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Clinical Trials/EUCTR2015-001526-42-PL
EUCTR2015-001526-42-PLActive, not recruitingPhase 1

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

Gilead Sciences, Inc.0 sites430 target enrollmentStarted: February 5, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
430
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

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
  • •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

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 [ß-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

Investigators

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