NCT00879554已完成1 期
A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors
研究概览
简要总结
The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.
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
- •Confirmed advanced solid tumors unresponsive to currently available therapies, or for which there is no standard therapy.
- •Adequate coagulation, liver and renal function.
- •Candidate for DCE-MRI evaluation.
- •ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
排除标准
- •Evidence of bleeding problems.
- •Uncontrolled hypertension.
- •Certain gastrointestinal problems including fistula and abscess.
- •Patients with primary brain cancer.
结局指标
主要结局
To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors
时间窗: Throughout duration of study
To identify and characterize CVX-045-related adverse events (AEs)
时间窗: Throughout duration of study
次要结局
- To document any preliminary evidence of antitumor activity(Every 8 weeks)
- To evaluate the plasma pharmacokinetics (PK) of CVX-045(Days 1, 4, 8, 15, 29)
- To determine a recommended Phase 2 dose of CVX-045(End of study)
- To evaluate the potential for immunogenicity of CVX-045(Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU)
研究者
研究点 (4)
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