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    EudraCT Number:2017-003667-35
    Sponsor's Protocol Code Number:GBG-97-AMICA
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2017-003667-35
    A.3Full title of the trial
    Anti-hormonal maintenance treatment with the CDK4/6 inhibitor Ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial
    Antihormonelle Erhaltungstherapie nach First-Line-Chemotherapie mit dem CDK4/6-Inhibitor Ribociclib bei Hormonrezeptor-positivem / HER2-negativem, metastasiertem Brustkrebs: Eine Phase-II-Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anti-hormonal Therapy with Ribociclib in HR-positive / HER2-negative metastatic breast cancer.
    Antihormontherapie mit Ribociclib bei Hormonrezeptor-positivem / HER2-negativem metastasiertem Brustkrebs.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberGBG-97-AMICA
    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 SponsorGBG Forschungs GmbH
    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 supportNovartis Pharma GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGBG Forschungs GmbH
    B.5.2Functional name of contact pointAMICA
    B.5.3 Address:
    B.5.3.1Street AddressDornhofstraße 10
    B.5.3.2Town/ cityNeu-Isenburg
    B.5.3.3Post code63263
    B.5.4Telephone number+49610274800
    B.5.5Fax number+4961027480440
    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. name Kisqali 200 mg
    D. of the Marketing Authorisation holderNovartis Europharm 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.3.1Product nameRibociclib
    D.3.4Pharmaceutical form Film-coated 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 INNRIBOCICLIB
    D.3.9.4EV Substance CodeSUB180246
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    HR-positive/HER2-negative metastatic breast cancer.
    Hormonrezeptor-positiver/HER2-negativer metastasierter Brustkrebs
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer
    Metastasierter Brustkrebs
    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
    To estimate the median PFS with 95% confidence interval (CI) of an anti-hormonal maintenance therapy after 1st line chemotherapy at the discretion of the investigator (e.g. taxanes, capecitabine, vinorelbine, anthracycline) with the CDK4/6 inhibitor ribociclib.
    Bestimmung des mittleren PFS mit einem 95% -Konfidenzintervall (CI) einer antihormonellen Erhaltungstherapie nach first-line Chemotherapie nach Wahl des Arztes (z. B. Taxane, Capecitabin, Vinorelbin, Anthracyclin) mit dem CDK4 / 6-Inhibitor Ribociclib.
    E.2.2Secondary objectives of the trial
    - To determine the overall survival rate at seven months
    - To describe safety, treatment compliance and clinical
    benefit rate
    - To evaluate patient reported outcomes
    - Auswertung des Einflusses auf das Gesamtüberleben und die Klinische Benefitrate (CBR-Clinical Benefit Rate)
    - Vergleich der Sicherheit zwischen den beiden Armen
    - Vergleich der Compliance zwischen den beiden Armen
    - Auswertung der Patient Reported Outcomes

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
    2. Female patients.
    3. Age ≥ 18 years old.
    4. Histologically confirmed HER2-/HR+ locally advanced or metastatic invasive breast carcinoma assessed on the primary tumor and/or on the metastatic lesions (preferred).
    5. Willingness and ability to provide archived formalin fixed paraffin embedded tissue block or a partial block from primary surgery and/or tumor or metastasis biopsy, which will be used for further breast cancer research.
    6. Maintenance endocrine therapy could have already been started up to 6 weeks before enrolment, but after achievement of tumor response or stable disease.
    7. Maintenance therapy must be preceded prior to enrolment by at least 4 cycles of a mono- or polychemotherapy. Tumor response or stable disease needs to be maintained to allow entry into the trial. Study treatment must start within 8 weeks of the last dose of chemotherapy.
    8. Previous therapy with maximum one line of anti-hormonal treatment is allowed.
    9. Previous neoadjuvant/adjuvant therapy is allowed. In case of cancer other than breast cancer, treatment should be completed more than 5 years before study entry.
    10. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
    11. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.03 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
    12. The patient must be accessible for scheduled visits, treatment and follow-up. Patients registered on this trial must be treated at the participating center which could be the Principal or a Co- investigator’s site.
    13. Life-expectancy > 6 months.
    14. The subjects need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) or B) childbearing potential with negative urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive).
    1. Schriftliches Einverständnis vor Beginn jeglicher studienspezifischer Untersuchungen nach lokal gültigen, regulatorischen Richtlinien. Dieses muss die Zustimmung zur erwarteten Kooperation der Patientin zu der Therapie und der Nachverfolg enthalten.
    2. Weibliche Patientinnen.
    3. Alter ≥ 18 Jahre.
    4. Histologisch gesicherter HER2-negativer, Hormonrezeptor-positiver lokal fortgeschrittener oder metastasierter Brustkrebs. Der Rezeptorstatus kann am Primärtumor und/oder an einer Metastase (bevorzugt) erhoben werden.
    5. Bereitschaft und Fähigkeit ein formalinfixiertes, in Paraffin eingebettetes Gewebe (FFPE) oder Teil-Gewebe der primären Operation des Tumors und/oder der Biopsie des Tumors oder der Metastase zur Verfügung zu stellen. Dies wird für weitere Forschungsprojekte im Rahmen der Brustkrebsforschung verwendet.
    6. Antihormonelle Erhaltungstherapie angewendet nach Stabilisierung der Erkrankung bzw. Tumorresponse nach Chemotherapie begonnen bis zu 6 Wochen vor Einschluß.
    7. Mindestens 4 Zyklen einer Mono- oder Polychemotherapie, die der Erhaltungstherapie vorausgegangen sein müssen. Eine Stabilisierung der Erkrankung bzw. ein Tumoransprechen unter Chemotherapie ist eine Voraussetzung, um an der Studie teilnehmen zu können. Die erste Gabe der Studienmedikation muss innerhalb von 8 Wochen nach Abschluss des letzten Chemotherapie-Zyklus erfolgen Eine vorangegangene Therapie mit maximal einer antihormonellen Therapie für metastasierten Brustkrebs ist erlaubt.
    8. Eine vorangegangene neoadjuvante/adjuvante Chemotherapie für Brustkrebs ist erlaubt. Falls eine Therapie im Rahmen eines anderen Karzinoms erfolgte, so muss diese Therapie vor 5 Jahren abgeschlossen worden sein.
    9. Eastern Cooperative Oncology Group (ECOG) Performance-status (PS) 0-1.
    10. Erholung der Patientin von allen akuten Nebenwirkungen einer vorherigen Anti-Tumor-Therapie oder chirurgischer Eingriffe nach NCI CTCAE Version 4.03 Grad ≤ 1 (mit Ausnahme von Alopezie und Nebenwirkungen, die vom Prüfarzt als nicht sicherheitsrelevant eingestuft werden).
    11. Die Patientin muss für geplante Visiten, Behandlung und Follow-up zur Verfügung stehen. Patientinnen, die im Rahmen dieser Studie behandelt werden, müssen im teilnehmenden Zentrum behandelt werden (das Zentrum des PI oder eines Co-Investigators).
    12. Lebenserwartung > 6 Monate.
    13. Die Patientinnen müssen entweder
    A) nicht gebärfähig sein (dokumentiert postmenopausal oder nach Hysterektomie) oder B) es muss bei gebärfähigen Frauen ein negativer Schwangerschaftstest im Urin vorliegen (in diesem Fall müssen die Patientinnen ein hochwirksames nicht-hormonelles Verhütungsmittel benutzen).
    E.4Principal exclusion criteria
    1. Uncontrolled/untreated central nervous system lesions.
    2. Known severe hypersensitivity reactions to compounds similar to one of the investigational and supportive treatment.
    3. Inadequate organ function immediate prior to randomization including:
    - Hemoglobin < 10 g/dL
    - Absolute neutrophil count (ANC) < 2000/mm³ (< 2.0 x 109/L)
    - Platelets < 100,000/mm³ (< 100 x 109/L)
    - Alanine aminotransferase (ALAT/SGPT) and/or aspartate aminotransferase (ASAT/SGOT) > 2.0 x upper normal limits (ULN)
    - Alkaline phosphatase (ALP) > 2.5 x ULN
    - Total serum bilirubin > 1.5 x ULN
    - Serum creatinine >1.5 x ULN or estimated creatinine clearance < 60 mL/min as calculated using the method standard for the institution
    4. Severe and relevant comorbidity that would interact with the participation in the study.
    5. Previous malignant disease being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer).
    6. Evidence for active infection including wound infections, HIV, hepatitis.
    7. QTc >450 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
    8. Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (i.e. hypocalcemia, hypokalemia, hypomagnesemia).
    9. Any of the following within 6 months prior to enrolment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.03 grade ≥ 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
    10. Other severe acute, uncontrolled or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    11. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
    12. Patients treated within the last 7 days prior to enrolment with drugs known to be CYP3A4 inhibitors or inducers (see section 11.4) or drugs that are known to prolong the QT interval.
    13. Pregnant and lactating women.
    1. Unkontrollierte/unbehandelte Metastasierung im ZNS.
    2. Bekannte schwere Überempfindlichkeitsreaktionen gegen ein in der Studie verwendetes Medikament ( Studienmedikament sowie supportive Therapie).
    3. Unzureichende Organfunktion vor der Randomisierung:
    - Hämoglobin < 10 g/dL
    - Neutrophile (ANC) < 2000/mm³ (< 2.0 x 109/L)
    - Thrombozyten < 100,000/mm³ (< 100 x 109/L)
    - Alaninaminotransferase (ALAT) und/oder Aspartat transaminase (ASAT) > 2.0 x oberer Normalwert
    - Alkalische Phosphatase (ALP) > 2.5 x oberer Normalwert
    - Gesamt-Bilirubin > 1.5 x oberer Normalwert
    - Kreatinin >1.5 x oberer Normalwert oder geschätzte Kreatinin-Clearance <60 mL / min, berechnet nach dem lokalen Methodenstandard
    4. Starke und relevante Co-Morbidität, die die Teilnahme an der Studie beeinflussen könnte.
    5. Frühere Krebserkrankung mit einem krankheitsfreien Intervall von weniger als 5 Jahren Krankheitsfreiheit (ausgenommen CIS der Cervix und nicht-melanomatöser Karzinom der Haut).
    6. Eine nachgewiesene aktive Infektion einschließlich Wundinfektionen, HIV und Hepatitis.
    7. QTc> 450 ms oder eine familiäre oder persönliche Vorgeschichte eines langen oder kurzen QT-Syndroms, Brugada-Syndroms oder bekannte Vorgeschichte einer QTc-Verlängerung oder Torsade de Pointes.
    8. Unkontrollierte Elektrolytstörungen, die die Wirkungen eines QTc-verlängerten Arzneimittels (d.h. Hypokalzämie, Hypokaliämie, Hypomagnesiämie) beeinflussen können.
    9. Eine der folgenden Erkrankungen innerhalb von 6 Monaten vor der Randomisierung: Myokardinfarkt, schwere/instabile Angina pectoris, persistierende Herzarrhythmien von Grad≥ 2 (NCI CTCAE Version 4.3), Vorhofflimmern jeglicher Art, Z.n. koronarer oder peripherer Bypass-Op, symptomatische kongestive Herzinsuffizienz, zerebrovaskuläre Erkrankung einschließlich einer transischämischen Attacke (TIA) oder einer symptomatischen Lungenembolie.
    10. Andere schwere akute, unkontrollierte oder chronische Erkrankungen, psychiatrische Erkrankungen oder Laboranomalien, die das Risiko, welches mit der Studienteilnahme bzw. mit der Einnahme der Studienmedikation verbunden ist, erhöhen oder die die Interpretation der Studienergebnisse beeinflussen können sowie die nach Meinung des Prüfarztes, die Patientin für die Studie ungeeignet erscheinen lassen.
    11. Gleichzeitige Behandlung mit anderen experimentellen Medikamenten oder Teilnahme an einer anderen klinischen Studie mit jeglichem nicht vermarkteten Studienmedikament innerhalb von 30 Tagen vor dem Einschluss in die Studie.
    12. Patienten, die innerhalb der letzten 7 Tage vor der Randomisierung mit Arzneimitteln behandelt wurden, die als CYP3A4-Inhibitoren oder Induktoren bekannt sind (siehe Abschnitt 11.4) oder Medikamente, von denen bekannt ist, dass sie das QT-Intervall verlängern.
    13. Schwangere und stillende Frauen.
    E.5 End points
    E.5.1Primary end point(s)
    Locally-assessed progression-free survival (PFS) defined as the time elapsed between enrolment and tumor progression or death from any cause.
    Lokal beurteiltes progressionsfreie Überleben (PFS), definiert als die Zeitdauer zwischen dem Einschluß und der Tumorprogression bzw. dem Tod aufgrund jeglicher Ursache.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 months after last subject enrolled (after end of study)
    7 Monate nach dem Einschluß der letzten Patientin (nach dem Studienende)
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    - Overall survival (OS) defined as the time elapsed between treatment enrolment and death from any cause
    - Clinical benefit rate (CBR) defined as the proportion of subjects with best response of complete response, partial response, or stable disease for at least 24 weeks.

    Safety will be assessed on the basis of adverse events, serious adverse events and adverse events of special interest. Safety by toxicity grades is defined by the NCI-CTCAE version 4.03.

    Compliance will be assessed on the basis of treatment reductions, interruptions and permanent discontinuations with reasons.

    Quality of life (QoL) will be assessed using the General Quality of Life questionnaire (FACT-B), which will be filled in at study entry and every three month thereafter.
    - Gesamtüberleben (OS), definiert als die Zeitdauer zwischen dem Einschluß und dem Tod der Patientin aufgrund jeglicher Ursache.
    - Klinische Benefitrate (CBR), definiert als der Anteil der Patientinnen mit dem besten Ansprechen, also einer complete response, partial response oder einer stable disease, für mindestens 24 Wochen.

    Die Sicherheit wird auf der Grundlage von unerwünschten Ereignissen, schwerwiegenden unerwünschten Ereignissen und unerwünschten Ereignissen von besonderem Interesse bewertet. Der Grad der Toxizität wird durch die NCI-CTCAE Version 4.03 definiert.

    Die Compliance wird auf der Grundlage von Dosisreduktionen, Unterbrechungen und permanenten Abbrüchen der Studienmedikation und deren Gründen beurteilt.

    Die Lebensqualität (QoL) wird mit dem Fragebogen "General Quality of Life" (FACT-B) beurteilt, welcher zu Beginn der Studie und anschließend alle drei Monate von den Patientinnen ausgefüllt wird.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints, will be assessed at the same timepoints as the primary endpoint.
    Alle sekundären Endpunkte werden zum selben Zeitpunkt wie das
    primäre Endpunkt ausgewertet.
    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. 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Antihormontherapie: Anastrozol, Letrozol, Exemestan, Fulvestrant.
    Anti-hormonal therapy: anastrozole, letrozole, exemestane, fulvestrant.
    E.8.2.4Number of treatment arms in the trial1
    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 concerned30
    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
    7 months after enrolling of last Patient.
    7 Monate nach dem Einschluß der letzten Patientin.
    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 months4
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 state95
    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)
    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 Decision2017-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-20
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