NCT00093119已完成2 期
A Phase II Trial of ABI-007 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
- 发起方
- Celgene
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
研究概览
简要总结
This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 Metastatic Melanoma
- •At least 18 years old
- •No other active malignancy
- •Hemoglobin at least 9
- •Platelet Count at least 100,000 cells/mm3
- •ANC at least 1500 cells/mm3
- •AST & ALT less than 2.5X upper limit of normal
- •Total bilirubin less than 1.5mg/dL
- •Creatine less than 1.5 mg/dL
- •Alkaline phosphatase less than 2.5X upper limit of normal
- •Life expectancy of at least 12 weeks
- •ECOG performance status of 0-1
- •Patient must provide informed consent
- •Patient must provide authorization to disclose
排除标准
- •Evidence of active brain metastases
- •The only evidence of metastasis is lytic or blastic bone metastases
- •Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
- •Received radiotherapy in last 4wks, except if to a non-target lesion only
- •Clinically significant concurrent illness
- •Investigator's opinion that patient unlikely to complete study
- •Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks
- •History of allergy/hypersensitivity to study drug
- •Serious Medical Risk Factors determine by the investigator
结局指标
主要结局
Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
次要结局
- Evaluate number of cycles required before patients achieve maximum response
研究者
研究点 (2)
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