A Phase I/II, Open-label Multicenter Trial to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 8
- 主要终点
- Safety assessed by frequency, severity and relatedness of adverse events
研究概览
简要总结
This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: GMI-1271 (Drug)
Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: Mitoxantrone (Drug)
Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: Etoposide (Drug)
Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: Cytarabine (Drug)
Arm B (Phase II Arm A)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: GMI-1271 (Drug)
Arm B (Phase II Arm A)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: Mitoxantrone (Drug)
Arm B (Phase II Arm A)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: Etoposide (Drug)
Arm B (Phase II Arm A)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
干预措施: Cytarabine (Drug)
Arm C (Phase II Arm B)
GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older
干预措施: GMI-1271 (Drug)
Arm C (Phase II Arm B)
GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older
干预措施: Cytarabine (Drug)
Arm C (Phase II Arm B)
GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older
干预措施: Idarubicin (Drug)
结局指标
主要结局
Safety assessed by frequency, severity and relatedness of adverse events
时间窗: up to 44 days
次要结局
- Duration of response(up to 12 months)
- Event-free survival(up to 12 months)
- Time versus plasma concentration profile of GMI-1271(up to 11 days)
- Overall response rate(up to 12 months)
- Overall survival(up to 12 months)
- Time to response(up to 12 months)