NCT01193491终止1 期
A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety and Tolerability of IPI-493 in Patients Experiencing Advanced Hematologic Malignancies With Client Proteins of Hsp90
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Evaluation of Safety Endpoints
研究概览
简要总结
The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and schedule of IPI-493 in patients with hematologic malignancies.
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
- •>/=18 years old
- •confirmed hematological malignancy
- •refractory to available therapy or for which no therapy is available
- •adequate hepatic, renal function
排除标准
- •active CNS malignancy
- •prolonged QT interval
- •significant GI/liver disease
- •other serious concurrent illness or medical condition
研究组 & 干预措施
IPI-493
Experimental
干预措施: IPI-493 (Drug)
结局指标
主要结局
Evaluation of Safety Endpoints
时间窗: 1 year
Safety Endpoints * The incidence of reported adverse events (AEs), serious adverse events (SAEs), concomitant medication use, laboratory test results, electrocardiogram (ECG) results, Eastern Cooperative Oncology Group (ECOG) performance status results, and vital sign results * Maximum tolerated dose, defined as the dose level below the dose at which ≥33% of patients experience a dose limiting toxicity (DLT) Pharmacodynamic Endpoints
次要结局
- Evaluation of Efficacy Endpoints(1 year)
研究者
研究点 (3)
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