Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

GS-5745 With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Protocol: OSU-15197

Full Title

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

Purpose

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?

Inclusion Criteria:

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

Exclusion Criteria:

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

Stomach (Gastric) Cancer Gastrointestinal Cancers