NCT00073489已完成2 期
A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 30
研究概览
简要总结
The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.
详细描述
The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.
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
- •Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood.
- •No previous therapy for CLL.
- •Expected remaining life span greater than or equal to six months.
- •18 years or older.
- •Willingness and ability to sign an informed consent.
排除标准
- •Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
- •History of other malignancy which could affect the diagnosis or assessment of OSI-
- •Previous therapy for CLL.
- •Use of an investigational medication or device within one month of initiating study therapy.
- •Concurrent immunotherapy.
- •Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study).
- •Any condition or any medication which may interfere with the conduct of the study.
- •Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
- •Evidence of CNS involvement.
- •Pregnant or nursing women.
研究者
研究点 (30)
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