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    Summary
    EudraCT Number:2021-002632-23
    Sponsor's Protocol Code Number:IFO21_02
    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:2021-09-07
    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 number2021-002632-23
    A.3Full title of the trial
    A proof-of-concept, biomarker-driven, phase-II clinical trial to explore the activity of decitabine repurposing against advanced, refractory, KRAS-dependent pancreatic ductal adenocarcinoma (PDAC):
    The ORIENTATE (tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr) trial.
    NUOVA INDICAZIONE TERAPEUTICA (RIPOSIZIONAMENTO) DELLA DECITABINA PER IL TRATTAMENTO DI ADENOCARCINOMI DUTTALI PANCREATICI AVANZATI, RESISTENTI A TERAPIE E CON DIPENDENZA DALL’ONCOGENE KRAS: IL TRIAL ORIENTATE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NEW THERAPEUTIC INDICATION OF DECITABINE FOR THE TREATMENT OF ADVANCED, THERAPY-RESISTANT PANCREAS TUMORS WITH A SPECIFIC MOLECULAR PROFILE
    NUOVA INDICAZIONE TERAPEUTICA DELLA DECITABINA PER IL TRATTAMENTO DI TUMORI DEL PANCREAS AVANZATI, RESISTENTI A TERAPIE E CON UNO SPECIFCIO PROFILO MOLECOLARE: IL TRIAL ORIENTATE
    A.3.2Name or abbreviated title of the trial where available
    ORIENTATE
    ORIENTATE
    A.4.1Sponsor's protocol code numberIFO21_02
    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 SponsorISTITUTI FISIOTERAPICI OSPITALIERI
    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 supportANTICANCER FUND
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJANSSEN
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTI FISIOTERAPICI OSPITALIERI
    B.5.2Functional name of contact pointCLINICAL TRIAL CENTER
    B.5.3 Address:
    B.5.3.1Street AddressVIA ELIO CHIANESI 53
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.6E-mailorientate@ifo.gov.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 No
    D.2.1.1.1Trade name DACOGEN - 50 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 20 ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEMEA/H/C/002221/P46/008
    D.3 Description of the IMP
    D.3.1Product nameDECITABINA
    D.3.2Product code [JNS-30979754]
    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 INNDECITABINA
    D.3.9.1CAS number 2353-33-5
    D.3.9.2Current sponsor codeDECITABINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Advanced (locally advanced or metastatic), pre-treated PDAC patients, progressing after at least one and no more than two lines of systemic therapy, whose tumors express a KRAS-dependency signature.
    Pazienti con adenocarcinoma duttale pancreatico avanzato (localmente
    avanzati o metastatici), pretrattati, in progressione dopo almeno una e
    non più di due linee di terapia sistemica, i cui tumori esprimono una
    firma molecolare di dipendenza da KRAS valutata attraverso analisi di
    espressione genica
    E.1.1.1Medical condition in easily understood language
    Advanced (locally advanced or metastatic), pre-treated PDAC patients, progressing after at least one and no more than two lines of systemic therapy, whose tumors express a specific signature.
    Pazienti con tumore del pancreas localmente
    avanzato o metastatico, pretrattato, in progressione dopo almeno una e
    non più di due linee di terapia sistemica, con uno specifico profilo molecolare
    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 LLT
    E.1.2Classification code 10051971
    E.1.2Term Pancreatic adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to provide proof-of-concept of DEC antitumor activity in dKRAS metastatic PDAC.
    L'obiettivo principale dello studio è fornire una validazione clinica
    preliminare dell'attività antitumorale (studio di fase II) della DEC nei
    pazienti con PDAC metastatico e con profilo molecolare di dKRAS.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial are to assess the feasibility of a molecularly tailored approach in advanced, pre-treated PDAC, as well as to assess treatment safety and tolerability, clinical benefit, impact on quality of life, and survival outcomes.
    Gli obiettivi secondari dello studio sono la valutazione della fattibilità
    di un approccio di terapia personalizzata su base molecolare, in
    pazienti PDAC avanzati e pretrattati, nonché la valutazione della
    sicurezza e della tollerabilità del trattamento, del beneficio clinico,
    dell'impatto sulla qualità della vita e sulla sopravvivenza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Age = 18 years;
    2. Histologically or cytologically proven, advanced, inoperable (metastatic or locally advanced), PDAC;
    3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
    4. Life expectancy of at least 12 weeks;
    5. At least one and no more than two lines of systemic treatment for advanced disease;
    6. At least one metastatic lesion(s) and/or primary tumor amenable to pre-treatment biopsy;
    7. KRAS dependency, as assessed by molecular analysis of RNA isolated from a fresh tumor biopsy;
    8. Imaging-documented progressive disease (PD), according to modified RECIST 1.1 criteria;
    9. Imaging-documented measurable disease, according to modified RECIST 1.1 criteria;
    10. Adequate organ and marrow function;
    11. Postmenopausal status or evidence of non-childbearing status (negative urine or serum pregnancy test) for women of childbearing potential;
    12. Women of childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use two highly effective forms of contraception while they are receiving study treatment and for 3 months after last dose of study drug. Male subjects must agree to refrain from sperm donation during the study and for 30 days after the last dose of study drugs;
    13. Ability to understand and willingness to sign an appropriate written informed consent form (ICF). Signed informed consent form must be obtained prior to initiation of study-related activities.
    1. Età = 18 anni;
    2. Adenocarcinoma Duttale Pancreatico (PDAC) istologicamente o
    citologicamente diagnosticato, avanzato, inoperabile (metastatico o
    localmente avanzato);
    3. Performance Status 0-2 dell'Eastern Cooperative Oncology Group
    (ECOG);
    4. Aspettativa di vita di almeno 12 settimane;
    5. Almeno una e non più di due linee di trattamento sistemico per la malattia
    avanzata;
    6. Almeno una o più lesioni metastatiche e/o tumori primitivi che possano
    essere sottoposte a biopsia pre-trattamento;
    7. Dipendenza da KRAS, valutata mediante analisi molecolare dell' RNA
    isolato da una nuova biopsia tumorale;
    8. Evidenza di progressione di malattia (PD) documentata da diagnostica per
    immagini, secondo i criteri RECIST 1.1 modificati;
    9. Malattia misurabile documentata da immagini, secondo i criteri RECIST
    1.1 modificati;
    10. Adeguata funzione degli organi e del midollo;
    11. Stato postmenopausale o evidenza di stato non fertile (test di gravidanza
    su siero o urine negativo) per le donne in età fertile;
    12. Le donne in età fertile (definite come non in post-menopausa per 12 mesi
    o senza precedente sterilizzazione chirurgica) e gli uomini fertili devono
    accettare di utilizzare due forme contraccettive altamente efficaci durante
    il trattamento in studio e per 3 mesi dopo l'ultima dose di studio farmaco.
    I soggetti di sesso maschile devono accettare di astenersi dalla donazione
    di sperma durante lo studio e per 30 giorni dopo l'ultima dose di farmaci
    in studio;
    13. Capacità di comprensione e disponibilità a firmare un appropriato
    modulo di consenso informato (ICF). Il modulo di consenso informato
    debitamente firmato deve essere ottenuto prima dell'inizio delle attività
    correlate allo studio.
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Uncontrolled intercurrent illness(es);
    2. Pregnancy or lactation;
    3. Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;
    4. Major surgical intervention within 4 weeks prior to enrollment;
    5. Radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to signing the treatment ICF;
    6. Any previous treatment with DEC;
    7. Patients with second primary cancers, except for adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) treated with curative intent and with no evidence of active disease at >1 year from the completion of curative treatment prior to study entry;
    8. Persistent toxicities (=CTCAE grade 2) caused by previous cancer therapy, excluding alopecia;
    9. Serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug;
    10. Serious psychiatric or medical conditions that could interfere with a valid informed consent.
    1. Malattie in corso e non sotto controllo medico;
    2. Gravidanza o allattamento;
    3. Infezioni batteriche, virali o fungine attive e incontrollate che richiedono
    terapia sistemica;
    4. Intervento chirurgico nelle 4 settimane precedenti l'arruolamento;
    5. Radioterapia, chirurgia, chemioterapia o terapia sperimentale entro 2
    settimane prima della firma dell’ICF al trattamento;
    6. Eventuali trattamenti precedenti con DEC;
    7. Pazienti con ulteriori tumori primari, ad eccezione di carcinoma cutaneo
    non-melanoma adeguatamente trattato, carcinoma in situ della cervice
    trattato in modo curativo, carcinoma dell'endometrio di stadio 1, di grado
    1 o altri tumori solidi inclusi i linfomi (senza coinvolgimento del midollo
    osseo) trattati a scopo curativo e senza evidenza di malattia attiva a piu di
    1 anno dal completamento del trattamento a scopo di cura prima
    dell'ingresso nello studio;
    8. Tossicità persistente (di grado CTCAE = 2) causate da una precedente
    terapia antitumorale, esclusa l'alopecia;
    9. Gravi fattori di rischio medico che coinvolgono uno qualsiasi dei
    principali organi tali che lo sperimentatore ritenga pericoloso per il
    paziente ricevere un farmaco sperimentale;
    10. Gravi condizioni psichiatriche o mediche che potrebbero interferire con
    un valido consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    Best Overall Response Rate (BOR) according to RECIST1.1.
    Tasso di miglior risposta globale (BOR) secondo RECIST1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    BOR is not a time-dependent endpoint and it is calculated based on the best overall response, whenever it occurs during the trial.
    BOR non è dipendente dal tempo ed è calcolato considerando la migliore risposta, in qualunque momento avvenga.
    E.5.2Secondary end point(s)
    Disease-control rate (DCR); Toxicity rate according to NCI-CTC v5.0; Progression-Free Survival (PFS)/Overall Survival (OS)
    Tasso di controllo della malattia (DCR); Incidenza di tossicità in accordo al NCI-CTC v5.0; Progression-Free Survival (PFS)/Overall Survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    DCR is not a time-dependent endpoint and it is calculated based on the best overall response (BOR), whenever it occurs during the trial.; After each cycle; At the end of study
    DCR non è dipendente dal tempo ed è calcolato considerando la migliore risposta (BOR), in qualunque momento avvenga.; Dopo ogni ciclo; Alla fine dello studio
    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 No
    E.6.5Efficacy No
    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.8.2.4Number 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 concerned6
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days73
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days73
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 17
    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)
    According to standard of care
    Secondo pratica clinica
    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 Decision2021-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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