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    Summary
    EudraCT Number:2017-003507-22
    Sponsor's Protocol Code Number:FPA144-004
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-25
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2017-003507-22
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 2 Preceded by Dose-Finding in Phase 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase I to be conducted prior to Phase 2
    A.3.2Name or abbreviated title of the trial where available
    FIGHT
    A.4.1Sponsor's protocol code numberFPA144-004
    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 SponsorFive Prime Therapeutics, 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 supportFive Prime Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFive Prime Therapeutics, Inc.
    B.5.2Functional name of contact pointMedical Lead
    B.5.3 Address:
    B.5.3.1Street Address111 Oyster Point Boulevard
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1844333-5349
    B.5.6E-mailFPA144004@fiveprime.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 namebemarituzumab
    D.3.2Product code FPA144
    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 INNbemarituzumab
    D.3.9.2Current sponsor codeFPA144
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Advanced Gastric and Gastroesophageal Cancer
    E.1.1.1Medical condition in easily understood language
    Advanced Gastric and Gastroesophageal Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric 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 compare Investigator-assessed progression-free survival (PFS) in patients with FGFR2-selected GC treated with FPA144 + mFOLFOX6 to those treated with placebo combined with mFOLFOX6 (hereinafter referred to as [placebo +mFOLFOX6])
    E.2.2Secondary objectives of the trial
    To compare the following in patients with FGFR2-selected GC treated with FPA144 + mFOLFOX6 to those treated with placebo + mFOLFOX6:
    • Overall survival (OS)
    • Investigator-assessed objective response rate (ORR)
    • Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase 1 and Phase 2:

    1. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
    2. Understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF prior to any study-specific evaluation
    3. Life expectancy of at least 3 months in the opinion of the investigator
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    5. Age ≥ 18 years at the time the ICF is signed
    6. In sexually active patients (women of child bearing potential [WOCBP] and males), willingness to use 2 effective methods of contraception, of which 1 must be a physical barrier method (condom, diaphragm, or cervical/vault cap) until 6 months after the last dose of FPA144. Other effective forms of contraception include:
    • Permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to screening
    • WOCBP who are on stable oral contraceptive therapy or intrauterine or implant device for at least 90 days prior to the study, or abstain from sexual intercourse as a way of living
    7. Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:
    Bone Marrow Function
    • ANC ≥ 1.5 × 109/L
    • Platelets ≥ 100 × 109/L
    • Hemoglobin ≥ 9 g/dL
    Hepatic Function
    • AST and ALT < 3 × ULN; if liver metastases, then < 5 × ULN
    • Bilirubin < 1.5 × ULN except in patients with Gilbert’s disease
    Renal Function
    • Calculated CrCl using Cockcroft Gault formula ≥ 50 mL/min or
    estimated glomerular filtrate rate (eGFR) using the Chronic Kidney
    Disease Epidemiology Collaboration (CKD-EPI) formula ≥ 50 mL/min
    8. INR or prothrombin time (PT) < 1.5 × the ULN except for patients receiving anticoagulation, who must be on a stable dose of warfarin for 6 weeks prior to enrollment
    9. Measurable or non-measurable, but evaluable disease using RECIST v1.1

    Additional Inclusion Criteria for Phase 2 Only:
    • Histologically documented gastric or gastroesophageal junction (GEJ) adenocarcinoma (not amenable to curative therapy)
    • Radiographic imaging of the chest, abdomen and pelvis (computed tomography [CT] preferred, magnetic resonance imaging [MRI] acceptable) performed within 28 days (+ 3 days) of treatment (C1D1)
    • FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay
    • Patient must be a candidate for mFOLFOX6 chemotherapy
    • No prior chemotherapy for metastatic or unresectable disease (except a maximum of 1 dose of mFOLFOX6 administered while waiting for results of FGFR2 testing during the Pre-Screening period)
    • If prior adjuvant or neo-adjuvant therapy (chemotherapy and/or chemoradiation) has been received, more than 6 months must have elapsed between the end of adjuvant therapy and the confirmation of radiographic disease progression
    E.4Principal exclusion criteria
    Phase 1 and Phase 2:

    1. Untreated or symptomatic central nervous system (CNS) metastases (CNS imaging not required). Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks and do not require intervention such as surgery, radiation, or any corticosteroid therapy for management of symptoms related to CNS disease
    2. Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g):
    a) Unstable angina pectoris ≤ 6 months prior to enrollment
    b) Acute myocardial infarction ≤ 6 months prior to enrollment
    c) New York Heart Association Class II-IV congestive heart failure
    d) Uncontrolled hypertension (as defined as ≥ 160/90 despite optimal medical management)
    e) Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
    f) Active coronary artery disease
    g) Fridericia’s correction formula (QTcF) ≥ 480
    3) Peripheral sensory neuropathy ≥ CTCAE Grade 2
    4. Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to enrollment
    5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
    6. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
    7. Evidence or history of bleeding diathesis or coagulopathy
    8. Radiotherapy ≤ 28 days of enrollment. Patients must be recovered from all acute radiotherapy-related toxicities. No radiopharmaceuticals (strontium, samarium) within 8 weeks of enrollment
    9. Prior treatment with any selective inhibitor (eg, AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
    10. Ongoing adverse effects from prior systemic treatment > NCI CTCAE Grade 1 (with the exception of Grade 2 alopecia and anemia)
    11. Participation in another therapeutic clinical study or receiving any investigational agent within 28 days of enrollment or during this clinical study
    12. Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
    13. Known positivity for HER2 (as defined by a positive IHC test of 3+ or IHC of 2+ with fluorescent in situ hybridization [FISH])
    14. Major surgical procedures not permitted ≤ 28 days prior to enrollment. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before enrollment. In all cases, the patient must be sufficiently recovered and stable before treatment administration
    15. Women who are pregnant or breastfeeding (unless the patient is willing to interrupt breastfeeding during study treatment administration and then resume 6 months after study discontinuation); WOCBP must not consider getting pregnant during the study
    16. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including arterial thrombosis, or symptomatic pulmonary embolism)
    17. Presence of any other condition that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry in the study
    18. Known allergy, hypersensitivity or contraindication to components of the FPA144 formulation including polysorbate or to platinum-containing medications, 5-FU, or leucovorin
    19. History of prior malignancy, except (Criteria a through f):
    a) Curatively treated non-melanoma skin malignancy
    b) Cervical cancer in situ
    c) Curatively treated Stage I uterine cancer
    d) Curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy
    e) Localized prostate cancer that has been treated surgically with curative intent and presumed cured
    f) Solid tumor treated curatively more than 5 years previously without evidence of recurrence
    E.5 End points
    E.5.1Primary end point(s)
    Investigator-assessed progression-free survival (PFS) defined as time from randomization until the date of disease progression based on
    investigator assessment (using RECIST v1.1) or death from any cause, whichever comes first
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiological/Tumor Assessment: Screening, every 8 weeks from C1D1 until 12 months and then every 12 weeks thereafter, EOT, follow-up (if
    applicable)
    E.5.2Secondary end point(s)
    • Overall survival (OS), defined as time from randomization until death from any cause
    • Objective response rate (ORR), defined as the proportion of patients with partial or complete response in all enrolled patients based on investigator assessment of tumor lesions per RECIST v1.1
    • Incidence of AEs, clinical laboratory abnormalities, corneal and retinal findings, and ECG abnormalities
    E.5.2.1Timepoint(s) of evaluation of this end point
    •OS: Every 3 months ± 1 month after the EoT visit until up to 24 months after the last patient is enrolled in the study, or until death, loss to
    follow-up, withdrawal of consent or study termination by the Sponsor (whichever occurs first).
    •AEs: throughout the study
    •Laboratory Evaluations: screening; C1D1, C1D8, C2D1, C3D1, C4D1, EoT and as clinically indicated
    •Vital signs: screening; C1D1, C1D8, C2D1, C3D1, C4D1, EoT; follow-up and as clinically indicated
    •Ophthalmologic Examination: Screening, every 8 weeks from C1D1, EOT
    •Slit Lamp Examination: Week 16 and then every 8 weeks through EOT, as clinically indicated, including after EOT
    •ECG: screening, EoT, as clinically indicated

    Where:
    C1, C2 = Cycle 1, Cycle 2 etc
    D1, D2 = Day 1, Day 2 etc
    EoT = End of Treatment
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity, tolerability
    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 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 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 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 concerned8
    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
    China
    Japan
    Korea, Republic of
    Taiwan
    Turkey
    United States
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Romania
    Spain
    United Kingdom
    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
    24 months after the last patient is enrolled in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 117
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 167
    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 Decision2019-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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