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    Summary
    EudraCT Number:2016-002596-10
    Sponsor's Protocol Code Number:INCB54828-203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002596-10
    A.3Full title of the trial
    A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
    Estudio de fase II abierto y multicéntrico de una monoterapia para evaluar la eficacia y la seguridad del INCB054828 en sujetos con neoplasias mieloides/linfoides con reordenamiento del FGFR1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
    Estudio de fase II abierto y multicéntrico de una monoterapia para evaluar la eficacia y la seguridad del INCB054828 en sujetos con neoplasias mieloides/linfoides con reordenamiento del FGFR1
    A.4.1Sponsor's protocol code numberINCB54828-203
    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 codeDE 19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeINCB054828
    D.3.9.3Other descriptive nameNA
    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
    Lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation
    Neoplasia linfoide o mieloide documentada con reordenamiento de 8p11 que se sabe causa la activación del FGFR1
    E.1.1.1Medical condition in easily understood language
    Lymphoid or myeloid neoplasm with 8p11 rearrangement
    Neoplasia linfoide o mieloide documentada con reordenamiento de 8p11
    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
    The primary objective of this study is to evaluate the efficacy of INCB054828 in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.
    El objetivo principal de este estudio es evaluar la eficacia del INCB054828 en sujetos con neoplasias mieloides/linfoides con reordenamiento del receptor del factor de crecimiento de fibroblastos
    (FGFR) 1.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety of INCB054828 in subjects with myeloid/lymphoid neoplasms with FGFR1 rearrangement.
    El objetivo secundario es evaluar la seguridad del INCB054828 en sujetos con neoplasias mieloides/linfoides con reordenamiento del FGFR1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women, aged 18 or older.
    • Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
    • Only subjects who are not candidates for stem cell transplantation, or have relapsed after stem cell transplantation and delayed lymphocyte infusion and who have progressed and are not candidates for other disease-modifying therapies are eligible for the study. All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
    • Life expectancy ≥ 12 weeks.
    • ECOG performance status 0 to 2.
    • Hombres y mujeres de al menos 18 años de edad.
    • Neoplasia linfoide o mieloide documentada con reordenamiento de 8p11 que se sabe causa la activación del FGFR1, basada en una evaluación citogenética diagnóstica estándar realizada localmente, antes de la firma del consentimiento informado para este estudio.
    • Solo son aptos para el estudio los sujetos que no sean candidatos para el trasplante de células madre, o hayan recaído tras un trasplante de células madre e infusión diferida de linfocitos, y que hayan progresado y no sean candidatos para otros tratamientos modificadores de la enfermedad. Todos los sujetos que hayan recaído o no respondan al tratamiento deben presentar evidencia de enfermedad citogenética o hematológica y ninguna evidencia de toxicidad residual (p. ej., enfermedad de injerto contra huésped que requiera tratamiento).
    • Esperanza de vida ≥ 12 semanas.
    • Estado funcional ECOG de 0 o 2.
    E.4Principal exclusion criteria
    • Prior receipt of a selective FGFR inhibitor.
    • History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
    • Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
    • Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
    • Recepción de un inhibidor selectivo del FGFR en el pasado.
    • Antecedentes y/o evidencia actual de mineralización/calcificación ectópica incluyendo, entre otros, tejidos blandos, riñones, intestino, miocardio o pulmones, excepto por los ganglios linfáticos calcificados y las calcificaciones asintomáticas arteriales o de cartílago/tendón.
    • Evidencia actual de disfunción corneal/queratopatía incluyendo, entre otras, queratopatía bullosa/en banda, abrasión corneal, ulceración/inflamación y queratoconjuntivitis, confirmada mediante examen oftalmológico.
    • Uso de algún inhibidor o inductor potente del citocromo P450 3A4 en los 14 días o las 5 semividas (lo que sea más breve) anteriores a la primera dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to determine the overall clinical benefit rate by achieving 1 of the following: complete response (CR), partial response (PR), complete hematologic response (CHR), cytogenetic response, marrow response, or clinical benefit.
    El criterio principal de valoración de este estudio es determinar la tasa de beneficio clínico global mediante la consecución de 1 de las respuestas siguientes: respuesta completa (RC), respuesta parcial (RP), respuesta hematológica completa (RHC), respuesta citogenética, respuesta medular o beneficio clínico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Bone marrow biopsies or aspirates will be obtained before randomization and then every 3 cycles starting from Cycle 2 Day 1. After the first 12 months of treatment, a bone marrow biopsy or aspirate will be obtained every 6 cycles for subjects who have not yet achieved complete cytogenic response (CCyR) or every 12 cycles if the subject has a confirmed CCyR until Month 24. Following Month 24, a bone marrow biopsy or aspirate will be obtained every 12 months until disease progression or end of treatment.
    Bone marrow biopsies or aspirates will be obtained before randomization and then every 3 cycles starting from Cycle 2 Day 1. After the first 12 months of treatment, a bone marrow biopsy or aspirate will be obtained every 6 cycles for subjects who have not yet achieved complete cytogenic response (CCyR) or every 12 cycles if the subject has a confirmed CCyR until Month 24. Following Month 24, a bone marrow biopsy or aspirate will be obtained every 12 months until disease progression or end of treatment.
    E.5.2Secondary end point(s)
    • Duration of response/benefit.
    • Progression-free survival.
    • Overall survival.
    • Safety and tolerability, as assessed by evaluating the frequency, duration, and severity of adverse events; through review of findings of physical examinations, changes in vital signs, and electrocardiograms (ECGs); and through clinical laboratory blood and urine sample evaluations.
    • Duración de la respuesta/beneficio.
    • Supervivencia sin progresión.
    • Supervivencia global.
    • Seguridad y tolerabilidad, determinadas mediante la evaluación de la frecuencia, el tiempo de evolución y la intensidad de los acontecimientos
    adversos; la revisión de los hallazgos de las exploraciones físicas, las alteraciones de las constantes vitales y los electrocardiogramas (ECG); y las evaluaciones analíticas de muestras de sangre y orina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 3 cycles starting from Cycle 2 Day 1. After the first 12 months of treatment, a bone marrow biopsy or aspirate will be obtained every 6 cycles for subjects who have not yet achieved complete cytogenic response (CCyR) or every 12 cycles if the subject has a confirmed CCyR until Month 24. Following Month 24, a bone marrow biopsy or aspirate will be obtained every 12 months until disease progression or end of treatment
    Cada 3 ciclos a partir de Ciclo 2 Día 1. Después de los primeros 12 meses de tratamiento, se obtendrá una biopsia de médula ósea o de aspirado
    de cada 6 ciclos de sujetos que no tengan aún una respuesta citogenética completa (RCyC) o cada 12 ciclos si el sujeto tiene una respuesta citogenética completa confirmada hasta el mes 24. Tras Mes
    24, una biopsia de médula ósea o de aspirado se obtiene cada 12 meses hasta la progresión de la enfermedad o el final del tratamiento
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Austria
    France
    Germany
    Italy
    Spain
    Switzerland
    United Kingdom
    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
    UVUS
    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 months5
    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 months3
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 46
    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
    Ninguno
    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 Decision2017-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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