A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies

Sanofi1 个研究点分布在 1 个国家目标入组 22 人开始时间: 2007年3月1日最近更新: 2011年1月26日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Sanofi
入组人数: 22
试验地点: 1
主要终点: Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed cancer patients without standard of care
•ECOG performance status 0, 1, or 2
•Adequate organ and bone marrow function

排除标准

•Need for a major surgery or radiation therapy during the study
•History of hypersensitivity to S-1
•Known dihydropyrimidine dehydrogenase deficiency
•Uncontrolled hypertension
•History of brain metastases
•Ascites requiring drainage
•Pregnancy or breastfeeding
•Patients who have previously been treated with AVE0005
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

结局指标

主要结局

Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities

时间窗: during the first cycle of study treatment

次要结局

safety: physical examination, laboratory safety tests, adverse events(treatment period)
pharmacokinetic values(treatment period)
objective response rate(treatment period)

研究者

发起方

Sanofi

申办方类型

Industry

研究点 (1)

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