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    Summary
    EudraCT Number:2020-001943-21
    Sponsor's Protocol Code Number:IFG-08-2019
    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:2020-12-29
    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 number2020-001943-21
    A.3Full title of the trial
    NeoOn – Neoadjuvant treatment of Ontruzant® (SB3) in patients with HER2-positive early breast cancer: An open-label, multicenter, phase IV study
    NeoOn – Neoadjuvante Behandlung von Patientinnen mit HER2-positivem Mammakarzinom mit Ontruzant®: eine offene, multizentrische Phase IV Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a trial for female patients diagnosed with early breast cancer who are planned to receive chemotherapy in combination with an anti-HER2 antibody before breast surgery. During this study all patients will receive a standard chemotherapy according to local in-house standard. Additionally all patients will receive the antibody Ontruzant®, a trastuzumab biosimilar. Only women with HER2 positive breast cancer will be allowed to participate in this study.
    Diese Studie richtet sich an Patientinnen, die an frühem HER2neu positiven Brustkrebs erkrankt sind und bei denen eine Chemotherapie in Kombination mit einem Antikörper gegen den HER2-Rezeptor vor der Operation geplant ist. Im Rahmen der Studie erhalten alle Patientinnen eine Standard-Chemotherapie, wie sie auch im Rahmen der klinischen Routine durchgeführt werden würde. Zusätzlich erhalten die Patientinen den Antikörper Ontruzant®. Ontruzant ist ein Trastuzumab-Biosimilar.
    A.3.2Name or abbreviated title of the trial where available
    NeoOn
    A.4.1Sponsor's protocol code numberIFG-08-2019
    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 SponsorInstitut für Frauengesundheit GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSamsung Bioepis Co, Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut für Frauengesundheit
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressUniversitätsstraße 21-23
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91045
    B.5.3.4CountryGermany
    B.5.4Telephone number004991319278968
    B.5.5Fax number004991319278953
    B.5.6E-mailneo.on@ifg-erlangen.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 Ontruzant
    D.2.1.1.2Name of the Marketing Authorisation holderSamsung Bioepis NL B.V.
    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 nameOntruzant
    D.3.4Pharmaceutical form Powder for 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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.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
    Female patients with early HER2positive breast cancer, neoadjuvantly treated.
    Patientinnen mit einem frühen HER2-positivem Mammakarzinom, die eine neoadjuvante Chemotherapie erhalten.
    E.1.1.1Medical condition in easily understood language
    Female patients with breast cancer who are treated with chemotherapy and an anti-HER2 antibody before final surgery. The breast cancer has to be positive for the HER2 receptor.
    Patientinnen mit frühem Brustkrebs, die vor ihrer Operation eine Chemotherapie in Kombination einem Antikörper gegen den HER2-Rezeptor erhalten sollen. Der Tumor muss HER2-Rezeptoren aufweisen.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    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 PT
    E.1.2Classification code 10006199
    E.1.2Term Breast cancer stage I
    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 PT
    E.1.2Classification code 10006200
    E.1.2Term Breast cancer stage II
    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 PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    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 10006188
    E.1.2Term Breast cancer female NOS
    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 10006192
    E.1.2Term Breast cancer NOS
    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 10006190
    E.1.2Term Breast cancer invasive NOS
    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 10021944
    E.1.2Term Infiltrating ductal breast cancer
    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 10006194
    E.1.2Term Breast cancer NOS stage I
    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 10006195
    E.1.2Term Breast cancer NOS stage II
    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 10006196
    E.1.2Term Breast cancer NOS stage III
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10021974
    E.1.2Term Inflammatory breast cancer
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER2 positive breast cancer
    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
    Pathological complete response (pCR) rate, defined as the complete absence of tumor cells (ypT0; ypN0) after neoadjuvant study treatment of HER2-positive early breast cancer patients treated with Ontruzant® (SB3).
    Häufigkeit pathologischer Komplettremission (pCR), definiert als vollständige Abwesenheit von Tumorzellen (ypT0; ypN0) nach neoadjuvanter Therapie mit Ontruzant® bei Patientinnen mit HER2-positiven Mammakarzinom.
    E.2.2Secondary objectives of the trial
    (1) To evaluate the pCR with other definitions of pCR (e.g. ypT0/is; ypN0)
    (2) To evaluate the safety and tolerability of Ontruzant®
    (3) Clinical response, as assessed by routine ultrasound or mammography
    (4)To assess the frequency of possible combination partners administered together with Ontruzant®
    (5) To evaluate changes in health related quality of life (QoL) assessments
    (1) Untersuchung von pCR nach anderen Definitionen (z.B. ypT0/is; ypN0)
    (2) Untersuchung der Sicherheit und Verträglichkeit von Ontruzant®
    (3) Beurteilung des klinischen Ansprechens, welches mittels Mamma-Sonographie und Mammographie untersucht wird
    (4) Untersuchung der Häufigkeit der Verabreichung von möglichen Kombinationstherapien mit Ontruzant®
    (5) Beurteilung der Veränderung der Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible for participation in this trial subject must fulfil all of the following criteria:
    1. Written informed consent prior to beginning of trial specific procedures.
    2. Subject must be female and aged ≥ 18 years on day of signing informed consent.
    3. ECOG 0-1.
    4. Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion.
    5. Measurable tumor lesion with a size of ≥ 1 cm assessed by sonography or magnetic resonance imaging (MRI) within ≤ 28 days prior to entry. In case of inflammatory disease, the extent of inflammation will be measured.
    6. Indication for chemotherapy.
    7. Multicentric and/or multifocal disease as well as synchronous bilateral breast cancer is eligible as long as one measurable lesion meets all inclusion criteria. The investigator has to determine which lesion will be used for tumor evaluation before initiation of treatment.
    8. Complete staging within 8 weeks prior to entry with no evidence of distant disease, including bilateral mammography, breast ultrasound, chest-X-ray (or chest CT-scan), liver ultrasound (or liver CT-scan or liver MRI) and bone scan.
    9. Subjects must provide a core biopsy from tumor lesion before first chemotherapy and after last neoadjuvant study treatment for biomarker analyses.
    10. Adequate organ function defined by laboratory values.
    11. Female subjects of childbearing potential must have a negative urine pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the study through 7 months after the last dose of trial treatment.
    Um in die Studie aufgenommen zu werden, muss die Patientin alle unten gelistete Kriterien erfüllen:
    1. Unterschriebene Einverständniserklärung vor Beginn studienspezifischer Maßnahmen.
    2. Es werden nur weibliche Patienten eingeschlossen, das Mindestalter am Tag der Unterschrift der Einverständnis-erklärung beträgt mindestens 18 Jahre.
    3. ECOG 0-1.
    4. Frühes HER2-positives Mammakarzinom, histologisch nachgewiesen mittels Biopsie des Mamma-Tumors.
    5. Messbare Tumorläsion ≥ 1 cm, mittels Mamma-Sonographie oder Magnet-Resonanz-Tomographie (MRT) innerhalb von ≤ 28 Tagen vor Studieneinschluss gemessen. Im Falle eines inflammatorischen Mammakarzinoms wird die Ausprägung der Inflammation beurteilt.
    6. Indikation für eine Chemotherapie.
    7. Sowohl ein multizentrisches und/oder multifokales Karzinom als auch ein gleichzeitig aufgetretenes beidseitiges Mammakarzinom sind zulässig, solange eine messbare Läsion alle Einschlusskriterien erfüllt. Vor Therapiebeginn muss der Prüfarzt die Läsion bestimmen, die zur Tumor-Reevaluation herangezogen werden wird.
    8. Vollständiges Staging (bilaterale Mammographie und -Sonographie, Thorax-Röntgen oder -CT, Leber-Sonographie oder –CT bzw. –MRT, Knochen-Szintigraphie) innerhalb von 8 Wochen vor Studien¬einschluss mit fehlendem Nachweis distaler Metastasen.
    9. Die Patientin ist damit einverstanden, dass zu zwei verschiedenen Zeitpunkten (vor der ersten Applikation der Studienmedikation sowie zur Operation) eine Tumor-Biopsie zur Biomarker-Analyse entnommen wird.
    10. Adäquate Organfunktion festgestellt durch Laborwerte
    11. Frauen im gebärfähigen Alter müssen innerhalb von 72 Stunden vor Studieneinschluss einen negativen Urin-Schwangerschaftstest vorweisen und für die Dauer der Studie bis 7 Monate nach der letzten Gabe der Studienmedikation einer hocheffizienten Verhütung bereit sein
    E.4Principal exclusion criteria
    The subject must be excluded from participating in the trial in following cases:
    1. Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer.
    2. Known hypersensitivity to Ontruzant® or any of the drug excipients.
    3. Prior chemotherapy, radiation therapy or small molecule therapy for any reason.
    4. Previous malignant disease being disease-free for less than 3 years (except in situ carcinoma of the cervix and basal cell carcinoma of the skin).
    5. Pregnancy or breast-feeding.
    6. Prior neoadjuvant therapy.
    7. Active infection requiring systemic therapy.
    8. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
    9. Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs (physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed).
    10. History of primary or acquired immunodeficiency (including allogenic organ transplant).
    11. Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis).
    12. Known history or positive antibody test for any of the following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C, has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
    13. Known congestive heart failure > NYHA I and/or coronary heart disease, angina pectoris, previous history of myocardial infarction, uncontrolled or poorly controlled arterial hypertension (e.g. blood pressure >160/90 mmHg under treatment with two or more antihypertensive drugs), rhythm disorders with clinically significant valvular heart disease.
    14. Pre-existing motor or sensory neuropathy of a severity grade ≥2 by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
    15. Any other condition in opinion of the investigator that would interfere with applied systemic treatment or other trial procedures.
    Patientinnen, auf die eines der folgenden Kriterien zutrifft, sind von der Studien-Teilnahme ausgeschlossen:
    1. Gleichzeitige Teilnahme an einer anderen Medikamentenstudie oder innerhalb von 14 Tagen vor Studieneinschluss oder innerhalb von 5 Halbwertszeiten des untersuchtes Arzneimittels, je nachdem welcher Zeitraum länger ist.
    2. Bekannte Überempfindlichkeit gegen Ontruzant® oder einen der sonstigen Bestandteile des Arzneimittels.
    3. Vorhergehende Chemotherapie, Bestrahlung oder Behandlung mit small molecules aus beliebiger Indikation.
    4. Malignom in der Anamnese, welches weniger als 3 Jahre zurückliegt (abgesehen vom Basalzellkarzinom und Carcinoma in situ der Cervix uteri).
    5. Schwangere oder stillende Frauen.
    6. Vorhergehende neoadjuvante Krebstherapie
    7. Aktive Infektion, die eine systemische Therapie erfordert.
    8. Bestehende oder durchgemachte (nicht-infektiöse) Pneumonitis, welche eine Steroid-Therapie erforderte.
    9. Aktive Autoimmunerkrankung oder andere Erkrankung, welche eine systemische Therapie mit Corticosteroiden oder Immunsuppressiva erfordert (eine physiologische Corticosteroid-Ersatztherapie bei Nebennierenrinden- oder Hypophysen-Insuffizienz ist erlaubt).
    10. Angeborene oder erworbene Immunschwäche (darunter auch die allogene Organ-Transplantation).
    11. Aktive oder durchgemachte chronisch-entzündliche Darmerkrankungen (z.B. Morbus Crohn, Colitis ulcerosa).
    12. Folgende Infektionen in der Anamnese oder ein positiver Antikörpertest auf: Humanes Immundefizienz-Virus (HIV), Akute oder chronische Hepatitis B oder C in der Anamnese, Impfung mit einem Lebendimpfstoff innerhalb von 30 Tagen vor Beginn der Studienmedikation. Grippe-Virus-Impfungen, welche keine Lebendimpfstoffe enthalten, sind erlaubt.
    13. Kongestive Herzinsuffizienz (> Grad I gemäß New York Heart Association [NYHA]) und/oder koronare Herzkrankheit, Angina Pectoris, Myokardinfarkt in der Anamnese, nicht-eingestellte oder schlecht eingestellte arterielle Hypertonie (z.B. Blutdruck >160/90 mmHg unter Therapie mit zwei oder mehr antihypertensiven Medikamenten), Herzrhythmus¬störungen mit klinisch signifikanter Herzklappenerkrankung.
    14. Vorbestehende motorische oder sensorische Neuropathie ≥ Grad 2 nach National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    15. Jeglicher weitere, in den Augen des Prüfarztes für die Studienmedikation oder Studienuntersuchungen als kontraindiziert geltender Zustand.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint will be pCR.
    Primärer endpunkt ist pathologische Komplettremmission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    pCR will be assessed at the time of surgery after completion of study treatement.
    pCR wird zum Zeitpunkt der OP nach Abschluss der Studienbehandlung bestimmt.
    E.5.2Secondary end point(s)
    pCR will be evaluated according to other definitions (pT0/is; ypN0).
    Clinical response will be assessed by imaging.
    The occurrence of AEs, SAEs, fatal SAEs, dose-limiting toxicities, treatment discontinuations and changes in vital signs and laboratory measures will be assessed.
    Health related quality of life will be assessed as changes from baseline, assessed by EORTC-QLQ-C30 and EORTC-QLQ-BR23.
    pCR wird nach weiteren Definitionen (z.B. pT0/is; ypN0 ausgewertet.
    Klinisches Ansprechen wird mittels Bildgebung verfolgt.
    Die Häufigkeit von AEs, SAEs, dosislimitierenden AEs, Behandlungsabbrüchen und Änderungen der Vitalparameter bzw. Laborwerte werden erfasst.
    Lebensqualität wird mittels Fragebögen (EORTC-QLQ-C30 und EORTC-QLQ-BR23) erfasst und der Fragebogenscore gegenüber Baseline verglichen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    pCR will be assessed at the time of surgery after completion of study treatement.
    Clinical response will be assessed every 3-4 treatment cycles, depending on choice of chemotherapy.
    Patient safety will be assessed continuously during the trial.
    Quality of life will be assessed every 3-4 treatment cycles, depending on choice of chemotherapy.
    pCR wird zum Zeitpunkt der OP nach Abschluss der Studienbehandlung bestimmt.
    Klinisches Ansprechen wird alle 3-4 Behandlungszyklen untersucht, in Abhängigkeit des gewählten Chemotherapieregimes.
    Die Patientensicherheit wird kontinuierlich über den gesamten Studienverlauf untersucht.
    Lebensqualität wird alle 3-4 Behandlungszyklen untersucht, in Abhängigkeit des gewählten Chemotherapieregimes.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers will be correlated with efficacy of the IMP.
    Der Einfluss bestimmter Biomarker auf die Wirksamkeit von Ontruzant wird untersucht.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned12
    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
    Last visit of the last subject. (LVLS)
    Letzte Studienvisite der letzten Patientin.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months20
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 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 state98
    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.
    Keine.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation AGO-B Breast Study Group
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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