PER-011-16已完成未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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
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