disease per RECIST 1.1 37 as determined by the investigator based on an assessment of all known disease sites by computerized tomography (CT) scan or magnetic resonance imaging (MRI) of chest/abdomen/pelvis within 28 days before the first dose of cabozantinib
    4. Received prior treatment with mitotane and platinum containing chemotherapy. Pa-tients in whom mitotane and/or platinum containing chemotherapy is contraindicated or who refused treatment with mitotane and/or platinum containing chemotherapy are eligible for the study.
    5. Documented progressive disease.
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    7. Recovery to baseline or ≤ Grade 1 CTCAE v.5.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive ther-apy
    8. Life expectancy of at least 3 months
    9. Adequate organ and bone marrow function and laboratory values as follows within 14 days prior to the first dose of cabozantinib:
    a. Absolute neutrophil count (ANC) ≥ 1500/µL without colony stimulating factor support, white blood cell count ≥ 2500/µL.
    b. Platelets ≥ 100,000/µL without transfusion
    c. Hemoglobin ≥ 9 g/dL
    d. Bilirubin ≤ 1.5 × the upper limit of normal (ULN). For subjects with known Gil-bert’s disease, bilirubin ≤ 3.0 mg/dL
    e. Serum albumin ≥ 2.8 g/dl
    f. (PT)/INR or partial thromboplastin time (PTT) test < 1.3 x the laboratory ULN
    g. Serum creatinine ≤ 2.0 × ULN or creatinine clearance (CrCl) ≥ 30 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:
    Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72). Female: Multiply above result by 0.85
    h. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alka-line phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). In case of liver me-tastases ALT and AST ≤ 5.0 x ULN are acceptable. ALP ≤ 5 x ULN with doc-umented bone metastases.
    i. Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg), or 24-h urine protein ≤ 1 g
    10. Capable of understanding and complying with the protocol requirements .
    11. Women of childbearing potential* must have a negative pregnancy test at screening. Additional pregnancy testing will be performed in WOCBP at monthly intervals. Pa-tients of reproductive potential (men and women) must agree to use highly effective methods of contraception** during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used.
    12. Able to give written informed consent
    E.4Principal exclusion criteria
    A subject who meets any of the following criteria is ineligible for the study:
    1. Received cytotoxic chemotherapy, or targeted therapy (including investigational cyto-toxic chemotherapy) or biologic agents (e.g., cytokines or antibodies), or other investi-gational agent within 14 days before study treatment.
    2. Treatment with mitotane <28 days prior study inclusion OR mitotane serum/plasma concentration documented of ≥2 mg/L at screening. Up to 5 mg/L are acceptable with Sponsor approval.
    3. Prior treatment with cabozantinib or other cMET inhibitors
    4. Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radi-onuclide treatment (eg, I-131 or Y-90) within 6 weeks before first dose of study treat-ment. Subject is excluded if there are any clinically relevant ongoing complications from prior radiation therapy.
    5. Known brain metastases or cranial epidural disease unless adequately treated with ra-diotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery be-fore first dose of study treatment. Eligible subjects must be neurologically asympto-matic and without corticosteroid treatment at the time of first dose of study treatment. Corticosteroid replacement treatment is allowed with dose at the discretion of the in-vestigator.
    6. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin in-hibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
    a. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
    b. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
    7. The use of strong CYP3A4 inhibitors (with the exception of ketoconazole).
    8. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
    a. Cardiovascular disorders:
    i. Congestive heart failure New York Heart Association Class 3 or 4, un-stable angina pectoris, serious cardiac arrhythmias.
    ii. Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihyper-tensive treatment.
    iii. Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep ve-nous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.
    Note: Subjects with a diagnosis of incidental, subsegmental PE or deep vein thrombosis (DVT) or other large vessel thrombosis within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.
    b. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
    i. The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn’s disease), di-verticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
    ii. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.
    Note: Complete healing of an intra-abdominal abscess must be con-firmed before first dose of study treatment.
    9. Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
    10. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease mani-festation.
    11. Lesions invading or encasing any major blood vessels. In subjects with liver metasta-ses and lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint: To estimate progression free survival at 4 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks after treatment initiation
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • overall survival
    • Best Objective Response Rate (ORR)
    • duration of response (DR)
    • progression-free survival
    • best percentage change in size of target lesions
    • incidence and severity of adverse events possibly related to cabozantinib graded according to CTC-AE 5.0
    • quality of life by EORTC QLQ-C30
    Exploratory Endpoints
    • To explore the relationship between cabozantinib pharmacokinetics and treatment re-sponse and tolerability
    • To study steroid hormone biomarkers and targeted metabolomics as markers of disease response.
    • To study the effect of cabozantinib on immune markers by obtaining blood samples collection at baseline, during therapy and at time of progression.
    • To explore the relation between pharmacogenetic variants and cabozantinib pharmacokinetics.
    • In archival formalin-fixed paraffin-embedded tumor material: To determine c-MET copy number (FISH), mutations (incl. Delta Exon14), c-MET mRNA expression (RNAscope) and VEGFR2 expression (IHC) as markers of response
    • In patients in whom fresh tumor material is available: To characterize the major immune cell types (T cells, B cells, NK cells, DC), T cell differentiation status and functionality (IFNgamma, TNFalpha, GB) and expression levels of costimulatory and coinhibitory molecules on T cells and their respective receptors such as PD-L1 on infiltrating myeloid cells and tumor cells and determine tumor neoantigens by exome sequencing
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy analyses will be performed for each of the response criteria as well as for overall and progression free survival using the full analysis set for the primary analysis and, for secondary analyses, the per-protocol set.

    A categorical efficacy variable will be computed identifying the patient status at each visit by one of the categories CR, PR, SD or PD.
    The best response will be defined as a unique categorical variable (categories CR, PR, SD and PD) for each patient.
    The overall survival (OS) will be handled as time to event variable.
    Duration of CR, PR and PFS will be also handled as time to event variables and calculated analogously to OS.
    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 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 No
    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.8.3 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 concerned2
    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 years5
    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: 37
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state37
    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)
    After end of participation in the trial the patients will be treated per standard of care.
    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 Decision2019-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 00:04:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA