Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-000674-28
    Sponsor's Protocol Code Number:DMP-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000674-28
    A.3Full title of the trial
    A phase II trial evaluating the activity of cabozantinib in pre-treated patients with metastatic colorectal cancer (mCRC).
    Studio di fase II per valutare l'attività di cabozantinib in pazienti pretrattati affetti da tumore del colon-retto metastatico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial with cabozantinib in patients with metastatic colorectal cancer, after previous treatment (mCRC).
    Studio di fase II con cabozantinib in pazienti affetti da tumore del colonretto metastatico pre-trattato.
    A.3.2Name or abbreviated title of the trial where available
    ABACO trial
    Studio ABACO
    A.4.1Sponsor's protocol code numberDMP-001
    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 SponsorDipartimento di Medicina di Precisione - Università degli studi della Campania "L. Vanvitelli"
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Medicina di Precisione - Università degli studi della Campania "L. Vanvitelli"
    B.5.2Functional name of contact pointDipartimento di Medicina di Precisi
    B.5.3 Address:
    B.5.3.1Street Addressvia pansini, 5
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0815666688
    B.5.6E-maildaniela.renato.trials@outlook.it
    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 - 60 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCABOZANTINIB
    D.3.2Product code [NA]
    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.3.9.1CAS number 849217-68-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCABOZANTINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Patients with mCRC progressed after =2 lines of standard treatment
    Pazienti affetti da tumore del colon-retto metastatico in progressione dopo =2 linee di trattamento
    E.1.1.1Medical condition in easily understood language
    pretreated metastatic colorectal cancer
    tumore del colon-retto metastatico, pretrattato
    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 10053548
    E.1.2Term Gastrointestinal cancer metastatic
    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
    To determine the anti-tumour activity of cabozantinib (evaluated as the number of patients that are free of progression at 16 weeks since the start of treatment) in chemorefractory patients with mCRC, after progression from =2 lines of treatment.
    Tasso di sopravvivenza libera da progressione (PFS) a 16 settimane: il tasso di pazienti liberi da progressione di malattia o morte per qualsiasi causa a 16 settimane.
    E.2.2Secondary objectives of the trial
    To explore the efficacy and the safety of cabozantinib in chemorefractory patients with mCRC, after progression from =2 lines of treatment.
    Esplorare l'efficacia e il profilo di tossicità di cabozantinib in pazienti pretrattati affetti da mCRC dopo progressione =2 linee di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically proven diagnosis of colorectal adenocarcinoma.
    2. Male or female patients = 18 years of age.
    3. Diagnosis of metastatic disease.
    4. Known RAS status (NRAS and KRAS exon 2,3 and 4) per local
    laboratory assessment.
    5. Patients should have received at least two standard lines of treatment including all the following: fluoropyrimidines, irinotecan, oxaliplatin, anti-angiogenic drugs (eg. bevacizumab and or aflibercept) and, in case of patients harbouring RAS WT tumours, anti-Epidermal Growth Factor receptors monoclonal antibodies (cetuximab or panitumumab). Note:
    Prior treatment with trifluridine-tipiracil is allowed.
    6. Recovery to baseline or = Grade 1 CTCAE v.5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
    7. Measurable disease according to RECIST criteria v1.1.
    8. ECOG Performance Status 0-1.
    9. Life expectancy of at least 3 months.
    1. Diagnosi istologica di adenocarcinoma del colon-retto.
    2. Pazienti di sesso maschile o femminile di età = 18 anni.
    3. Diagnosi di malattia metastatica.
    4. Stato RAS noto (NRAS e KRAS esoni 2,3 e 4) per valutazione locale.
    5. I pazienti devono aver ricevuto almeno due linee di trattamento standard, inclusi tutti i seguenti: fluoropirimidine, irinotecan, oxaliplatino, farmaci anti-angiogenici (ad esempio bevacizumab e/o aflibercept) e, in caso di pazienti con tumore RAS WT, anticorpi monoclonali anti-EGFR (cetuximab o panitumumab). Nota: è consentito un trattamento precedente con trifluridina-tipiracile.
    6. Recupero da tossicità correlate a precedenti trattamenti (= Grado 1 secondo CTCAE v.5.0) a meno che tali eventi non siano clinicamente non significativi e / o stabili con appropriata terapia di supporto.
    7. Malattia misurabile secondo i criteri RECIST v1.1.
    8. Stato prestazioni ECOG 0-1.
    9. Aspettativa di vita di almeno 3 mesi.
    E.4Principal exclusion criteria
    1. Prior treatment with cabozantinib.
    2. Prior treatment with VEGFR-targeting TKI (e.g. regorafenib).
    3. Treatment with any anticancer drug within 4 weeks before study entry.
    4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before study entry. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
    5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before study entry. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of study entry.
    1. Trattamento precedente con cabozantinib.
    2. Trattamento precedente con tirosin-chinasico contro il VEGFR (ad esempio regorafenib).
    3. Trattamento con qualsiasi farmaco antitumorale entro 4 settimane prima dell'ingresso nello studio.
    4. Radioterapia per metastasi ossee entro 2 settimane, qualsiasi altra radioterapia esterna entro 4 settimane prima dell'ingresso nello studio.
    Nota: Non sono eleggibili i pazienti con note complicanze, in corso e clinicamente rilevanti, derivanti da precedenti radioterapie.
    5. Metastasi cerebrali note o malattia epidurale craniale se non adeguatamente trattate con radioterapia e / o chirurgia (inclusa radiochirurgia) e stabili per almeno 3 mesi prima dell'ingresso nello studio. I soggetti eleggibili devono essere neurologicamente asintomatici e senza trattamento con corticosteroidi al momento dell'ingresso nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) rate at 16 weeks: the rate of patients who have not experienced disease progression or death for any cause at 16 weeks.
    Tasso di sopravvivenza libera da progressione (PFS) a 16 settimane: il tasso di pazienti liberi da progressione di malattia o morte per qualsiasi causa a 16 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumour assessments every 8 weeks
    Valutazioni radiologiche ogni 8 settimane
    E.5.2Secondary end point(s)
    Progression Free survival (PFS): calculated from the start of the study treatment until disease progression or death for any cause.
    Overall Survival (OS): calculated from the start of the study treatment until death for any cause.
    Response Rate (RR): assessed according to RECIST criteria 1.1, as the rate of patients with complete response or partial response, as best response.
    Disease Control Rate (DCR): assessed according to RECIST criteria 1.1, as the rate of patients with complete response, partial response and stable disease, as best response.
    Safety: Adverse events graded according Events (CTCAE) Version 5.0
    Sopravvivenza libera da progressione (PFS): calcolata dall'inizio del trattamento dello studio fino alla progressione di malattia o alla morte per qualsiasi causa.
    Sopravvivenza globale (OS): calcolata dall'inizio del trattamento dello studio fino alla morte per qualsiasi causa.
    Tasso di risposta (RR): valutato secondo i criteri RECIST 1.1 come il tasso di pazienti che hanno ottenuto come migliore risposta una risposta completa o risposta parziale.
    Tasso di controllo delle malattia (DCR): valutato secondo i criteri RECIST 1.1, come il tasso di pazienti che hanno ottenuto come migliore risposta una risposta completa, una risposta parziale e stabilità di malattia
    Profilo di tollerabilità: eventi avversi classificati secondo I Criteri per Eventi Avversi (CTCAE) Versione (v.) 5.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumour assessments every 8 weeks.
    Safety will be assessed every 2 weeks up to Week 9 Day 1, and every 4 weeks thereafter.
    Valutazioni radiologiche ogni 8 settimane
    Il profilo di tollerabilità verrà valutato ogni 2 settimane fino alla settimana 9, giorno 1, a seguire ogni 4 settimane
    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 Yes
    E.8.1.7.1Other trial design description
    In Aperto
    Open
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    The Whole trial may be discontinued prematurely in the event of any of the following:
    New information leading to unfavorable risk-benefit judgment of the
    trial drug
    Unfavorable safety findings
    Sponsor's decision that continuation of the trial is unjustifiable for
    medical or ethical reasons
    Poor enrollment of subjects
    L'intero trial può essere prematuramete discontinuato se: si rendono disponibili nuovi dati su un rapporto rischio/beneficio non favorevole per il trattamento altre informazioni di sicurezza non favorevoli
    decisione dello Sponsor basata su motivi clinici/etici
    scarso arruolamento
    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 months36
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days10
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 33
    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
    nessuno
    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 Decision2019-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 18 15:36:47 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA