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    Summary
    EudraCT Number:2016-002422-36
    Sponsor's Protocol Code Number:INCB54828-202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002422-36
    A.3Full title of the trial
    A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy
    Studio di fase 2, in aperto, a braccio singolo, multicentrico per valutare l’efficacia e la sicurezza di INCB054828 nei soggetti con colangiocarcinoma in stadio avanzato/metastatico o non resecabile chirurgicamente, incluse le traslocazioni del FGFR2, che non hanno risposto a precedenti terapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With AdvancedCholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy
    Studio di fase 2, in aperto, a braccio singolo, multicentrico per valutare l’efficacia e la sicurezza di INCB054828 nei soggetti con colangiocarcinoma in in stadio avanzato incluse le traslocazioni del FGFR2 che non hanno risposto a precedenti terapie
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB0548
    Studio di fase 2, in aperto, a braccio singolo, multicentrico per valutare l’efficacia e la sicurezz
    A.4.1Sponsor's protocol code numberINCB54828-202
    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 SponsorINCYTE CORPORATION
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte orporation
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number13024252734
    B.5.5Fax number13024252734
    B.5.6E-mailRA@incyte.com
    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.2.5The 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.3.2Product code INCB054828
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeINCB054828
    D.3.9.4EV Substance CodeSUB183791
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 4
    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
    Subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocations, with other FGF/FGFR alterations, or who are negative for any FGF/FGFR alterations, who failed at least 1 previous treatment.
    I soggetti affetti da colangiocarcinoma in stadio avanzato/metastatico o non resecabile chirurgicamente con traslocazioni di FGFR2, con altre alterazioni di FGF/FGFR o che sono negativi a qualsiasi alterazione di FGF/FGFR, che hanno fallito almeno 1 trattamento precedente.
    E.1.1.1Medical condition in easily understood language
    Subjects with advanced cholangiocarcinoma after at least 1 previous treatment.
    I soggetti affetti da colangiocarcinoma in stadio avanzato dopo almeno 1 precedente trattamento
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with fibroblast growth factor receptor (FGFR) 2 translocation who have failed at least 1 previous treatment.
    L’obiettivo primario di questo studio è quello di valutare l’efficacia di INCB054828 in soggetti affetti da colangiocarcinoma in stadio avanzato/metastatico o non resecabile chirurgicamente con traslocazione del recettore del fattore di crescita dei fibroblasti (FGFR) 2, che hanno fallito almeno 1 trattamento precedente.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with different molecular subgroups.
    • To evaluate the safety of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma.
    • To identify and evaluate covariates that may influence the pharmacokinetics of INCB054828 in this subject population through population pharmacokinetic analysis. Additionally, exposure-response analyses for key efficacy and safety parameters will also be considered if sufficient data are available.
    • Valutare l’efficacia di INCB054828 in soggetti affetti da colangiocarcinoma in stadio avanzato/metastatico o non resecabile chirurgicamente con sottogruppi molecolari diversi.
    • Valutare la sicurezza di INCB054828 in soggetti affetti da colangiocarcinoma in stadio avanzato/metastatico o chirurgicamente non resecabile.
    • Identificare e valutare le covariate che possono influenzare la farmacocinetica di INCB054828 in questa popolazione di soggetti attraverso l’analisi farmacocinetica della popolazione. Inoltre, verranno prese in considerazione anche le analisi di risposta all’esposizione per i parametri principali di efficacia e sicurezza se sono disponibili dati sufficienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women, aged 18 or older.
    • Histologically or cytologically confirmed cholangiocarcinoma. Subjects
    will be assigned to 1 of 3 cohorts:
    a. Cohort A: FGFR2 translocations.
    b. Cohort B: other FGF/FGFR alterations.
    c. Cohort C (US only): negative for FGF/FGFR alterations.
    • Radiographically measurable disease per RECIST v1.1.
    • Documentation of FGF/FGFR gene alteration status.
    • Documented disease progression after at least 1 line of prior systemic
    therapy.
    • ECOG performance status of 0 to 2.
    • Life expectancy = 12 weeks.
    Uomini e donne, a partire dai 18 anni di età.
    • Colangiocarcinoma confermato istologicamente o citologicamente. I soggetti saranno assegnati a 1 delle 3 coorti:
    a. Coorte A: traslocazioni di FGFR2.
    b. Coorte B: altre alterazioni di FGF/FGFR.
    c. Coorte C (solo per gli USA): negativi alle alterazioni di FGF/FGFR.
    • Malattia misurabile radiograficamente in base alla versione 1.1 dei Criteri di valutazione della risposta nei tumori solidi (RECIST 1.1)
    • Documentazione dello stato di alterazione del gene di FGF/FGFR.
    • Progressione documentata della malattia dopo almeno 1 linea di terapia sistemica precedente.
    • Stato prestazionale ECOG compreso tra 0 e 2.
    • Aspettativa di vita =12 settimane.
    E.4Principal exclusion criteria
    • Prior receipt of a selective FGFR inhibitor.
    • History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
    • Current evidence of clinically significant corneal or retinal disorder
    confirmed by ophthalmologic examination.
    • Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
    • Ricevimento pregresso di un inibitore selettivo di FGFR.
    • Anamnesi e/o evidenza attuale di mineralizzazione/calcificazione ectopica, incluso, a titolo meramente esemplificativo, tessuto molle, reni, intestino, miocardio o polmoni, ad eccezione di linfonodi calcificati e calcificazioni asintomatiche arteriali o della cartilagine/tendini.
    • Evidenza attuale di disturbo corneale o retinico clinicamente significativo Confermato da un esame oftalmologico.
    • Uso di un qualsiasi potente inibitore o induttore di CYP3A4 entro 14 giorni o 5 emivite, a seconda di quale sia più breve, prima della prima dose di farmaco dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to determine the objective response rate (ORR) in subjects with FGFR2 translocations based on the central genomics laboratory results. Objective response rate is defined as the proportion of subjects who achieved a complete response (CR; disappearance of all target lesions) or a partial response (PR; =30% decrease in the sum of the longest diameters of target lesions) based on RECIST version 1.1. Clinical response will be determined by an independent radiological review committee.
    L’endpoint primario di questo studio è quello di determinare il tasso di risposta obiettivo (ORR) in soggetti con traslocazioni di FGFR2 sulla base dei risultati del laboratorio centrale di genomica. Il tasso di risposta obiettivo è definito come la proporzione di soggetti che hanno raggiunto una risposta completa (CR, scomparsa di tutte le lesioni target) oppure una risposta parziale (PR, diminuzione =30% nella somma dei diametri più lunghi delle lesioni target) sulla base dei criteri RECIST versione 1.1. La risposta clinica sarà determinata da un comitato indipendente di revisione radiologica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy assessments will be at screening (baseline scan), every 2 cycles (every 6 weeks) for the first 4 cycles, every 3 cycles (every 9 weeks) thereafter
    Le valutazioni dell’efficacia saranno condotte allo screening (scansione basale), ogni 2 cicli (ogni 6 settimane) per i primi 4 cicli e successivamente ogni 3 cicli (ogni 9 settimane).
    E.5.2Secondary end point(s)
    • ORR in subjects with fibroblast growth factor (FGF)/FGFR alterations other than FGFR2 translocations (Cohort B). • ORR in all subjects with FGF/FGFR alterations (Cohorts A and B). • ORR in subjects negative for FGF/FGFR alterations (Cohort C). • Progression-free survival (PFS = first dose to progressive disease [PD] or death; all cohorts). • Duration of response (DOR = time from the date of CR or PR until PD; all cohorts). • Disease control rate (DCR = CR + PR + stable disease; all cohorts). • Overall survival (OS = first dose to death of any cause; all cohorts). • Safety and tolerability will be assessed by evaluating the frequency, duration, and severity of adverse events; through review of findings of physical examinations, changes in vital signs, and electrocardiograms; and through clinical laboratory blood and urine sample evaluations (all cohorts). • Population pharmacokinetics (all cohorts).
    • ORR nei soggetti con alterazioni del fattore di crescita dei fibroblasti (FGF)/FGFR diverse dalle traslocazioni di FGFR2 (Coorte B).
    • ORR in tutti i soggetti con alterazioni di FGF/FGFR (Coorti A e B).
    • ORR in soggetti negativi alle alterazioni FGF/FGFR (Coorte C).
    • Sopravvivenza libera da progressione (PFS = dalla prima dose alla progressione della malattia [PD] o decesso; tutte le coorti).
    • Durata della risposta (DOR = tempo dalla data della CR o PR fino a PD; tutte le coorti).
    • Tasso di controllo della malattia (DCR = CR + PR + malattia stabile; tutte le coorti).
    • Sopravvivenza globale (OS = dalla prima dose al decesso per qualsiasi causa; tutte le coorti).
    • La sicurezza e la tollerabilità saranno valutate misurando la frequenza, la durata e la gravità degli eventi avversi, attraverso la revisione dei risultati degli esami obiettivi, variazioni nei segni vitali ed elettrocardiogramma e attraverso valutazioni cliniche di laboratorio sui campioni di sangue e di urine (tutte le coorti).
    • Farmacocinetica della popolazione (tutte le coorti).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy assessments will be at screening (baseline scan), every 2 cycles (every 6 weeks) for the first 4 cycles, every 3 cycles (every 9 weeks) thereafter. Safety assessment will be at all visits.
    Le valutazioni dell’efficacia saranno condotte allo screening (scansione basale), ogni 2 cicli (ogni 6 settimane) per i primi 4 cicli e successivamente ogni 3 cicli (ogni 9 settimane). La valutazione della sicurezza sarà effettuata in tutte le visite.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Korea, Republic of
    Taiwan
    Thailand
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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 Decision2017-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-29
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