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    Summary
    EudraCT Number:2019-001925-28
    Sponsor's Protocol Code Number:FGCL-3019-087
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-11
    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 ConcernedAustria - BASG
    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 either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients with Locally Advanced, Unresectable Pancreatic Cancer
    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
    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
    E.1.1.1Medical condition in easily understood language
    Cancer of the 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 either gemcitabine plus nab-paclitaxel or FOLFIRINOX when compared to treatment with gemcitabine plus nab-paclitaxel alone in locally advanced, unresectable pancreatic cancer.
    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.
    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 highly effective contraception methods during the conduct of the study and for 6 months after the last dose of study drug
    6. Histologically or cytologically 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)
    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. History of allergy or hypersensitive to any of the chemotherapy agents being prescribed or their excipients
    6. Any medical or surgical condition that may place the subject at increased risk while on study
    7. Any condition potentially decreasing compliance to study procedures
    8. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half lives of the investigational drug (whichever is longer)
    9. 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
    10. Documented history of drug or alcohol abuse within 6 months of signing informed consent
    11. 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
    12. Subjects with a history of interstitial pulmonary disease, HCV, HBV or HIV infection
    13. Subjects who have been administered a live vaccine within four weeks prior to the first administration of therapy
    14. Subjects who cannot stop chronic medications that inhibit or induce CYP2C8 or CYP3A4
    15. Subjects with poorly controlled comorbid conditions, including congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) or limited functions
    E.5 End points
    E.5.1Primary end point(s)
    - Overall survival (OS)
    - Key Secondary Endpoint - Event-Free Survival (EFS) for Accelerated Approval
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Time from randomization to death due to any cause.
    - The EFS endpoint would be a composite time-to-event endpoint, the event being 'treatment failure' defined as the earliest occurrence of:
    - Failure to archive disease-free status locally after completion of neoadjuvant treatment and / or after surgery (i.e., resection failure or progression that precludes surgery)
    - local or distant recurrence, or
    -Death
    E.5.2Secondary end point(s)
    - Progression-free survival (PFS)

    - RECIST 1.1 - Best Overall objective Response Rate (ORR), defined as the proportion of patients who achieve CR (Complete Response) or PR (Partial Response) during treatment period
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analysis of Progression-free Survival (PFS)

    PFS is defined as the time from randomization until disease progression or death, whichever occurs first.

    Analysis of Best Overall Objective Response Rate (ORR)
    Best overall objective response rate (ORR) is one of the secondary endpoints where objective response is defined as a complete response (CR) or partial response (PR) according to RECIST 1.1.

    Detailed information is summarized within the protocol.
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    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 has been followed for approximately 18 months post-last dose.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 280
    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. During this time, there are no restrictions to the adjuvant or second line therapy prescribed by their treating physicians. There are no plans for continuing treatment or care once their participation in the trial has ended.
    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 Decision2020-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
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