None listed
Conditions
Interventions
Subjects will be administered 800 mg GS-5745/placebo intravenous over approximately 30 minutes and in advance of mFOLFOX6 on Days 1 and 15 of each cycle. The dosing regimen for each subject will adher
Sponsors
Gilead Sciences, Inc.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1)Male or female more or equal than 18 years of age 2)Histologically confirmed adenocarcinoma of the stomach or GEJ with inoperable, locally advanced or metastatic disease, 3)Eastern Cooperative Oncology Group (ECOG) ≤ 1 4)Measurable disease or non-measurable but evaluable disease, according to RECIST v1.1. 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 6)Adequate hematologic function 7)Adequate hepatic function 8)Creatinine clearance (CLcr) should be ≥ 60 mL/min based on the Cockroft-Gault formula 9)For subjects of childbearing potential, willingness to use a protocol recommended method of contraception 14)Evidence of a signed informed consent
Exclusion criteria
Exclusion criteria: 1)Previous chemotherapy for locally advanced or metastatic gastric or GEJ cancer. 2)Human Epidermal Growth Factor Receptor 2 (HER2) cancer 3)Radiotherapy within 28 days of randomization 5)History of a concurrent or second malignancy 6) Major surgery,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 10)Chronic daily treatment with oral corticosteroids 13)Known dihydropyrimidine dehydrogenase-deficiency 15)Documented myocardial infarction or unstable/uncontrolled cardiac disease 16)Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
Countries
Australia, Belgium, Colombia, Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Spain, Turkey, United Kindgdom, United States
Contacts
Public ContactElizabeth Ayala
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed