NCT00309049已完成1 期
An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.
R-Pharm1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •ECOG status of 0-2.
排除标准
- •Unable to swallow pills.
- •Current or recent GI disease or GI surgery.
- •Brain mets.
- •Severe nerve damage.
- •ANC <1,500/mm3
- •Platelets <125K.
- •Bilirubin >=1.5 times the IULN.
- •ALT/AST >=1.5 times the IULN.
- •Creatine >1.5 times the IULN.
- •Prior treatment with Ixabepilone.
- •Strong use of CYPP450 drugs.
研究组 & 干预措施
A1
Active Comparator
干预措施: Ixabepilone (Drug)
A2
Active Comparator
干预措施: Ixabepilone (Drug)
A3
Active Comparator
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
次要结局
- Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Study of Oral Ixabepilone in Subjects With Advanced CancerCancerNCT00422097R-Pharm40
已完成
1 期
Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung CancerNon-small Cell Lung Cancer (NSCLC)NCT00683904R-Pharm12
终止
3 期
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial CancerEndometrial CancerNCT00883116R-Pharm551
已完成
1 期
Phase I Combination Ixabepilone + CisplatinNon Small Cell Lung CancerNCT00832117R-Pharm30
已完成
1 期
Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.Solid MalignanciesNCT00162136R-Pharm35