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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2019-001925-28
    Sponsor's Protocol Code Number:FGCL-3019-087
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2020-01-14
    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 number2019-001925-28
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in combination with Gemcitabine Plus Nab-paclitaxel as Neoadjuvant Treatment in Patients with Locally Advanced, Unresectable Pancreatic Cancer
    Estudio de fase III, aleatorizado y doble ciego de pamrevlumab o placebo en combinación con gemcitabina más nab-paclitaxel como tratamiento neoadyuvante en pacientes con cáncer pancreático localmente avanzado irresecable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Pamrevlumab or placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Locally Advanced Pancreatic Cancer
    Estudio de pamrevlumab o placebo en combinación con quimioterapia como tratamiento neoadyuvante en casos de cáncer pancreático localmente avanzado irresecable
    A.3.2Name or abbreviated title of the trial where available
    Not available
    A.4.1Sponsor's protocol code numberFGCL-3019-087
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03941093
    A.5.4Other Identifiers
    Name:IND numberNumber:011952
    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 SponsorFibroGen, Inc.
    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 supportFibroGen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFibroGen, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address409 Illinois Street
    B.5.3.2Town/ citySan Francisco, California
    B.5.3.3Post code94158
    B.5.3.4CountryUnited States
    B.5.6E-mail3019-087Study@Fibrogen.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.3.1Product namePamrevlumab
    D.3.2Product code FG-3019
    D.3.4Pharmaceutical form 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 INNPAMREVLUMAB
    D.3.9.1CAS number 946415-13-0
    D.3.9.2Current sponsor codeFG-3019
    D.3.9.3Other descriptive namePamrevlumab
    D.3.9.4EV Substance CodeSUB198085
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced, Unresectable Pancreatic Cancer
    Cáncer pancreático localmente avanzado irresecable
    E.1.1.1Medical condition in easily understood language
    Cancer of the pancreas
    Cáncer de pancreas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033606
    E.1.2Term Pancreatic cancer non-resectable
    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
    To evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab in combination with gemcitabine plus nab-paclitaxel when compared to treatment with gemcitabine plus nab-paclitaxel alone in locally advanced, unresectable pancreatic cancer.
    Evaluar la eficacia y la seguridad del tratamiento neoadyuvante con pamrevlumab en combinación con gemcitabina más nab-paclitaxel en comparación con el tratamiento con gemcitabina más nab-paclitaxel solamente, en cáncer pancreático localmente avanzado irresecable.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of neoadjuvant treatment with pamrevlumab in combination with gemcitabine plus nab-paclitaxel or gemcitabine plus nab-paclitaxel alone on resection rates.
    Evaluar el efecto del tratamiento neoadyuvante con pamrevlumab en combinación con gemcitabina más nab-paclitaxel o del tratamiento solo con gemcitabina más nab-paclitaxel sobre las tasas de resección.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Understand and sign informed consent; be willing to comply with study procedures, including surgery
    2. Age ≥ 18 years
    3. Be a male, or non-pregnant and non-lactating female
    4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential
    5. Male subjects with partners of childbearing potential and female subjects of childbearing potential are required to use double barrier contraception methods during the conduct of the study and for 3 months after the last dose of study drug
    6. Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
    7. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging
    8. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria as determined by central imaging
    9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    10. Adequate liver function
    11. Adequate bone marrow function
    12. Adequate renal function
    13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)
    1. Comprender y firmar el consentimiento informado; estar dispuesto a cumplir los procedimientos del estudio, incluida la intervención quirúrgica.
    2. Edad ≥18 años.
    3. Ser hombre o mujer no embarazada ni lactante.
    4. Prueba de embarazo beta-hCG en suero negativa en la selección en mujeres en edad de concebir.
    5. Los pacientes de sexo masculino que tengan parejas con capacidad de concebir y las pacientes de sexo femenino con capacidad de concebir deben utilizar métodos anticonceptivos de doble barrera durante el ensayo y durante 3 meses después de la última dosis del fármaco del ensayo.
    6. Diagnóstico de adenocarcinoma ductal pancreático (ACDP) demostrado por estudio histológico.
    7. Cáncer pancreático localmente avanzado considerado irresecable según la evaluación del laboratorio central de radiodiagnóstico de acuerdo con las guías de la NCCN®, versión 2.2018.
    8. Enfermedad medible determinada por el laboratorio central de radiodiagnóstico según la definición de los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) 1.1.
    9. Estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0 o 1.
    10. Función hepática adecuada.
    11. Función de la médula ósea adecuada.
    12. Función renal adecuada.
    13. Neuropatía periférica preexistente de grado inferior a 2 (según CTCAE).
    E.4Principal exclusion criteria
    1. Prior chemotherapy or radiation for pancreatic cancer
    2. Previous (within the past 3 years) or concurrent malignancy diagnosis except non melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
    3. Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.
    4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
    5. Any medical or surgical condition that may place the subject at increased risk while on study
    6. Any condition potentially decreasing compliance to study procedures
    7. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half lives of the investigational drug (whichever is longer)
    8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    9. Documented history of drug or alcohol abuse within 6 months of signing informed consent
    10. Any medical condition that, in the opinion of the investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation
    1. Quimioterapia o radioterapia previa para el cáncer pancreático.
    2. Diagnóstico de neoplasia maligna concomitante o anterior (en los últimos 3 años), excepto cáncer de piel distinto del melanoma y carcinomas in situ (salvo cáncer de mama in situ).
    3. Intervención de cirugía mayor en las 4 semanas antes de firmar el formulario de consentimiento informado. Se permiten las endoprótesis biliares.
    4. Antecedentes de alergia o hipersensibilidad a anticuerpos monoclonales humanos, humanizados o quiméricos.
    5. Cualquier afección médica o quirúrgica que pueda poner al sujeto en un mayor riesgo mientras esté en el estudio.
    6. Cualquier afección que pueda reducir el cumplimiento de los procedimientos del estudio.
    7. Exposición a otro fármaco en investigación en los 28 días posteriores a la primera visita de administración o 5 semividas del fármaco en investigación (el periodo más largo).
    8. Enfermedad intercurrente no controlada, incluidas, entre otras, infecciones sistémicas persistentes o activas, insuficiencia cardíaca congestiva sintomática, angina de pecho inestable, arritmia cardíaca clínicamente significativa o situaciones psiquiátricas/sociales que limitarían el cumplimiento de los requisitos del estudio.
    9. Antecedentes documentados de abuso de drogas o alcohol en los 6 meses posteriores al consentimiento informado
    10. Cualquier afección médica que el investigador considere que pueda suponer un riesgo de seguridad para un sujeto en este ensayo, pueda dificultar la evaluación de la seguridad y la eficacia, o pueda interferir con la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS)
    Supervivencia global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to death due to any cause.
    Tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa.
    E.5.2Secondary end point(s)
    Progression-free survival (PFS), defined as the time from randomization until objective tumor progression or death (whichever occurs first).
    Change in Patient Reported Outcomes (PROs) as measured by:
    - Mean change from baseline during the treatment period in physical function by EORTC-QLQ-C30.
    - Mean change from baseline during the treatment period in abdominal pain by NCI-PRO-CTCAE.
    - Mean change from baseline during the treatment period in fatigue by NCI-PRO-CTCAE.
    Supervivencia sin progresión (SSP), definida como el tiempo transcurrido desde la aleatorización hasta la progresión tumoral objetiva o la muerte (lo que suceda antes).
    Cambio en los resultados notificados por el paciente (RNP) medido a través de lo siguiente:
    -Cambio medio durante el período de tratamiento con respecto al inicio en el funcionamiento físico según el cuestionario QLQ-C30 de la EORTC.
    -Cambio medio durante el período de tratamiento con respecto al inicio en el dolor abdominal según el sistema PRO-CTCAE del NCI.
    -Cambio medio durante el período de tratamiento con respecto al inicio en la fatiga según el sistema PRO-CTCAE del NCI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time-to-event endpoints will be analyzed using the same methods used in the analysis of OS. For dichotomous secondary endpoints, CMH test controlling for stratification factors will be used to compare the treatment groups. For continuous endpoints, analysis of covariance with the baseline value as the covariate will be used. All analyses will be adjusted for the randomization stratification factors.
    Los criterios de valoración del intervalo de tiempo hasta que ocurra el acontecimiento se analizarán utilizando los mismos métodos utilizados en el análisis de la SG. Para los criterios de valoración secundarios dicotómicos, se utilizará la prueba de CMH que controla los factores de estratificación para comparar los grupos de tratamiento. Para los criterios de valoración continuos, se utilizará el análisis de la covarianza con el valor inicial como covariable. Todos los análisis se ajustarán en función de los factores de estratificación de la aleatorización.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Australia
    Austria
    Belgium
    Canada
    China
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Spain
    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
    LSLV
    All subjects will be followed for survival (until death or until the last subject to complete treatment reaches 18 months post-treatment).
    USUV
    Se realizará un seguimiento de la supervivencia de todos los pacientes (hasta la muerte o hasta que el último paciente que finalice el tratamiento alcance los 18 meses de postratamiento).
    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 months3
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 60
    F.4.2.2In the whole clinical trial 256
    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)
    Subjects participation will continue in the follow-up period beyond their completion of treatment. All subjects will be followed for progression, any additional anti-cancer therapy received and survival until death or until the last subject completes 18 months follow-up.
    La participación de los sujetos continuará en el periodo de seguimiento más allá de la finalización del tratamiento. Se hará un seguimiento de todos los pacientes en cuanto a la progresión, cualquier tratamiento antineoplásico adicional recibido y la supervivencia hasta la muerte o hasta que el último sujeto finalice el seguimiento de 18 meses.
    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 Decision2020-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-30
    P. End of Trial
    P.End of Trial StatusRestarted
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