NCT00632749已完成2 期
An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Efficacy and Pharmacokinetics of BI 811283 in Combination With Cytarabine in Patients With Previously Untreated Acute Myeloid Leukaemia Ineligible for Intensive Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 7
- 主要终点
- The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.
研究概览
简要总结
Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Schedule A
Experimental
BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10
干预措施: BI 811283 (d 1 and 15) (Drug)
Schedule A
Experimental
BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10
干预措施: Cytarabine (Drug)
Schedule B
Experimental
BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10
干预措施: Cytarabine (Drug)
Schedule B
Experimental
BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10
干预措施: BI 811283 (d1) (Drug)
结局指标
主要结局
The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.
时间窗: up to 28 days of treatment
The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only. It was determined using a standard "3 + 3 design with de-escalation".
次要结局
- Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])(Data collected up to cut-off date 20Oct2011, Up to 1239 days)
- Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)(Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days)
- Incidence of Dose Limiting Toxicity (DLT)(up to 28 days of treatment)
- Partial Remission(Data collected up to cut-off date 20 Oct 2011, Up to 1239 days)
- Event Free Survival (EFS)(Data collected up to cut-off date 20 Oct 2011, Up to 1239 days)
- Relapse Free Survival(Data collected up to cut-off date 20 Oct 2011, Up to 1239 days)
- Remission Duration(Data collected up to cut-off date 20 Oct 2011, Up to 1239 days)
- Overall Survival (OS)(Data collected up to cut-off date 20 Oct 2011, Up to 1239 days)
- Cmax (Maximum Measured Concentration of BI 811283 in Plasma)(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)(-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283)
- Cmax (Maximum Measured Concentration of Cytarabine in Plasma)(-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine)
- Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)(-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine)
- AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine)
- AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)(-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine)
- Pharmacodynamic Monitoring(On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only)
- Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone(-0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours)
研究者
研究点 (7)
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