Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
GS-5745 With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase III 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
The primary objective of this study is to compare the efficacy of GS-5745 versus placebo in
combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA)
(mFOLFOX6) as measured by overall survival.
Are you eligible?
Adults with histologically confirmed adenocarcinoma of the stomach or
gastroesophageal junction that is inoperable, locally advanced or metastatic and not
amenable to curative therapy
Adequate hematologic, liver, coagulation and kidney function
Eastern Cooperative Oncology Group (ECOG) ≤ 1
Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Previous chemotherapy for locally advanced or metastatic gastric cancer.
Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer
HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Pregnant or breast feeding women
Individuals with known or suspected central nervous system metastases or individuals
requiring chronic daily treatment with oral corticosteroids
Grade ≥ 2 peripheral neuropathy