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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2020-004938-38
    Sponsor's Protocol Code Number:ADVANCE2020
    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:2021-08-27
    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 number2020-004938-38
    A.3Full title of the trial
    ADVANCE: A phase II single-arm, open-label study of Atezolizumab and Derazantinib for patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements
    ADVANCE: Eine einarmige, offene klinische Studie der Phase II zur Behandlung mit Atezolizumab und Derazantinib bei Patienten mit einem fortgeschrittenen intrahepatischen Cholangiokarzinom, das molekulare FGFR2 Alterationen (Gen-Fusionen/Rearrangements) aufweist
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ADVANCE: A clinical study of Atezolizumab and Derazantinib for patients with advanced intrahepatic cholangiocarcinoma with gene FGFR2 fusions/rearrangements
    Die ADVANCE Studie: Eine einarmige, offene klinische Studie der Phase II zur Behandlung mit Atezolizumab und Derazantinib bei Patienten mit einem fortge-schrittenen intrahepatischen Cholangiokarzinom, das molekulare FGFR2 Alterationen (Gen-Fusionen/Rearrangements) aufweist
    A.4.1Sponsor's protocol code numberADVANCE2020
    A.5.4Other Identifiers
    Name:AIO Study NumberNumber:AIO-HEP-0221/ass
    Name:Roche CodeNumber:ML42597
    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 SponsorFrankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    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 supportROCHE Pharma AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBasilea Pharmaceutica International Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFrankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressSteinbacher Hohl 2-26
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60488
    B.5.3.4CountryGermany
    B.5.4Telephone number+496976014420
    B.5.5Fax number+496976013655
    B.5.6E-mailADVANCE@ikf-khnw.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 Tecentriq® 1.200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 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 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 nameDerazantinib
    D.3.2Product code Derazantinib•2HCl / BAL087 / BAL0000087-001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 non-resectable intrahepatic cholangiocarcinoma with positively confirmed FGFR2 fusion/rearrangements via NGS-Analysis
    E.1.1.1Medical condition in easily understood language
    Advanced and inoperable intrahepatic bile duct cancer with positively confirmed FGFR2 genetic alterations
    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 PT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.1
    E.1.2Level LLT
    E.1.2Classification code 10008594
    E.1.2Term Cholangiocarcinoma non-resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077846
    E.1.2Term Cholangiocarcinoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective of the study is to assess the efficacy of atezolizumab in combination with derazantinib by ORR (Objective Response Rate) after 9 months of study treatment as assessed by the local investigator according to RECIST 1.1 criteria.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of atezolizumab in combination with derazantinib by ORR (Objective Response Rate) at EOT (End Of Treatment), PFSR (Progression Free Survival Rate) at 6, 8 and 10 months, PFS (Progression Free Survival) and OS (Overall Survival)
    - To evaluate the safety and tolerability of atezolizumab in combination with derazantinib
    - To evaluate biomarkers in tumor tissue and blood samples for their predictive and prognostic potential
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria to be eligible for the study:
    1. Fully informed written consent and locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
    2. Patients*, age ≥ 18 years at the time of signing the Informed Consent Form.
    3. Histologically documented diagnosis of non-resectable iCCA with positively confirmed FGFR2 fusion/rearrangement via NGS-Analysis.
    Note: Only CE-IVD marked NGS-tests are applicable which cover FGFR2 fusions and rearrangements.
    4. Performance status (PS) ≤ 2 (ECOG scale).
    5. At maximum one previous line of systemic anti-cancer therapy, (chemotherapy, hormonal, targeted therapy, experimental therapy) for which treatment was discontinued at least 4 weeks before the first dose of study treatment, or five half-lives of the respective anti-cancer therapy, whichever is the longer period.
    Note: For mABs in previous therapy the restriction to five half-lives does not apply.
    6. No prior treatment with any FGFR or immune checkpoint inhibitor (including but not limited to antiCTLA-4, antiPD-1, and antiPD-L1 therapeutic antibodies) apart from Durvalumab as PD-L1 inhibitor in first line therapy.
    7. Body weight > 30 kg AND BMI ≥ 15.
    8. At least one measurable site of disease as defined by RECIST 1.1 criteria.
    9. Adequate bone marrow and renal function including the following:
    Hemoglobin ≥ 9.0 g/dL (previous transfusion permitted); Absolute neutrophil count (ANC) ≥ 1.500 per µL (1.5×109/L); Platelet count ≥ 75,000 per µL (75 × 109/L);International normalized ratio (INR) between 0.8 × ULN to 1.0 × ULN OR ≤ 3 × ULN for subjects receving anticoagulant therapy
    Creatinine ≤ 1.5 × ULN OR CLCR ≥ 50 mL/min (as calculated by the Cockcroft-Gault formula);serum phosphate ≤ ULN;corrected serum calcium ≥ 1.75 mmol/L (≥ 7.0 mg/dL) AND ≤ 3.1 mmol/L (≤ 12.5 mg/dL); serum sodium ≥ LLN.
    10. Adequate hepatic function (with stenting for any obstruction, if required) including the following:Total bilirubin ≤ 2 × ULN; AST or ALT ≤ 3 × ULN (or ≤ 5 × ULN for subjects with liver metastases); Prothrombin time ≥ 60%; Albumin ≥ 2.8 g/dL.
    11. For patients with active hepatitis B virus (HBV):
    HBV DNA ≤ 500 IU/mL obtained within 28 days prior to initiation of study treatment, AND Anti-HBV treatment (per local standard of care; e.g., entecavir) prior to study entry and willingness to continue treatment for the length of the study.
    12. For patients with active hepatitis C virus (HCV):
    • Patients positive for hepatitis C virus (HCV) antibody are eligible, also if polymerase chain reaction testing is positive for HCV ribonucleic acid (RNA).
    • However, anti-viral therapy against HCV is only allowed prior to trial but not during the trial.
    13. Negative HIV test.
    14. Negative pregnancy test within 72 h prior to dosing.
    15. Females of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months or for a period of at least 5 half-lives of the respective drug/IMP (whichever is longer) after the last study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (has not had ≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
    16. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of 1% per year from screening to 5 months after the last dose of combination therapy or for a period of at least 5 half-lives of the respective drug/IMP after the last dose of combination therapy (whichever is longer). Men must refrain from donating sperm during this same period. Men with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy to avoid exposing the embryo.
    17. The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
    18. Must have a life expectancy of at least 12 weeks.
    E.4Principal exclusion criteria
    1. Mixed CCA and HCC.
    2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) study or a study without a medical intervention (specifically the PLATON registry [ClinicalTrials.gov identifier: NCT04484636] is allowed).
    3. Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery.
    4. Uncontrolled intercurrent illness (as described in the study protocol).
    5. History of another primary malignancy (with a few exceptions, as described in the study protocol).
    6. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 5 months after the last dose of combination therapy or for a period of at least 5 half-lives of the respective drug/IMP after the last dose of combination therapy (whichever is longer).
    7. Known allergy or hypersensitivity to any of the IMPs or any of the constituents of the product.
    8. Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the patient’s participation in the study.
    9. Active or History of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
    10. History of non-infectious pneumonitis requiring steroids, or patients with Grade ≥ 2 pneumonitis.
    11. History of active primary immunodeficiency.
    12. History of allogeneic bone marrow transplantation or prior solid organ transplantation.
    13. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment (with two exceptions, as described in the study protocol).
    14. Administration of a live, attenuated vaccine within four weeks or for a period of at least 5 half-lives of the respective drug/IMP (whichever is longer) prior to start of enrollment, or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab.
    15. Significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmias, unstable angina, and/or concurrent and clinically significant abnormalities on electrocardiogram (ECG) at Screening, including QTcF > 450 ms for males or > 460 ms for females.
    16. Clinically significant valvular defect.
    17. Unable or unwilling to swallow the complete daily dose of derazantinib capsules.
    18. Clinically unstable central nervous system (CNS) metastases (to be eligible, subjects must have stable disease > 3 months, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and/or have CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications).
    19. Current evidence of clinically significant corneal or retinal disorder, including but not limited to bullous/band keratopathy, keratoconjunctivitis (except for keratoconjunctivits sicca), corneal abrasion (except if related to trauma), inflammation/ulceration, confirmed by ophthalmologic examination.
    20. Significant gastrointestinal disorder(s) that could, in the opinion of the Investigator, interfere with the absorption, metabolism, or excretion of derazantinib and/or atezolizumab (e.g., Crohn’s disease, ulcerative colitis, extensive gastric resection).
    21. Active tuberculosis.
    22. Co-infection with hepatitis B and hepatitis C. Patients who are negative for HCV RNA will be considered non-infected for HCV.
    23. Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration.
    24. Treatment with strong CYP3A4 inducers within 14 days prior to initiation of study treatment, including rifampin (and its analogues) or St. John's wort.
    25. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
    26. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot make a rational/informed decision after receiving the study information [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) assessed every 8 weeks according to investigator-based RECIST 1.1 assessment, defined as the proportion of allocated subjects with best response of complete or partial response within 9 months after the date of first administration of study treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    E.5.2Secondary end point(s)
    - ORR (Objective Response Rate) at EOT (End of Treatment)
    - PFSR (Progression Free Survival Rate) at 6, 8 and 10 months
    - PFS (Progression Free Survival)
    - OS (Overall Survival)
    - Safety endpoints: incidence of adverse events, serious adverse events and adverse events of special interest; severity of adverse events by CTCAE v5.0 grade; relationship of adverse events to atezolizumab and/ or derazantinib; frequency of clinically significant abnormal laboratory parameters
    - Serum Tumor Markers (CA19-9, CEA) as efficacy measurements
    - Exploratory endpoints: fecal samples for microbiom analysis and blood samples for accompanying research project
    E.5.2.1Timepoint(s) of evaluation of this end point
    - End of study
    - Safety will be evaluated continuously and after end of study
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 concerned20
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state27
    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)
    None
    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 Decision2021-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-08
    P. End of Trial
    P.End of Trial StatusOngoing
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