A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 19
- 主要终点
- Collect long term ALN-VSP02 safety data
研究概览
简要总结
This study provides a mechanism for continued administration of ALN-VSP02 therapy to patients with cancer who completed participation in another ALN-VSP02 clinical study. The primary objective of this study is to collect long term safety data.
详细描述
Study ALN-VSP02 is an extension study for previously conducted ALN-VSP02 studies. The study is being conducted to allow for continued ALN-VSP02 therapy for patients who completed participation in an ALN-VSP02 clinical study, achieved clinical benefit with ALN-VSP02 (i.e., disease response of stable disease or better), and, in the Investigator's opinion, may benefit from continuation of ALN-VSP02 therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient has completed a previous ALN-VSP02 study, and is deemed to have stable disease or better.
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Patient has adequate hematologic, liver, and renal function.
排除标准
- •Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin > 325 mg/day or other platelet inhibitory agents.
- •Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrhythmia.
- •Patient has clinically significant cerebrovascular disease.
- •Patient has a seizure disorder not controlled on medication.
结局指标
主要结局
Collect long term ALN-VSP02 safety data
时间窗: Throughout the study
Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.
次要结局
- Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)(Every 2 months)
- Evaluate preliminary evidence of antitumor activity/antiangiogenic activity(Every 3 - 6 months)