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    Summary
    EudraCT Number:2016-001321-14
    Sponsor's Protocol Code Number:INCB54828-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-001321-14
    A.3Full title of the trial
    A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations
    Estudio en fase II, abierto, en monoterapia y multicéntrico para evaluar la
    eficacia y la seguridad de INCB054828 en sujetos con carcinoma urotelial
    metastásico o irresecable quirúrgicamente portador de alteraciones del
    FGF/FGFR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open-Label, Single-Agent, Multicenter Study to investigate the Efficacy and Safety of INCB054828 in Subjects Advanced Bladder cancer with FGF/FGFR Alterations
    Estudio en fase II, abierto, en monoterapia y multicéntrico para evaluar la
    eficacia y la seguridad de INCB054828 en sujetos con carcinoma urotelial
    metastásico o irresecable quirúrgicamente portador de alteraciones del
    FGF/FGFR
    A.4.1Sponsor's protocol code numberINCB54828-201
    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 Corporation
    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 number+34948255 400
    B.5.6E-mailRegAffairs@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.3.8INN - Proposed INNINCB054828
    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 4.5
    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 metastatic or surgically unresectable urothelial cancer (may include primary site from ureters, upper tract, renal pelvis, and bladder) with an FGF/FGFR alteration, who failed at least 1 previous treatment or are platinum ineligible.
    Sujetos con Carcinoma urotelial metastásico o irresecable
    quirúrgicamente ( se podrán incluir ubicaciones primarias de los
    uréteres, el tracto superior, la pelvis renal y la vejiga) portadores de una
    alteración del FGF/FGFR que no hayan respondido al menos a 1
    tratamiento anterior o no sean aptos para la quimioterapia con platino.
    E.1.1.1Medical condition in easily understood language
    Subjects with advanced bladder cancer with an FGF/FGFR abnormality.
    Sujetos con cáncer de vejiga avanzado con alteraciones de FGF/FGFR.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    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 evaluate the overall response rate (ORR) of INCB054828 as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) alterations.
    Evaluar la tasa de respuesta general (TRG) de INCB054828 en
    monoterapia en el tratamiento contra el carcinoma urotelial metastásico
    o irresecable quirúrgicamente portador de alteraciones del factor de
    crecimiento de los fibroblastos (FGF)/receptor del factor de crecimiento
    de los fibroblastos (FGFR).
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of INCB054828.
    • To evaluate other clinical efficacy measurements, including duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
    v Evaluar la seguridad y la tolerabilidad de INCB054828.
    • Evaluar otras medidas de la eficacia clínica, incluidas la duración de la
    respuesta (DR), la supervivencia sin progresión (SSP) y la supervivencia
    general (SG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women, aged 18 or older.
    • Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from ureters, upper tract, renal pelvis, and bladder.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
    • Life expectancy ≥ 12 weeks.
    • Radiographically measurable or evaluable disease per RECIST v1.1.
    • Known FGF/FGFR alteration from the sponsor's central laboratory and have either:
    − have failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy), or
    − have not received chemotherapy for metastatic or surgically unresectable urothelial carcinoma due to poor performance status (ie, ECOG performance status of 2) and insufficient renal function (ie, creatinine clearance < 60 mL/min or local guidelines).
    • Willingness to avoid pregnancy or fathering children.
    • Hombres y mujeres mayores de edad.
    • Carcinoma urotelial metastásico o irresecable quirúrgicamente,
    documentado histológicamente; se podrán incluir ubicaciones primarias
    de los uréteres, el tracto superior, la pelvis renal y la vejiga.
    • Estado general de 0, 1 o 2 del Grupo Oncológico Cooperativo del Este
    (ECOG).
    • Esperanza de vida ≥12 semanas.
    • Enfermedad medible o evaluable radiográficamente según los RECIST
    v1.1.
    • Alteración conocida del FGF/FGFR detectada en el laboratorio central
    del promotor y que:
    −no ha respondido al menos a 1 tratamiento anterior contra el
    carcinoma urotelial metastásico o irresecable quirúrgicamente (p. ej.,
    quimioterapia o inmunoterapia), o
    −no ha recibido quimioterapia para el tratamiento del carcinoma
    urotelial metastásico o irresecable quirúrgicamente debido a un mal
    estado general (es decir, estado general según el ECOG de 2) y a
    insuficiencia renal (es decir, aclaramiento de creatinina <60 ml/min o
    según las directrices locales).
    • Disposición a evitar quedarse embarazada o a engendrar hijos.
    E.4Principal exclusion criteria
    • Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) before first dose of study drug. Subjects must have recovered (Grade ≤ 1 or at pretreatment baseline) from AEs from previously administered therapies.
    • Prior receipt of a selective FGFR inhibitor.
    • Abnormal laboratory parameters:
    − Total bilirubin ≥ 1.5 × upper limit of normal (ULN; ≥ 2.5 × ULN if Gilbert syndrome or metastatic disease involving liver).
    − Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 × ULN (AST and ALT > 5 × ULN in the presence of liver metastases).
    − Creatinine clearance ≤ 30 mL/min based on Cockroft-Gault.
    − Serum phosphate > institutional ULN.
    − Serum calcium outside of the institutional normal range or serum albumin-corrected calcium outside of the institutional normal range when serum albumin is outside of the institutional normal range.
    • 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.
    • Known hypersensitivity or severe reaction to INCB054828 or excipients of INCB054828 study drug.
    • Inability or unwillingness to swallow INCB054828 or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of INCB054828.
    • Subjects who require hemodialysis.
    cualquier indicación por cualquier motivo o administración de
    medicamentos antineoplásicos en los 21 días o 5 semividas (lo que dure
    más) anteriores a la administración de la primera dosis del fármaco del
    estudio. Los sujetos deben haberse recuperado (grado ≤1 o valores
    iniciales previos al tratamiento) de AA derivados de tratamientos
    anteriores.
    • Administración previa de un inhibidor selectivo del FGFR.
    • Parámetros analíticos anómalos:
    − Bilirrubina total ≥1,5 × límite superior de la normalidad (LSN; ≥2,5 ×
    LSN si se aprecia síndrome de Gilbert o enfermedad metastásica que
    afecte al hígado).
    − Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT)
    >2,5 × LSN (AST y
    ALT >5 × LSN en presencia de metástasis hepática).
    − Aclaramiento de creatinina ≤30 ml/min según la fórmula de Cockroft-
    Gault.
    − Fosfato sérico >LSN institucional.
    − Calcio sérico fuera del intervalo normal institucional o calcio sérico
    corregido por albúmina fuera del intervalo normal institucional cuando la
    albúmina sérica se encuentra fuera del intervalo normal institucional.
    • Uso de cualquier inductor o inhibidor de CYP3A4 potente en los 14 días
    o 5 semividas (lo que dure menos) anteriores a la administración de la
    primera dosis del fármaco del estudio.
    • Hipersensibilidad o reacción intensa conocida a INCB054828 o los
    excipientes del fármaco del estudio INCB054828.
    • Incapacidad o falta de disposición para ingerir INCB054828 o
    trastornos gastrointestinales significativos que puedan interferir en la
    absorción, el metabolismo o la excreción de INCB054828.
    • Sujetos que requieren hemodiálisis
    E.5 End points
    E.5.1Primary end point(s)
    • Overall response rate based on review of scans by an independent centralized radiological review committee.
    Tasa de respuesta general en base a la revisión de exploraciones por
    escáner por un comité de revisión radiológica centralizado
    independiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR, (complete response or partial response) by RECIST v1.1.with efficacy assessments every 9 weeks (every 3 cycles) throughout the study.
    TRG (respuesta completa o respuesta parcial) por RECIST v1.1 con
    evaluaciones de eficacia cada 9 semanas ( cada 3 ciclos) durante todo el
    estudio.
    E.5.2Secondary end point(s)
    • Progression-free survival.
    • Duration of response.
    • Overall survival.
    • Safety and tolerability, assessed by evaluating the frequency, duration, and severity of adverse events (AEs).
    • Duración de la respuesta.
    • Supervivencia general.
    • Seguridad y tolerabilidad, analizadas según la evaluación de la
    frecuencia, la duración y la intensidad de acontecimientos adversos
    (AA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression-free survival is defined as number of days from the first day of taking study drug dose to the earlier of death or disease progression by RECIST v1.1 as assessed by the central.
    Overall survival is defined as the number of days from the first day taking study drug dose to death due to any cause.
    The DOR is defined as the number of days from the date of the first confirmed response to the date of the first documented evidence of disease progression or death.
    desde el primer día de la administración de la primera dosis hasta el
    anterior de la muerte o la progresión de la enfermedad por RECIST v1.1
    según lo evaluado en el central.
    La respuesta general se define como el número de días desde el primer
    día de la administración de la primera dosis hasta la muerte por
    cualquier causa.
    La duración de la respuesta(DR) se definirá a partir de la fecha de la
    primera respuesta confirmada hasta la fecha de la primera prueba
    documentada de progresión de la enfermedad o muerte.
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    Israel
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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
    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 Decision2016-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-01
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