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    Summary
    EudraCT Number:2018-002894-23
    Sponsor's Protocol Code Number:INCB54828-302
    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:2019-05-17
    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 number2018-002894-23
    A.3Full title of the trial
    A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)
    Estudio en fase III, abierto, aleatorizado, multicéntrico y controlado con tratamiento activo para evaluar la eficacia y la seguridad de pemigatinib comparado con quimioterapia con gemcitabina y cisplatino en el tratamiento de primera línea de participantes con colangiocarcinoma no resecable o metastásico con reordenación del FGFR2 (FIGHT-302)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)
    Estudio en fase III, abierto, aleatorizado, multicéntrico y controlado con tratamiento activo para evaluar la eficacia y la seguridad de pemigatinib comparado con quimioterapia con gemcitabina y cisplatino en el tratamiento de primera línea de participantes con colangiocarcinoma no resecable o metastásico con reordenación del FGFR2 (FIGHT-302)
    A.4.1Sponsor's protocol code numberINCB54828-302
    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.5.4Telephone number+34659585029
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2066
    D.3 Description of the IMP
    D.3.1Product nameNot yet available
    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 INNpemigatinib
    D.3.9.1CAS number 1513857-77-6
    D.3.9.2Current sponsor codeINCB054828
    D.3.9.3Other descriptive nameINCB054828
    D.3.9.4EV Substance CodeSUB183791
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpemigatinib
    D.3.9.1CAS number 1513857-77-6
    D.3.9.2Current sponsor codeINCB054828
    D.3.9.3Other descriptive nameINCB054828
    D.3.9.4EV Substance CodeSUB183791
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpemigatinib
    D.3.9.1CAS number 1513857-77-6
    D.3.9.2Current sponsor codeINCB054828
    D.3.9.3Other descriptive nameINCB054828
    D.3.9.4EV Substance CodeSUB183791
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13.5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 122111-03-9
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEMCITABINE
    D.3.9.1CAS number 122111-03-9
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameCisplatin
    D.3.4Pharmaceutical form 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 INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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 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
    Male and female participants at least 18 years of age who have unresectable and/or metastatic cholangiocarcinoma with FGFR2 rearrangement
    Participantes masculinos y femeninos de al menos 18 años de edad con colangiocarcinoma no resecable o metastásico con reordenamiento FGFR2
    E.1.1.1Medical condition in easily understood language
    Participants with advanced cholangiocarcinoma
    Participantes con colangiocarcinoma avanzado
    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
    Evaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants with cholangiocarcinoma with FGFR2 rearrangement.
    Evaluar la eficacia de pemigatinib versus gemcitabina más cisplatino en el tratamiento de primera línea de sujetos con colangiocarcinoma con reordenamiento de FGFR2.
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants with cholangiocarcinoma with FGFR2 rearrangement.
    - Safety and tolerability of pemigatinib.
    - Quality of Life impact.
    -Evaluar la eficacia de pemigatinib versus gemcitabina más cisplatinoen el tratamiento de primera línea de sujetos con colangiocarcinoma con reordenamiento de FGFR2.
    - Seguridad y tolerancia de pemigatinib.
    -Impacto en la calidad de la vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to comprehend and willingness to sign a written ICF for the study.
    2. Male and female participants at least 18 years of age at the time of signing the ICF; a legally minor participant from Japan needs written parental consent.
    3. Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic.
    4. Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.
    5. ECOG performance status 0 to 1.
    6. Documented FGFR2 rearrangement.
    1. Capacidad para comprender y voluntad de firmar un ICF por escrito para el estudio.
    2. Hombres y mujeres participantes de al menos 18 años de edad en el momento de la firma del ICF; un participante menor de edad en Japón necesita consentimiento de los padres por escrito.
    3. Colangiocarcinoma histológica o citológicamente confirmado que no se ha tratado previamente y se considera irresecable y/o metastásico.
    4. Tumor medible o evaluable radiológicamente por TAC o RM según los criterios RECIST v1.1
    5. Estado general 0 o 1 según el ECOG (ver la Tabla 13)
    6. Reordenación del FGFR2 documentada.
    E.4Principal exclusion criteria
    1. Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment).
    2. Child-Pugh B and C.
    3. Toxicities related to prior therapy(ies) must be CTCAE v5.0 ≤ Grade 1 at the time of screening.
    4. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization), other than the therapies being tested in this study.
    5. The participant must not be a candidate for potentially curative surgery.
    6. Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination.
    7. Radiation therapy administered within 4 weeks of enrollment/randomization/ first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval. A 2-week washout is permitted for palliative radiation to non-CNS disease.
    8. Known CNS metastases or history of uncontrolled seizures. Participants with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period, and they are on stable or decreasing dose of corticosteroids for at least 1 week.
    9. Known additional malignancy that is progressing or requires active treatment.
    Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    1. Haber recibido tratamiento antineoplásico sistémico previo para la enfermedad irresecable o metastásica (sin incluir el tratamiento adyuvante/neoadyuvante completado al menos 6 meses antes de la inscripción y los participantes que hayan recibido tratamiento para la enfermedad localmente avanzada con quimioembolización transarterial o radioterapia interna selectiva, si se observan claros indicios de progresión radiológica antes de la inscripción en el estudio).
    2. Child-Pugh B y C.
    3. Las toxicidades relacionadas con tratamientos previos deben ser de grado ≤1, según los CTCAE, v 5.0, en el momento de la selección.
    4. Tratamiento antineoplásico concomitante (p. ej., quimioterapia, radioterapia, cirugía, inmunoterapia, tratamiento biológico, tratamiento hormonal, tratamiento en investigación o embolización del tumor), distinto de los tratamientos que se están probando en este estudio.
    5. El participante no debe ser candidato para cirugía potencialmente curativa.
    6. Pruebas actuales de afección clínicamente significativa de la córnea (incluidas, entre otras, queratopatía bullosa/en banda, abrasión de la córnea, inflamación/ulceración y queratoconjuntivitis) o de la retina (incluidas, entre otras, retinopatía serosa central, degeneración macular/retiniana, retinopatía diabética o desprendimiento de retina) confirmada mediante exploración oftalmológica
    7. Radioterapia administrada en las 4 semanas previas a la inscripción/aleatorización/primera dosis del tratamiento del estudio. Los participantes deben de haberse recuperado de todas las toxicidades relacionadas con la radioterapia, no necesitar corticoesteroides y no haber tenido neumonitis por la radioterapia. Se permiten indicios de fibrosis en un campo de radiación de la radioterapia previa con la aprobación del supervisor médico. Está permitido el reposo farmacológico de 2 semanas para radioterapia paliativa de enfermedad que no sea del SNC.
    8. Presencia conocida de metástasis del SNC o antecedentes de convulsiones no controladas. Los participantes con metástasis cerebrales tratadas son aptos si no hay indicios de progresión durante al menos 4 semanas después del tratamiento dirigido al SNC, determinado por la exploración clínica y por estudios cerebrales por imagen (RM o TAC) durante el periodo de selección, y reciben dosis estables o decrecientes de corticoesteroides durante al menos 1 semana.
    9. Neoplasia maligna adicional conocida, que está progresando o necesita tratamiento activo. Son excepciones el carcinoma basocelular de la piel, el carcinoma de células escamosas de la piel o el cáncer cervical in situ que se haya sometido a tratamiento potencialmente curativo.
    E.5 End points
    E.5.1Primary end point(s)
    PFS: defined as the time from date of randomization until date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first.
    SSP: se define como el tiempo desde la fecha de la aleatorización hasta la fecha de progresión de la enfermedad (según los criterios RECIST v1.1 y evaluada por una RCI) o muerte, lo que ocurra primero.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The schedule for assessments will be performed according to the schedule of activities reported in the protocol.
    The schedule for efficacy assessments will be at screening (this will be considered the baseline scan), every 9 weeks (every 3 cycles) and then at EOT (if applicable). Imaging should continue in 9-week intervals regardless of delays in cycle starts.
    El calendario de evaluaciones se realizará de acuerdo con el calendario de actividades informado en el protocolo.
    El cronograma para las evaluaciones de eficacia será en la selección (esto se considerará la exploración de referencia), cada 9 semanas (cada 3 ciclos) y luego a EOT (si corresponde). Las imágenes deben continuar en intervalos de 9 semanas, independientemente de los retrasos en el inicio del ciclo.
    E.5.2Secondary end point(s)
    • ORR (CR + PR): defined as the proportion of participants with best overall response of CR or PR per RECIST v1.1 as assessed by an ICR.
    • OS: defined as the time from date of randomization until death due to any cause.
    • DOR: defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first.
    • DCR (CR + PR + SD): defined as the proportion of participants who achieved best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR.
    • Occurrence of TEAEs and treatment-related AEs according to NCI CTCAE v5.0, physical findings, and vital sign, laboratory, and ECG changes.
    • QoL questionnaire data (EQ-5D, EORTC QLQ-30, and BIL-21).
    • ORR(RC + RP): se define como la proporción de participantes con mejor respuesta global de RC o RP según los criterios RECIST v1.1 y según la evaluación de una RCI.
    • OS: se define como el tiempo desde la fecha de la aleatorización hasta la fecha de la muerte por cualquier causa.
    • DOR: se define como el tiempo desde la fecha de la primera evaluación de RC o RP hasta la fecha de la primera progresión de la enfermedad por un ICR por RECIST v1.1 o muerte, lo que ocurra primero.
    • DCR (CR + PR + SD): se define como la proporción de participantes que obtuvieron la mejor respuesta general de CR, PR o SD según RECIST v1.1 según lo evaluó un ICR.
    • Aparición de TEAE y efectos adversos relacionados con el tratamiento según NCI CTCAE v5.0, hallazgos físicos y cambios en los signos vitales, el laboratorio y el ECG.
    • Datos del cuestionario QoL (EQ-5D, EORTC QLQ-30 y BIL-21).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The schedule for assessments will be performed according to the schedule of activities reported in the protocol.
    The schedule for efficacy assessments will be at screening (this will be considered the baseline scan), every 9 weeks (every 3 cycles) and then at EOT (if applicable). Imaging should continue in 9-week intervals regardless of delays in cycle starts.
    Adverse events will be monitored from the time the participant signs the ICF until at least 30 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurs first.
    El calendario de evaluaciones se realizará de acuerdo con el calendario de actividades informado en el protocolo.
    El cronograma para las evaluaciones de eficacia será en la selección (esto se considerará la exploración de referencia), cada 9 semanas (cada 3 ciclos) y luego a EOT (si corresponde). Las imágenes deben continuar en intervalos de 9 semanas, independientemente de los retrasos en el inicio del ciclo.
    Los eventos adversos se controlarán desde el momento en que el participante firme el ICF hasta al menos 30 días después de la última dosis de tratamiento del estudio o hasta el inicio de una nueva terapia contra el cáncer, lo que ocurra primero.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA104
    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
    Belgium
    Denmark
    Finland
    France
    Germany
    Ireland
    Israel
    Italy
    Japan
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    External DMC
    External DMC
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 172
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 432
    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)
    Participants who progress while receiving gemcitabine plus cisplatin are eligible to receive second-line treatment with pemigatinib under the crossover part of this study. Participants that do not wish to participate in the crossover part of this study should be treated according to standard of care and according to disease treatment guidelines.
    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 Decision2019-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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