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    Summary
    EudraCT Number:2018-000682-36
    Sponsor's Protocol Code Number:NL65109.091.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-05-16
    Trial results View 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 number2018-000682-36
    A.3Full title of the trial
    The efficacy of cabozantinib in advanced salivary gland cancer patients, a phase II clinical trial
    de effectiviteit van cabozantinib in gevorderd speekselkliercarcinoom, een fase 2 studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    cabozantinib for salivary gland cancer patients
    cabozantinib voor speekselklierkanker
    A.3.2Name or abbreviated title of the trial where available
    Cabo ASAP
    Cabo ASAP
    A.4.1Sponsor's protocol code numberNL65109.091.18
    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 SponsorRadboud university medical center
    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 supportIpsen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud university medical center
    B.5.2Functional name of contact pointHettie Maters
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailhettie.maters@radboudumc.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 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 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
    Salivary gland cancer
    Speekselklierkanker
    E.1.1.1Medical condition in easily understood language
    salivary gland cancer
    Speekselklierkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.
    het bepalen van de overall response rate (ORR) van cabozantinib bij gevorderd speekselkliercarcinoom. ORR is gedefinieerd als de som van het aantal complete remissies en partiele responsen. de beste respons zal bij iedere patiënt worden gebruikt.
    E.2.2Secondary objectives of the trial
    - Assess the progression free survival (PFS). PFS will be defined as time from study enrollment until disease progression or death.
    - Assess the overall survival (OS). OS will be defined as time from study enrollment until date of death of any cause.
    - Asses the duration of response (DoR). DoR is defined as time from study enrollment until date of documented tumor progression or death
    - Assess the toxicity of cabozantinib. Toxicity will be scored according to NCI CTC common criteria v 4.0.10
    - Assess the quality of life (QoL) of patients treated with cabozantinib using EORTC questionnaires.
    - Assess the response rate by using continuous tumor shrinkage end-points.
    - circulating tumor DNA will be assessed to evaluate whether response and disease progression can be predicted.
    - bepalen van de progressie vrije overleving.
    - bepalen van de totale overleving.
    - bepalen van de responsduur.
    - bepalen van de toxiciteit van cabozantinib
    - bepalen van de kwaliteit van leven van patiënten die worden behandeld met cabozantinib
    - bepalen van de response rate door het gebruik van continue tumor krimp eindpunten/
    - circulerend tumor DNA zal worden bepaald om te bekijken of respons en ziekteprogressie kan worden voorspeld.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a patient must meet all of the following criteria:
    - Disease specific
    - locally advanced, recurrent, and/or metastatic SGC (excluding sarcomas and mesenchymal tumors)
    - c-MET positive disease (see paragraph 4.1)
    - Measurable disease per RECIST version 1.1
    - Cohort-specific criteria
     - SDC cohort: Direct inclusion (no objective tumor growth prior to inclusion needed)
     - ACC cohort: Inclusion after objective growth in the last three months or complaints due to the disease
     - Other SGC’s: Inclusion after objective growth in the last three months or complaints due to the disease
    - General conditions
    - Age ≥18 years
    - Eastern Cooperative Oncology Group performance status of 0 or 1.
    - Normal number of neutrophils and thrombocytes
    - Liver function: ALT and AST < 2.5 x upper limit of normal (ULN), Total bilirubin ≤ 1.5 x ULN (except for Gilbert’s syndrome),
    serum albumine ≥28 g/L
    - Renal function: Creatinine < 1.5 x ULN or calculated creatinine clearance ≥ 40 ml/min,
    Urine protein/creatinine ratio ≤113.1 mg/mmol (≤1 mg/mg) or 24-hour urine protein <1 g
    - Hemoglobin A1c (HbA1c) ≤ 8% or a fasting serum glucose ≤ 9 mmol/l
    om deel te nemen moet een patiënt al de volgende criteria voldoen:
    - ziekte specifiek
    - lokaal gevorderd, lokaal recidiverend en of gemetastaseerd speekselkliercarcinoom (geen sarcomen en mesenchymale tumoren)
    - c-MET positieve ziekte
    - meetbare ziekte volgens RECIST version 1.1
    - Cohort-specifieke criteria
     - SDC cohort: directe inclusie (geen objectieve tumorgroei nodig)
     - ACC cohort: Inclusie na objectieve tumorgroei of klachten door de ziekte
     - andere SGC’s: Inclusie na objectieve tumorgroei of klachten door de ziekte
    - algemene voorwaarden
    - leeftijd ≥18 jaar
    - Eastern Cooperative Oncology Group performance status van 0 of 1.
    - Normaal aantal neutrofielen en thrombocyten
    - Lever functie: ALT en AST < 2.5 x upper limit of normal (ULN), Totaal bilirubine ≤ 1.5 x ULN (behalve voor Gilbert’s syndroom),
    serum albumine ≥28 g/L
    - nierfunctie: Creatinine < 1.5 x ULN or berekende klaring ≥ 40 ml/min,
    Urine eiwit/creatinine ratio ≤113.1 mg/mmol (≤1 mg/mg) of 24-hour urine eiwit <1 g
    - Hemoglobin A1c (HbA1c) ≤ 8% of een nuchter serum glucose ≤ 9 mmol/l
    E.4Principal exclusion criteria
    - General conditions
    - A known allergy for cabozantinib or its components
    - Long QT-syndrome
    - Pregnancy or lactation
    - Patients (M/F) with reproductive potential not implementing adequate contraceptives measures
    - Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least
    3 months before inclusion
    - Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before
    inclusion and from minor surgery at least 10 days before inclusion
    - Uncontrolled illness including, but not limited to
     - Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
     - Uncontrolled hypertension defined as sustained systolic BP > 150 mm Hg, or diastolic BP > 100 mm Hg
     - Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion
     - Serious active infections
    - Concomitant treatments
    - Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation.
    - Concurrent treatment with any other anti-cancer therapy.
    - Concomitant anticoagulation.
     - Low dose aspirin for cardioprotection and low dose LMWH are permitted.
    - Radiation therapy within the last 4 weeks before inclusion
    - algemene omstandigheden
    - allergie voor cabozantinib
    - Lang QT-syndroom
    - zwangerschap of borstvoeding
    - Patienten (M/V) in reproductieve levensfase die geen adequate contraceptive maatregelen nemen
    - bekende hersenmetastasen of craniale epidurale ziekte tenzij adequaa behandeld met radiotherapie en/of chirurgie of stabiel voor
    ten minste 3 maanden voor inclusie
    - grote chirurgie binnen 3 maanden voor inclusie. complete wondgenezing moet voor 1 maand bestaan. voor kleine chirurgie geldt
    een termijn van 10 dagen.
    - ongecontrollerde ziekte, inclusief, maar niet gelimiteerd tot:
     - hartfalen, ritmestoornissen
     - ongecontroleerde hypertensie
     - beroerte of TIA, of ander ischemisch event 6 maanden voor inclusie
     - Serieuze actieve infecties
    - Concomitante behandelingen
    - een andere experimentele behandeling
    - een andere anti kanker behandeling
    - Concomitante antistolling. lage dosis aspirine en lage dosis LMWH's zijn toegestaan.
    - Radiotherapie binnen 4 weken voor inclusie
    E.5 End points
    E.5.1Primary end point(s)
    Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.
    het bepalen van de overall response rate (ORR) van cabozantinib bij gevorderd speekselkliercarcinoom. ORR is gedefinieerd als de som van het aantal complete remissies en partiele responsen. de beste respons zal bij iedere patiënt worden gebruikt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    in the first year of treatment, a evaluation CT will be made every 8 weeks, in the second year of treatment, an evaluation CT will be made every 12 weeks.
    in het eerste jaar van behandeling wordt iedere 8 weken een CT gemaakt, in het 2e jaar iedere 12 weken.
    E.5.2Secondary end point(s)
    - Assess the progression free survival (PFS). PFS will be defined as time from study enrollment until disease progression or death.
    - Assess the overall survival (OS). OS will be defined as time from study enrollment until date of death of any cause.
    - Asses the duration of response (DoR). DoR is defined as time from study enrollment until date of documented tumor progression or death
    - Assess the toxicity of cabozantinib. Toxicity will be scored according to NCI CTC common criteria v 4.0.10
    - Assess the quality of life (QoL) of patients treated with cabozantinib using EORTC questionnaires.
    - Assess the response rate by using continuous tumor shrinkage end-points.
    - circulating tumor DNA will be assessed to evaluate whether response and disease progression can be predicted.
    - bepalen van de progressie vrije overleving.
    - bepalen van de totale overleving.
    - bepalen van de responsduur.
    - bepalen van de toxiciteit van cabozantinib
    - bepalen van de kwaliteit van leven van patiënten die worden behandeld met cabozantinib
    - bepalen van de response rate door het gebruik van continue tumor krimp eindpunten/
    - circulerend tumor DNA zal worden bepaald om te bekijken of respons en ziekteprogressie kan worden voorspeld.
    E.5.2.1Timepoint(s) of evaluation of this end point
    progression free surival and duration of response will be evaluated using CT-scans (as the primary outcome).
    overall survival and toxicity will be evaluated at every visit.
    quality of life quesionairres will be taken 7 times, blood for circulating tumor DNA first every 2 week, en thereafter at every CT.
    progressievrije overleving en responsduur worden middels CT geevalueerd (zie primaire uitkomst)
    overall survival en toxiciteit worden bij ieder bezoek geevalueerd.
    kwaliteit van leven vragenlijsten worden 7x afgenomen, bloed voor circulerend tumor DNA eerst iedere 2 weken, en daarna bij iedere CT
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 last subject
    laatste bezoek van laatste patient
    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 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state43
    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)
    resume normale treatment
    hervatten van reguliere behandelingen
    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 Decision2018-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-05
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