NCT00838890终止1 期
A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2009年3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
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
研究概览
简要总结
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic 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
- •AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher
- •ECOG performance status <= 2
- •Accessible for treatment, PK sample collection and required study follow-up
- •Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN
排除标准
- •Women who are pregnant or breastfeeding
- •Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease)
- •Hyperleukocytosis (defined as peripheral WBC >50,000/uL)
- •Treatment with any other investigational agent for any indication within 30 days of protocol enrollment
- •Subjects a history of gastrointestinal disease
- •Subjects less than four weeks from allogenic or autologous stem cell transplant infusion
研究组 & 干预措施
Cdc7-inhibitor (A)
Active Comparator
干预措施: Cdc7-inhibitor (BMS-863233) (Drug)
Cdc7-inhibitor (B)
Active Comparator
干预措施: Cdc7-inhibitor (BMS-863233) (Drug)
结局指标
主要结局
To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
时间窗: Every 21 or 28 days until maximum tolerated dose is reached
次要结局
- To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer(Every 21 or 28 days until the MTD is reached)
- To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer(Every 21 or 28 days until the MTD is reached)
- To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer(Every 21 or 28 days until the MTD is reached)
研究者
研究点 (4)
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