Phase 1 Study of IACS-010759 in Subjects With Relapsed or Refractory AML
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) Defined as the Highest Dose Studied for Which the Observed Incidence of Dose Limiting Toxicities (DLT) is Less Than 33%
研究概览
简要总结
This phase I trial studies the side effects and best dose of oxidative phosphorylation inhibitor IACS-010759 in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Oxidative phosphorylation inhibitor IACS-010759 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
详细描述
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined the study. Up to 6 groups of 3-6 participants will be enrolled in the dose escalation part of the study. Up to 18 participants will be enrolled in dose expansion.
OUTLINE: This is a dose-escalation study.
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 orally (PO) once daily (QD) on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
After completion of study treatment, patients are followed up every 3-6 months for up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
Treatment (oxidative phosphorylation inhibitor IACS-010759) Cohort 1
IACS-010759 Starting dose: 0.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
干预措施: Oxidative Phosphorylation Inhibitor IACS-010759 (Drug)
Treatment (oxidative phosphorylation inhibitor IACS-010759) Cohort 2
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
干预措施: Oxidative Phosphorylation Inhibitor IACS-010759 (Drug)
Treatment (oxidative phosphorylation inhibitor IACS-010759) Cohort 3
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
干预措施: Oxidative Phosphorylation Inhibitor IACS-010759 (Drug)
Treatment (oxidative phosphorylation inhibitor IACS-010759) Cohort 3
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
干预措施: Pharmacological Study (Other)
Treatment (oxidative phosphorylation inhibitor IACS-010759) Cohort 4
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
干预措施: Oxidative Phosphorylation Inhibitor IACS-010759 (Drug)
Treatment (oxidative phosphorylation inhibitor IACS-010759) Cohort 4
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Maximum Tolerated Dose (MTD) Defined as the Highest Dose Studied for Which the Observed Incidence of Dose Limiting Toxicities (DLT) is Less Than 33%
时间窗: Up to 28 days
Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.03.
次要结局
- Progression-free Survival(Up to 5 years)
- Overall Survival(Up to 5 years)
- Participants With a Response(Up to 5 years)
- Duration of Response(Up to 5 years)