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    Summary
    EudraCT Number:2019-004126-13
    Sponsor's Protocol Code Number:CaPture
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-004126-13
    A.3Full title of the trial
    Cabozantinib treatment in a phase II study for patients with hepatocellular carcinoma (HCC) refractory to PD-1 or PD-L1 inhibitors
    Cabozantinib-Behandlung in einer Phase-II-Studie für Patienten mit hepatozellulärem Karzinom (HCC), bei denen eine Behandlung mit einem PD-1- oder PD-L1-Inhibitor nicht erfolgreich war
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cabozantinib treatment for patients with hepatocellular carcinoma (HCC) refractory to previous treatment
    Cabozantinib-Behandlung für Patienten mit Leberzellkarzinom, bei denen eine vorhergehende Behandlung nicht erfolgreich war
    A.3.2Name or abbreviated title of the trial where available
    CaPture
    A.4.1Sponsor's protocol code numberCaPture
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04767906
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Leipzig
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Leipzig
    B.5.2Functional name of contact pointFlorian van Bömmel
    B.5.3 Address:
    B.5.3.1Street AddressLiebigstraße 20
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number00493419712330
    B.5.5Fax number00493419712339
    B.5.6E-mailflorian.vanBoemmel@medizin.uni-leipzig.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    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 nameCabometyx
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    D.2.1.2Country which granted the Marketing 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 nameCabometyx
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    D.2.1.2Country which granted the Marketing 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 nameCabometyx
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    Hepatocellular carcinoma
    Hepatozelluläres Karzinom
    E.1.1.1Medical condition in easily understood language
    Hepatocellular carcinoma
    Leberzellkrebs
    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 assess feasibility, safety and efficacy signals of Cabozantinib in patients with prior non-response or disease progression during a PD-1 or PD-L1 inhibitor treatment.
    Beurteilung der Durchführbarkeit, Sicherheit und Wirksamkeit der Behandlung mit Cabozantinib für Patienten, bei denen eine Behandlung mit einem PD-1 oder PD-L1-Inhibitor nicht erfolgreich war.
    E.2.2Secondary objectives of the trial
    1. Survival and response:
    a) Overall survival (OS)
    b) Progression-free survival (PFS)
    c) Duration of response (DoR)
    d) Response rates including ORR
    2. Feasibility
    e) Median average dose
    3. Image-based endpoints
    f) Tumor progression
    g) Progression of tumoral macrovascular invasion
    h) Progression of extrahepatic HCC manifestations
    i) Total tumor volume
    j) Affection rate
    4. Biomarkers and health status
    k) Concentration of Alpha-fetoprotein
    l) Child-Pugh classification score
    m) ECOG Performance status
    5. Safety
    1. Überleben und Ansprechen:
    a) Gesamtüberlebensdauer (OS)
    b) Progressionsfreies Überleben (PFS)
    c) Dauer des Ansprechens (DoR)
    d) Ansprechraten einschließlich Gesamtansprechrate (ORR)
    2. Durchführbarkeit
    e) Median der mittleren wöchentlichen Dosis
    3. Endpunkte aus der Bildgebung
    f) Tumor-Progression
    g) Progression der tumorinduzierten makrovaskulären Invasion
    h) Progression von extrahepatischen HCC-Manifestationen
    i) Tumor-Gesamtvolumen
    j) Befallsrate
    4. Biomarker und Gesundheitsstatus
    k) Konzentration von Alpha-Fetoprotein
    l) Child-Pugh Klassifikationsscore
    m) ECOG Status
    5. Sicherheit
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The aim of the project is to examinate the association of HCC related biomarkers with response to Cabozantinib in patients treated in the study. For this, we will analyse liver biopsy samples as well as circulating markers in patients who are willing to participate in the project.

    Primary endpoint: Association of circulating tumor DNA (ctDNA) with treatment response
    Secondary endpoints:
    1) association of urin tumor DNA (ctDNA) with treatment response
    2) association of the detection of circulating HCC bio markers listed in with treatment response
    3) Association of lymphocyte (PBMC) PD-1 status with treatment response
    4) association of histological and genomic tumour profile at the time point of Cabozantinib initiation with response:
    - DNA-NGS Panel: analysis of 592 Gene (Single number variations, copy number variations) and 2 Gen-Signatures (MSI and TMB)
    - RNA-WTS: whole transriptome for RNA diagnostic for gene fusion and transcript variants
    - Protein-based tests: e.g. MLH1, MSH2, MSH6, PMS and PD-L1
    - CMEt-Status, AXL, VEGF-R2
    5) association of circulation HCC bio markers (AFP, AFP-L3, DCP, GP-3, DKK1) with response to carbozantinib
    E.3Principal inclusion criteria
    1. Patients with diagnosis of locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)
    2. Pre-Treatment with a PD-1/PD-L1 inhibitor for at least one administration which was given as first line or as following line systemic treatment alone or in combination with other systemic or local treatments (e.g. TACE)
    3. Disease progression or end of therapy due to toxicity during/after pre-therapy
    4. CTCAE ≤ Grade 2 prior to study registration, with the exception of alopecia
    5. ECOG (Eastern Cooperative of Onco-logy Group) Index 0 or 1
    6. Age ≥ 18 years
    7. Written informed consent
    1. Patienten mit einem lokal fortgeschrittenen oder metastasierten und/oder inoperablen Leberzellkarzinom (HCC)
    2. Vorbehandlung als Erstlinien- oder Folgelinien-Therapie mit einem PD-1/PD-L1-Inhibitor mit mindestens einer Gabe, die allein und systemisch oder in Kombination mit anderen systemischen oder lokalen Behandlungen (z.B. TACE) verabreicht wurde
    3. Fortschreiten der Krankheit oder Abbruch der Therapie aufgrund von Toxizität während/nach der Vortherapie
    4. CTCAE ≤ Grad 2 vor Studien-Registrierung, mit Ausnahme von Alopezie
    5. ECOG Index 0 oder 1
    6. Patient ist mind. 18 Jahre alt
    7. Schriftliche Einwilligungserklärung des Patienten liegt vor
    E.4Principal exclusion criteria
    1. Significant portal hypertension (moderate or severe ascites)
    2. No adequate controlled arterial hypertension (RR > 140/80mmHg)
    3. ALAT/ASAT five times higher then upper normal value
    4. Hepatic encephalopathy (every stage)
    5. Liver cirrhosis Child-Pugh B or C
    6. Known fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma mixed with HCC
    7. Major surgical procedure, other than for diagnosis, within eight weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
    8. Severe infection with alteration of general condition within four weeks prior to initiation of study treatment
    9. Severely impaired kidney function (CKD: stadium 4: GFR<30)
    10. Myocardial infarction within 12 months prior to initiation of study treatment
    11. Epilepsy
    12. Heart failure, Cardiac arrhythmia, respectively long-QT syndrome
    13. Severe bleeding or high risk for the development of severe bleeding, including esophageal varices > 1° or esophageal varices with red marks as seen on a lighted stomach scope (endoscopy)
    14. Chronic inflammatory bowel disease (e.g. colitis ulcerosa, diverticulitis, Crohn’s disease)
    15. Increased risk of thromboembolism due to medical history or disease
    16. Significant alcohol consumption (>1 drink/day; 1 drink=0.25l beer or 0,1l wine or 2cl spirituous beverages)
    17. Known active HIV infection
    18. Known hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption
    19. Prior Cabozantinib use
    20. Concomitant anticoagulation, at therapeutic doses*
    21. Predicted life expectancy of less than 6 months
    22. Female patients who do not meet at least one of the following criteria:
    • Postmenopausal women (Appendix 18.1) (for at least 1 year before the screening visit) OR
    • Postoperative status (6 weeks after bilateral ovariectomy with or without hysterectomy) OR
    • If they are of childbearing potential, agree to practice one highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) OR
    • Abstinence OR
    • Vasectomy of the partner
    23. Male patients not using one of the following variants for contraception including a period of 4 months after the completion of the therapy:
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. OR
    • Condition after vasectomy OR
    • Condom
    24. Participation in any other interventional trials within 28 days prior to initiation of study treatment
    25. Suspected lack of compliance to previous treatments; inability to take the medication
    26. Pregnancy or lactation, or intention of becoming pregnant during study treatment
    * Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (≤ 1 mg/day), and low-dose LMWH are permitted.
    1. Signifikante Portalhypertonie (mittlere oder schwere Aszites)
    2. Nicht adäquat kontrollierte arterielle Hypertonie (RR > 140/80mmHg)
    3. ALAT/ASAT fünfmal oder mehr höher als der obere Normalwert
    4. Hepatische Enzephalopathie (jedes Stadium)
    5. Leberzirrhose mit Klassifikation Child-Pugh B oder C
    6. Bekanntes fibrolamellares HCC, sarkomatoides HCC oder Cholangiokarzinom gleichzeitig mit HCC
    7. Erheblicher chirurgischer Eingriff, der nicht im Zusammenhang mit der HCC-Diagnose durchgeführt wurde, innerhalb von acht Wochen vor Beginn der Studientherapie, oder voraussichtliche Notwendigkeit eines größeren chirurgischen Eingriffs während der Studie
    8. Schwere Infektion mit Änderung des Allgemeinzustandes innerhalb der letzten vier Wochen vor Beginn der Studientherapie
    9. Schwer beeinträchtigte Nierenfunktion (CKD: Stadium 4: GFR<30)
    10. Myokardinfarkt innerhalb von 12 Monaten vor Beginn der Studietherapie
    11. Epilepsie
    12.Herzinsuffizienz, Herzrhythmusstörungen bzw. Long-QT-Syndrom
    13. Starke Blutungen oder hohes Risiko für die Entwicklung schwerer Blutungen, einschließlich Ösophagusvarizen > 1° oder Ösophagusvarizen mit endoskopisch bestätigtem hohem Blutungsrisiko
    14. Chronisch entzündliche Darmerkrankungen (z.B. Colitis ulcerosa, Divertikulitis, Morbus Crohn)
    15. Erhöhtes Risiko für Thromboembolien aufgrund der Anamnese oder Erkrankung
    16. Starker Alkoholkonsum (> 1 Getränk/Tag; 1 Getränk = 0,25l Bier oder 0,1 l Wein oder 2 cl Spirituosen)
    17. Bekannte aktive HIV-Infektion
    18. Bekannte hereditäre Galaktoseintoleranz, Laktasemangel oder Glukose-Galaktose-Malabsorption
    19. Vorbehandlung mit Cabozantinib
    20. Antikoagulation, in therapeutischen Dosen*
    21. Lebenserwartung von weniger als 6 Monaten
    22. Patientinnen, die mindestens eines der folgenden Kriterien nicht erfüllen:
    • Postmenopausale Frauen (Anhang 18.1) (für mindestens 1 Jahr vor dem Screeningbesuch) ODER
    • Postoperativer Status (6 Wochen nach bilateraler Ovariektomie mit oder ohne Hysterektomie) ODER
    • Wenn sie im gebärfähigen Alter sind, erklären sie sich bereit, eine hochwirksame Verhütungsmethode und eine zusätzliche wirksame (Barriere-)Methode gleichzeitig zu praktizieren, und zwar vom Zeitpunkt der Unterzeichnung der Einwilligungserklärung bis 4 Monate nach der letzten Gabe der Studientherapie ODER
    • Stimmen Sie zu, echte Abstinenz zu praktizieren, wenn dies mit dem bevorzugten und üblichen Lebensstil der Patientin übereinstimmt. (Periodische Abstinenz [z.B. Kalender-, Ovulations-, Symptothermal-, Postovulationsmethoden], Entzug, nur Spermizide und Amenorrhoe in der Stillzeit sind keine akzeptablen Methoden der Empfängnisverhütung. Kondome für die Frau und den Mann sollten nicht zusammen verwendet werden) ODER
    • Abstinenz ODER
    • Vasektomie des Partners
    23. Patienten, die keine der folgenden Varianten zur Empfängnisverhütung verwenden, einschließlich eines Zeitraums von 4 Monaten nach Abschluss der Studientherapie:
    • Stimmen Sie zu, echte Abstinenz zu praktizieren, wenn dies mit dem bevorzugten und üblichen Lebensstil des Patienten übereinstimmt. (Periodische Abstinenz [z.B. Kalender-, Ovulations-, Symptothermal-, Postovulationsmethoden], Entzug, nur Spermizide und Amenorrhoe in der Stillzeit sind keine akzeptablen Methoden der Empfängnisverhütung) ODER
    • Zustand nach Vasektomie-OP ODER
    • Kondom
    24. Teilnahme an einer anderen interventionellen Studie innerhalb von 28 Tagen vor Beginn der Studientherapie
    25. Zu erwartende mangelnde Compliance (z.B. aus Erfahrungen mit Vorbehandlungen); Unfähigkeit zur Einnahme des Studienmedikaments
    26. Schwangerschaft oder Stillzeit oder Absicht, während der Studienbehandlung schwanger zu werden
    * Niedrig dosiertes Aspirin zur Kardioprotektion (gemäß den lokal geltenden Richtlinien), niedrig dosiertes Warfarin (≤ 1 mg/Tag) und niedrig dosiertes LMWH sind erlaubt.
    E.5 End points
    E.5.1Primary end point(s)
    Time on treatment (TT) for patients with HCC who have shown disease progression during treatment with a PD-1 or PD-L1 inhibitor
    Behandlungsdauer (time on treatment) für Patienten mit HCC, die während der Behandlung mit einem PD-1- oder PD-L1-Hemmer ein Fortschreiten der Krankheit gezeigt haben.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of treatment or end of study, respectively.
    E.5.2Secondary end point(s)
    1. Survival and response:
    a) Overall survival (OS)
    b) Progression-free survival (PFS)
    c) Duration of response (DoR)
    d) Response rates including ORR

    2. Feasibility
    e) Median average dose

    3. Image-based endpoints
    f) Tumor progression
    g) Progression of tumoral macrovascular invasion
    h) Progression of extrahepatic HCC manifestations
    i) Total tumor volume (TTV)
    j) Affection rate

    4. Biomarkers and health status
    k) Concentration of Alpha-fetoprotein
    l) Child-Pugh classification score
    m) ECOG Performance status

    5. Safety (descriptive documentation)
    1. Überleben und Ansprechen:
    a) Gesamtüberlebensdauer (OS)
    b) Progressionsfreies Überleben (PFS)
    c) Dauer des Ansprechens (DoR)
    d) Ansprechraten einschließlich Gesamtansprechrate (ORR)

    2. Durchführbarkeit
    e) Median der mittleren wöchentlichen Dosis

    3. Endpunkte aus der Bildgebung
    f) Tumor-Progression
    g) Progression der tumorinduzierten makrovaskulären Invasion
    h) Progression von extrahepatischen HCC-Manifestationen
    i) Tumor-Gesamtvolumen
    j) Befallsrate

    4. Biomarker und Gesundheitsstatus
    k) Konzentration von Alpha-Fetoprotein
    l) Child-Pugh Klassifikationsscore
    m) ECOG Status

    5. Sicherheit (deskriptive Dokumentation)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints (survival, response, feasibility): at end of treatment, documented tumor progression, death, or end of study, respectively.
    Secondary endpoints (image-based endpoints, biomarkers, health status): at visits at 3, 6, 9 and 12 months after registration, and end-of-treatment-visit (if applicable).
    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 concerned7
    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
    The trial formally starts with the registration of the first patient (FPI = first patient in), and the formal end of the study is the last visit of the last patient included (LPO = last patient out).
    Formal beginnt die Studie mit der Registrierung des ersten Patienten (FPI = first patient in), und das formale Ende der Studie ist der letzte Besuch des letzten eingeschlossenen Patienten (LPO = last patient out).
    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 months
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state40
    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)
    The further treatment after 336 days is carried out if the patient is not dead, has not suffered any progress or severe toxicity. If the patient agrees to continue Cabozantinib treatment Ipsen Pharma will provide further medication for individual patient´s treatment.
    Die weitere Behandlung nach 336 Tagen wird durchgeführt, wenn der Patient nicht tot ist, keinen Fortschritt oder eine schwere Toxizität erlitten hat. Ist der Patient mit der Fortsetzung der Cabozantinib-Behandlung einverstanden, stellt Ipsen Pharma weitere Medikamente für die individuelle Behandlung des Patienten zur Verfügung.
    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 Decision2020-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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