A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of AG-024322, An Inhibitor Of Cyclin-Dependent Kinase 1, 2 And 4, Administered Intravenously Daily For 5 Days Every 3 Weeks To Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- To test the safety of AG-024322 when taken by people who have cancer
研究概览
简要总结
AG-024322 may work in cancer by stopping cancer cells from multiplying. AG-024322 is and intravenous drug from a new class of drugs call cyclin-dependent kinase (CDK inhibitors). This research study is the first time that AG-024322 will be given to people.
详细描述
The study was prematurely discontinued due to the inability of the compound to adequately differentiate from other treatment options in the clinical endpoint and necessary product profile on April 13, 2007. Safety profile was not the reason that led to the discontinuation of the program.
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
- •Advanced solid tumors or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition
- •Adequate blood cell counts, kidney function and liver function and and ECOG score of 0 or 1.
排除标准
- •Prior high-dose chemotherapy requiring hemapoietic stem cell rescue
- •Previous radiation therapy to >25% of the bone marrow
- •Active or unstable cardiac disease or history of heart attack within 6 months
研究组 & 干预措施
1
干预措施: AG-024322 (Drug)
结局指标
主要结局
To test the safety of AG-024322 when taken by people who have cancer
To find the AG-024322 dose that should be used in future clinical trials that will study effectiveness
To assess how the human body handles blood concentrations of AG-024322
次要结局
未报告次要终点