NCT00081042已完成2 期
An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated with this drug.
- Determine the survival of patients treated with this drug.
- Determine the effects of this drug on biomarkers of melanoma in these patients.
- Correlate biomarker levels with response in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
研究者
研究点 (2)
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