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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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:2015-001526-42
    Sponsor's Protocol Code Number:GS-US-296-1080
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-05
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-001526-42
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined with mFOLFOX6 as First Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to evaluate the efficacy and safety of GS-5745 in combination with standard of care in patients with stomach cancer.
    A.4.1Sponsor's protocol code numberGS-US-296-1080
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02545504
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 GS-5745
    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 INNGS-5745
    D.3.9.2Current sponsor codeGS-5745
    D.3.9.3Other descriptive nameGS-5745
    D.3.9.4EV Substance CodeSUB119675
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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
    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
    E.1.1.1Medical condition in easily understood language
    advanced stomach cancer
    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 LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071114
    E.1.2Term Metastatic gastric adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by overall survival (OS)
    E.2.2Secondary objectives of the trial
    To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by progression-free survival (PFS)

    To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

    To compare the safety of GS-5745 versus placebo in combination with mFOLFOX6
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
    1) Male or female ≥ 18 years of age
    2) Histologically confirmed adenocarcinoma of the stomach or GEJ with inoperable, locally advanced or metastatic disease, not amenable to curative therapy
    Adenocarcinoma of the GEJ is defined as tumors that have their center within 5 cm proximal and distal of the anatomical esophago-gastric junction as described in Siewert’s classification system

    3) Eastern Cooperative Oncology Group (ECOG) ≤ 1

    4) Measurable disease or non-measurable but evaluable disease,
    according to RECIST v1.1. Subjects with peritoneal disease would
    generally be regarded as having evaluable disease and allowed to
    enter the trial

    5) Subjects not receiving anticoagulant medication must have an
    international normalized ratio (INR) ≤ 1.5 and activated partial
    thromboplastin (aPTT) ≤ 1.5 x upper limit of normal (ULN).
    The use of full-dose oral or parenteral anticoagulants is permitted
    as long as the INR or aPTT is within therapeutic limits (according
    to the medical standard in the institution) and the subject has been
    on stable dose of anticoagulants for at least 1 week at the time of
    randomization

    6) Adequate hematologic function:

    a) neutrophils more than but equal to 2.0 x 10 power 9/L
    b) platelets more than but equal to 100 x 10 power 9/L
    c) hemoglobin more than but equal to 9 g/dL


    7) Adequate hepatic function:
    a) Direct or total bilirubin less than equal to 1.5 x ULN
    b) ALT and AST less than but equal to 2.5 x ULN, in case of liver metastases
    ≤ 5 x ULN
    8) Creatinine clearance (CLcr) should be ≥ 30 mL/min based on the
    Cockroft-Gault formula. Subjects with a CLcr just below
    30 mL/min may be eligible if a measured creatinine clearance
    (based on 24 hour urine collection or other reliable method) is
    ≥ 30 mL/min
    9) For female subjects of childbearing potential, willingness to use a
    protocol-recommended method of contraception from the
    screening visit throughout the study treatment period, for 90 days
    following the last dose of study drug (GS-5745/placebo), and for 4 months after the last
    dose of oxaliplatin or for
    6 months after the last dose of 5-FU whichever occurs later, unless the subject chooses
    continuous heterosexual abstinence as a lifestyle-choice.

    10) For male subjects of reproductive potential having intercourse with
    females of childbearing potential, willingness to use a protocol
    recommended method of contraception and to refrain from sperm
    donation from the start of study drug, throughout the study
    treatment period, for 90 days after administration of the last dose of
    any study drug, and for 6 months after the last dose of oxaliplatin or 6 months following the last dose of 5-FU whichever occurs later

    11) Breastfeeding females must agree to discontinue nursing before
    study drug administration

    12) In the judgment of the investigator, participation in the protocol
    offers an acceptable benefit-to-risk ratio when considering current
    disease status, medical condition, and the potential benefits and
    risks of alternative treatments for the subject’s cancer

    13) Willingness to comply with scheduled visits, drug administration
    plan, imaging studies, laboratory tests, other study procedures, and
    study restrictions


    14) Evidence of a signed informed consent prior to implementation of
    any protocol specific procedure
    E.4Principal exclusion criteria
    Exclusion Criteria
    Subjects who meet any of the following exclusion criteria are not to be
    randomized in this study:
    1) Previous chemotherapy for locally advanced or metastatic gastric
    or GEJ cancer. Subjects may have received prior neoadjuvant or
    adjuvant chemotherapy as long as it was completed at least
    6 months prior to randomization
    2) Human Epidermal Growth Factor Receptor 2 (HER2) cancer
    (primary tumor or metastatic lesion). HER2-positivity is defined as
    either IHC3+ or IHC2+/ISH+ (ISH positivity is defined as a
    HER2:CEP17 ratio of ≥2.0.)
    3) Patients who have received palliative radiation and have not recovered from all acute, reversible effects
    4) Uncontrolled intercurrent illness including, but not limited to,
    active uncontrolled infection, active gastrointestinal bleeding,
    uncontrolled cardiac arrhythmia, or psychiatric illness/social
    situation that would limit compliance with study requirements as
    judged by treating physician

    5) History of a concurrent or second malignancy except for
    adequately treated local basal cell or squamous cell carcinoma of
    the skin, cervical carcinoma in situ, superficial bladder cancer,
    asymptomatic prostate cancer without known metastatic disease
    and with no requirement for therapy or requiring only hormonal
    therapy and with normal prostate-specific antigen for ≥ 1 year prior
    to randomization, adequately treated Stage 1 or 2 cancer currently
    in complete remission, or any other cancer that has been in
    complete remission for ≥ 5 years

    6) Major surgery, defined as any surgical procedure that involves
    general anesthesia and a significant incision (ie, larger than what is
    required for placement of central venous access, percutaneous
    feeding tube, or biopsy), within 28 days of first dose of study drug

    7) Known positive status for human immunodeficiency virus (HIV)
    8) Known acute or chronic-active infection with hepatitis B virus
    (HBV) or hepatitis C virus (HCV)
    9) Peripheral neuropathy ≥ Grade 2 according to Common
    Terminology Criteria for Adverse Events (CTCAE) v.4.03
    10) Chronic daily treatment with oral corticosteroids
    (dose of > 10 mg/day methylprednisolone equivalent). Inhaled
    steroids and short courses of oral steroids for anti-emesis or as an
    appetite stimulant are allowed
    11) Pregnant or breastfeeding women (pregnancy needs to be excluded
    by testing of beta-human chorionic gonadotropin [β-hCG])
    12) Known or suspected central nervous system metastases
    13) Known dihydropyrimidine dehydrogenase-deficiency
    (special screening not required)
    14) Known alcohol or drug abuse or any other medical or psychiatric
    condition which contraindicates participation in the study
    15) Documented myocardial infarction or unstable/uncontrolled
    cardiac disease (ie, unstable angina, congestive heart failure
    [New York Heart Association > Class II]) within 6 months of
    randomization
    16) Active tuberculosis or history of latent tuberculosis that has not been treated
    17) Any chronic medical condition that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol.
    18) Serious systemic fungal, bacterial, viral, or other infection that is
    not controlled or requires intravenous antibiotics
    19) Experimental medical treatment within 28 days prior to
    randomization
    20) Known hypersensitivity to any of the study drugs or excipients or
    to Chinese hamster ovary cell products or to recombinant human or
    humanized antibodies, or known allergic reactions to products that contain platinum
    21) History of long QT syndrome or whose corrected QT interval (QTc) measured using Fridericia's formula (QTcF = QT/RR0.333) at screening is prolonged (> 450 ms for males and > 470 ms for females)
    22) Subjects with potassium, magnesium or calcium less than the lower limit of normal (LLN); electrolyte replacement is permitted during screening
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) - defined as the time from date of randomization to death from any cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    [Time Frame: Up to 8 years]
    E.5.2Secondary end point(s)
    The following secondary endpoints will be defined and analyzed in this study:
    1) Progression free survival (PFS) – defined as the time from randomization to the earlier of first documentation of definitive disease progression or death from any cause
    2) Objective response rate (ORR) – defined as the proportion of subjects who achieve a CR or PR as assessed by RECIST v1.1
    3) Safety measurements including incidence of adverse events, clinical relevant changes in laboratory values and vital signs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.[Time Frame: Up to 8 years]
    2.[Time Frame: Up to 8 years]
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA99
    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
    Belgium
    Chile
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Peru
    Poland
    Romania
    Spain
    Turkey
    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
    The end of the trial will be defined as when all subjects have completed LTFU (Long Term Follow-Up) or discontinued their participation in the study due to death, withdrawal of consent or lost to follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 172
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 258
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Blind or iliterate subjects can be included with appropriate documentation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 324
    F.4.2.2In the whole clinical trial 430
    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)
    After a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians.
    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 Decision2016-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-15
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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