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    Summary
    EudraCT Number:2020-002541-41
    Sponsor's Protocol Code Number:02679
    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:2020-11-26
    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 number2020-002541-41
    A.3Full title of the trial
    A phase II trial of Cabozantinib in patients with advanced, low proliferative NEN G3.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial of Cabozantinib medication in patients with advanced, high-grade neuroendocrine neoplasms, which are either well-differentiated neuroendocrine tumors or poor-differentiated neuroendocrine carcinoma but with a low proliferation rate. Both neuroendocrine neoplasms are insensitive against the available chemotherapy choice, making the newly investigated medication a new hope for better management of these subtypes.
    A.3.2Name or abbreviated title of the trial where available
    CABONEN
    A.4.1Sponsor's protocol code number02679
    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 SponsorUniversitätsmedizin Göttingen
    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 organisationUniversitätsmedizin Göttingen
    B.5.2Functional name of contact pointCabonen-Projectmanagement
    B.5.3 Address:
    B.5.3.1Street AddressVon-Bar-Straße 2/4
    B.5.3.2Town/ cityGöttingen
    B.5.3.3Post code37075
    B.5.3.4CountryGermany
    B.5.4Telephone number004905513960824
    B.5.5Fax number004905513960846
    B.5.6E-mailcabonen@med.uni-goettingen.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.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.4EV Substance CodeSUB93452
    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
    We will include patients with NET G3 and upto four prior antitumoral treatment lines and NEC Ki67 low after failure of standard treatment with conventional chemotherapy.
    E.1.1.1Medical condition in easily understood language
    Patients with neuroendocrine tumor of high-grade with upto four prior antitumoral treatment lines and neuroendocrine carcinoma with low proliferation rate after failure of standard treatment.
    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
    Evaluate the efficacy of Cabozantinib treatment
    E.2.2Secondary objectives of the trial
    Evaluate short- and long term efficacy of Cabozantinib treatment, evaluate necessary exposure time, assess quality-of-life during and after Cabozantinib treatment, and to assess general safety of Cabozantinib treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically confirmed diagnosis of neuroendocrine neoplasia;
    2. Tumor proliferation rate has to be > Ki67 20% and ≤ Ki67 60% (local assessment);
    3. Male, female, or diverse patients aged ≥ 18 years without upper age limit;
    4. Patients with up to four different antitumoral therapies
    5. At least one measurable tumor lesion in CT or MRI scan;
    6. Newly diagnosed or progressive disease assessed per RECIST criteria 1.1;
    7. Patients must have a performance status of ECOG 0-2;
    8. Patients must have a life expectancy of more than 3 months;
    9. Hb> 9 g/dl;
    10. Platelets >80T/µl;
    11. White blood cells >3T/μL;
    12. Total bilirubin <3mg/dl;
    13. AST and ALT <4xN;
    14. Serum creatinine <2mg/dl, eGFR >40mL/min/1.73m2;
    15. BUN <5xN;
    16. Lipase <3xN;
    17. Albumin ≥2.8 g/dL;
    18. PT/PTT ≤ 1.5 × ULN;
    19. Urine protein:creatinine ration ≤ 1 (Note: if proteinuria < 2g/l and increased proteinuria is ruled out by an urine teststick the protein:creatinine ratio does not need to be determined);
    20. Written informed consent obtained according to international guidelines and local laws;
    21. Ability to understand the nature of the trial and the trial related procedures and to comply with them
    E.4Principal exclusion criteria
    1. Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN);
    2. Patients with former treatment with TKI or VEGF receptor antagonist;
    3. Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer);
    4. Patients with symptomatic brain metastases;
    5. Patients with known HIV infection, acute and chronic-active hepatitis (type A, B or C) or another uncontrolled infection;
    6. Patients with known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC);
    7. Patients with class III or IV congestive heart failure;
    8. Patients with prolonged QTc (for women more than 470 ms, for men 450 ms);
    9. Patients with uncontrolled hypertension (despite anti-hypertensive medication RR >160/110 mmHg);
    10. Patients with severely impaired lung function;
    11. Patients with history of organ transplant (exclusion: cornea transplantation);
    12. Patients with clinical apparent acute or chronic gastric ulceration;
    13. Patients with history of hemophilia;
    14. Patients with surgery at the GI tract within the last 12 weeks;
    15. Patients with patients with uncontrolled inflammatory bowel disease;
    16. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
    17. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
    18. Previous participation in this trial
    19. concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone);
    20. Known or persistent abuse of medication, drugs or alcohol;
    21. Person who is in a relationship of dependence/employment with the sponsor or the investigator;
    22. Current or planned pregnancy, nursing period
    E.5 End points
    E.5.1Primary end point(s)
    Disease control rate (DCR) (Complete Response, CR + Partial Response, PR + Stable Disease, SD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after treatment start
    E.5.2Secondary end point(s)
    Disease control rate (DCR).
    Progression free survival (PFS) and overall survival (OS).
    Time on drug (TOD).
    EORTC QLQ-C30 Quality of Life Questionnaire monthly.
    Serious adverse events and adverse events, Data Safety Monitoring Board (DSMB) after 20 patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 and 12 months after treatment start.
    For the QoL: monthly for 12 months after treatment start and after 15 months
    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.8.2.4Number 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    End of trial defined as last patient last visit (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 0
    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)
    After end of the trial, continuation of trial medication is at the discretion of the treating physician, international standards, German treatment guidelines, and good clinical practice. For patients who will benefit from treatment after end of the trial in terms of efficacy (complete response, partial response, or stable disease) while having no or tolerable toxicity may stay on Cabozantinib. Medication will be provided by the financial sponsor of this trial Ipsen Pharma GmbH.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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