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    Summary
    EudraCT Number:2020-002079-36
    Sponsor's Protocol Code Number:73750
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-002079-36
    A.3Full title of the trial
    TGF-β And PDL-1 inhibition with Bintrafusp alfa in Esophageal Squamous Cell carcinoma combined with chemoradiation TheRapY (TAPESTRY)
    TGF-β en PDL-1 blokkade met Bintrafusp alfa in plaveiselcelcarcinoom van de slokdarm in combinatie met chemoradiotherapie (TAPESTRY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Feasability study for treatment with definitive chemoradiotherapy and bintrafusp alfa for patients with esophageal cancer (TAPESTRY)
    Haalbaarheidsonderzoek naar de behandeling van definitieve chemoradiotherapie en bintrafusp alfa bij patiënten met slokdarmkanker (TAPESTRY)
    A.3.2Name or abbreviated title of the trial where available
    TAPESTRY
    TAPESTRT
    A.4.1Sponsor's protocol code number73750
    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 SponsorAmsterdam University Medical Centers
    B.1.3.4CountryNetherlands
    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 supportAmsterdam University Medical Centers
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam University Medical Centers
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialmedonc@amc.uva.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namebintrafusp alfa
    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 INNBINTRAFUSP ALFA
    D.3.9.2Current sponsor codeM7824
    D.3.9.4EV Substance CodeSUB193581
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2400
    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 RoleComparator
    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 Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 for solution for injection/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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameCarboplatin
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 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
    Esophageal squamous cell carcinoma
    Plaveiselcelcarcinoom van de oesofagus
    E.1.1.1Medical condition in easily understood language
    esophageal cancer
    slokdarmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the feasibility of bintrafusp alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in terms of completion of treatment with bintrafusp alfa of patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.
    Het primaire doel van de studie is de haalbaarheid evalueren van bintrafusp alfa gecombineerd met definitieve chemoradiotherapie (carboplatin, paclitaxel en radiotherapie). Hierbij wordt gekeken naar het aandeel patienten met plaveiselcelcarcinoom van de slokdarm of slokdarm-maagovergang dat de behandeling volledig afrondt.
    E.2.2Secondary objectives of the trial
    1. Incidence and severity of toxicity defined according to CTCAE v5 and Radiation Oncology Group (RTOG) criteria.
    2. Safety of bintrafusp alfa in combination with definitive chemoradiotherapy
    3. Percentage completion of chemotherapy and radiation treatment
    4. Percentage withdrawal rate from chemoradiation due to bintrafusp alfa related complications
    5. Infield locoregional progression free survival
    6. Any progression free survival
    7. Overall survival
    8. Quality of life, with a special focus on dysphagia
    1. Incidentie en ernst van toxiciteit, gedefinieerd volgens de CTCAE v5 en RTOG criteria.
    2. Veiligheid van bintrafusp alfa in combinatie met definitieve chemoradiotherpie
    3. Percentage patienten dat chemotherapie en radiotherapie behandeling.
    4. Percentage patienten dat de behandeling onderbreekt ivm bintrafusp alfa gerelateerde complicaties.
    5. Locoregionale (binnen het bestralingsveld) progressievrije overleving.
    6. Progressievrije overleving
    7. Overleving
    8. Qualiteit van leven, met speciale aandacht voor dysfagie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically proven squamous cell carcinoma of the esophagus or gastro esophageal junction.
    - Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen. Patients with M1 disease solely on the basis of supraclavicular metastasis are eligible. Patients with resectable tumors refusing radical surgery or inoperable patients due to comorbidity are eligible.
    - Locoregional recurrences without distant metastasis after surgery alone or endoscopical resection
    - Locoregional recurrences without distant metastasis after neoadjuvant chemoradiation + resection or definitive chemoradiation outside the previously irradiated area, provided that full dose of radiation can safely be delivered.
    - Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible if all other criteria are fulfilled.
    - If the tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction.
    - Age ≥ 18.
    - ECOG performance status 0-2
    - Adequate hematological, renal and hepatic functions.
    - Written, voluntary informed consent
    - Patients must be accessible to management and follow-up in the treatment center
    - Histologisch bewezen plaveiselcelcarcinoom van de slokdarm of slokdarm-maag-overgang
    - Chirurgische resectie is niet mogelijk (T1-T4a, N0 of N+, M0), zoals bepaald met EUS, PET scan en diagnostische CT scan van hals, thorax en abdomen. Patiënten met M1 ziekte uitsluitend op basis van een supraclaviculaire metastase zijn geschikt voor deelname. Patiënten met resectabele tumoren die radicale chirurgie weigeren of patiënten die vanwege comorbiditeit niet operabel zijn, zijn geschikt.
    - Locoregionale recidieven zonder metastasen op afstand na uitsluitend chirurgie of endoscopische resectie.
    - Locoregionale recidieven zonder metastasen op afstand na neoadjuvante chemoradiatie en resectie of definitieve chemoradiatie buiten het eerdere bestralingsveld, op voorwaarde dat de volledige bestralingsdosis veilig kan worden gegeven.
    - Tumoren die met de endoscoop niet kunnen worden gepasseerd voor endoscopische echografie zijn geschikt indien aan alle andere criteria wordt voldaan.
    - Indien de tumor tot onder de gastroesophageale (GE) overgang doorloopt tot in de proximale maag, ligt de bulk van de tumor in de slokdarm of op de GE overgang.
    - Leeftijd ≥ 18
    - ECOG performance status 0-2
    - Adequate hematologische, nier- en leverfuncties.
    - Geschreven, vrijwillig informed consent.
    - Patienten moeten bereikbaar zijn voor management en follow up in het behandelend centrum.
    E.4Principal exclusion criteria
    - Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
    - Patient with tracheo-esophageal fistula or extension into the mucosal layer of the trachea, highly at risk to develop fistula. Thus, tumor extension to the trachea is allowed, but not through the trachea.
    - Patient with aortal involvement with high risk of bleeding or developing a fistula.
    - Patients with pathological lymph nodes at both supraclavicular and truncus coeliacus level.
    - Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
    - Patient (male or female) in the reproductive age is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
    - Previous chemotherapy, radiation and/or treatment with checkpoint inhibitors for the currently present esophageal tumor.
    - Previous chemotherapy and/or treatment with targeted agents and/or checkpoint inhibitors for other forms of cancer within the last six months.
    - Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor.
    - Presence of an esophageal stent.
    - History of bleeding diathesis or major bleeding event (grade ≥ 2) in the month prior to first dose of trial treatment.
    - Clinically significant cardiovascular disease precluding safe treatment with chemoradiation.
    - Evidence of pulmonary fibrosis and/or clinically significant impairment of lung function precluding safe treatment with chemoradiation. In case of doubt about pulmonary function, a lung function test should be performed and, in case of abnormalities, discussed with the principle investigator.
    - Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide or cyclosporine.
    - Mental status that would prohibit the understanding and giving of informed consent.
    - Inadequate caloric- and/or fluid intake despite consultation of a dietician and/or tube feeding.
    - Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine for patients with a history of autoimmune-related hypothyroidism, insulin for patients with type 1 diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo with dermatological manifestations only are eligible to enter the study.
    - Diagnosis of HIV unless stable on antiretroviral therapy for at least 4 weeks, no evidence of multi-drug resistance, viral load of < 400 copies/ml and CD4+ T-cells ≥ 350 cells/µl.
    - Active HBV/HCV. Participants on a stable dose of antiviral therapy with HBV/HCV viral load below the limit of quantification are eligible.
    - A diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    - Evidence of interstitial lung disease or active, non-infectious pneumonitis.
    - An active infection requiring systemic therapy, which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
    - Administration of a live vaccine within 30 days prior to the first dose of trial treatment. Seasonal flu vaccines that do not contain a live virus are permitted.
    - Patients with prior allogeneic stem cell or solid organ transplantation.
    - Maligniteit op dit moment of in het verleden, anders dan de slokdarmkanker waarvan de prognose interfereert met de slokdarmkanker.
    - Tracheo-oesofageale fistel of uitbreiding tot in de mucosa van de trachea met hoog risico op fisteling. Tumor uitbreiding tot in de trachea is toegestaan, maar niet door de trachea.
    - Betrokkenheid van de aorta met hoog risico op bloeding of fisteling.
    - Pathologische lymfeklieren zowel supraclaviculair als op het level van de truncus coeliacus.
    - zwangerschap, geplande zwangerschap of borstvoeding.
    - Patienten in de reproductieve fase die niet bereid zijn om effectieve anticonceptiemethoden te gebruiken tijdens de behandeling en 6 maanden daarna.
    - Eerdere behandeling met chemotherapie, radiotherapie en/of immuuntherapie voor de slokdarmkanker.
    - Eerdere behandeling met chemotherapy en/of immuuntherapie en/of targeted therapy voor andere maligniteiten, minder dan 6 maanden geleden.
    - Eerdere bestraling van het mediastinum waardoor volledige bestralingsdosis voor de slokdarmkanker niet kan worden gegeven.
    - Aanwezigheid van een slokdarmstent
    - Aanwijzingen voor stollingsproblematiek of grote bloeding (graad ≥2) in de maand voor de eerste studiebehandeling.
    - Klinisch significant cardiovasculair lijden waardoor chemoradiatie niet veilig gegeven kan worden.
    - Aanwijzingen voor longfibrose en/of klinisch relevante vermindering van de longfunctie waardoor chemoradiatie niet veilig kan worden gegeven.
    - Serieuze onderliggende medische aandoening waardoor de patient de geplande behandeling niet veilig kan ondergaan, inclusief eerdere allergische reacties op medicatie met cremophor zoals teniposide of cyclosporine.
    - Mentale status die informed consent onmogelijk maakt.
    - Inadequate calorische- en/of vocht inname ondanks consultatie van een dietist en/of sondevoeding.
    - Actieve autoimmuunziekte die systemische behandeling behoeft in de afgelopen 2 jaar. Substitutietherapie wordt niet gezien als vorm van systemische behandeling. Patienten met vitiligo met uitsluitend dermatologische manifestaties zijn geschikt voor deelname aan de studie.
    - Diagnose van HIV, tenzij stabiel op antiretrovirale therapie voor minimaal 4 weken, geen aanwijzingen voor therapieresistentie, viral load of <400 kopieën/ml en CD4+ Tcellen ≥350 cellen/uL.
    Actieve HBV of HCV infectie. Patiënten die een stabiele dosis antivirale therapie gebruiken en een viral load beneden detectieniveau hebben zijn geschikt voor deelname.
    - Diagnose van immunodeficiëntie of behandeld worden met systemische corticosteroiden (≥10mg/dag prednison of equivalent) of enige andere vorm van immuunsuppresieve therapie in de 7 dagen voorafgaand aan start van de studiebehandeling.
    - Aanwijzingen voor interstitiele longziekten of actieve, non-infectieuze pneumonitis.
    - Actieve infectie waarvoor systemische behandeling nodig is, die niet verholpen is 3 (simpele infectie zoals cystitis) tot 7 (ernstige infectie zoals pyelonefritis) dagen voorafgaand aan start van de studiebehandeling.
    - Vaccinatie met een levend vaccin in de 30 dagen voorafgaand aan de start van de studiebehandeling. Griepvaccinaties zonder levend pathogeen zijn toegestaan.
    - Patienten die eerder een allogene stamcel- of orgaantransplantatie hebben ondergaan.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is feasibility defined as percentage of patients that complets at least two of the three planned cylces of bintrafusp alfa.
    Primair eindpunt is de haalbaarheid, gedefineerd als percentage patienten dat minimaal twee van de drie geplande cycli met bintrafusp alfa afrond.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After last treatment cycle
    Na de laatste behandeling
    E.5.2Secondary end point(s)
    1. Incidence and severity of toxicity defined according to CTCAE v5 and Radiation Oncology Group (RTOG) criteria.
    2. Safety of bintrafusp alfa in combination with definitive chemoradiotherapy
    3. Percentage completion of chemotherapy and radiation treatment
    4. Percentage withdrawal rate from chemoradiation due to bintrafusp alfa related complications
    5. Infield locoregional progression free survival
    6. Any progression free survival
    7. Overall survival
    8. Quality of life, with a special focus on dysphagia
    1. Incidentie en ernst van toxiciteit, gedefinieerd volgens de CTCAE v5 en RTOG criteria.
    2. Veiligheid van bintrafusp alfa in combinatie met definitieve chemoradiotherpie
    3. Percentage patienten dat chemotherapie en radiotherapie behandeling.
    4. Percentage patienten dat de behandeling onderbreekt ivm bintrafusp alfa gerelateerde complicaties.
    5. Locoregionale (binnen het bestralingsveld) progressievrije overleving.
    6. Progressievrije overleving
    7. Overleving
    8. Qualiteit van leven, met speciale aandacht voor dysfagie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment and one week after treatment. Follow up data will be collected following standard follow up visits.
    Tijdens behandeling en een week na behandeling. Follow up data wordt verzameld gedurende reguliere controles.
    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) 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 Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject
    laatste bezoek van de laatste patient.
    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 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state49
    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
    geen
    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 Decision2020-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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