A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies

Regeneron Pharmaceuticals0 个研究点目标入组 48 人开始时间: 2012年10月最近更新: 2015年3月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Regeneron Pharmaceuticals
入组人数: 48
主要终点: Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)

研究设计

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

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Inclusion criteria include, but are not limited to, the following:
•Confirmed diagnosis of solid tumor malignancy
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Adequate hepatic, renal and bone marrow function
•Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1

排除标准

•Exclusion criteria include, but are not limited to, the following:
•Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
•Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
•Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
•Patients with deep vein thrombosis or pulmonary embolism within last 3 months
•Patients with serious non healing wound or acute ulcer
•Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months
•Patients with history of abdominal or tracheal-esophageal fistula
•Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
•Prior treatment with bevacizumab within last 6 weeks
•Pregnant or breast-feeding women