NCT00207025终止1 期
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies
Bristol-Myers Squibb3 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.
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
- •Non-hematologic malignancy that has progressed or no standard therapy is known
- •Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •No more than 3 prior chemotherapy regimens in advanced/metastatic setting
- •Absolute neutrophil count >=1,500/mm3 and platelets >=100,000/mm3
- •Bilirubin <=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase <=2.5 x ULN
- •Serum creatinine <=1.5 x ULN
- •Men and women >=18 years
- •Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study
排除标准
- •WOCBP and men not using adequate method of birth control
- •WOCBP who are pregnant or breastfeeding
- •Prior radiation >=25% of bone marrow containing skeleton
- •Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder
- •Neuropathy
- •Active brain metastases
- •Inability to swallow capsules
- •History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube
- •Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy
结局指标
主要结局
Safety and Tolerability
次要结局
- PK, preliminary evidence of antitumor activity
研究者
研究点 (3)
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