NCT00161642已完成1 期
A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.
Wyeth is now a wholly owned subsidiary of Pfizer3 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Physical examinations
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected.
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
- •Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available
- •Tumor expression of Lewis Y antigen ( > or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
- •Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to the first dose of CMD-
- •Significant prior allergic reaction to recombinant human or murine proteins
结局指标
主要结局
Physical examinations
hematology panels
ECG
次要结局
- Radiographic tumor evaluations
- blood sampling for pharmacokinetic assessments
研究者
研究点 (3)
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