A Phase 1 Dose-Escalation Study of AEB1102 (Co-ArgI-PEG) in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Refractory to Hypomethylating Agents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 14
- 主要终点
- Maximum Tolerated Dose and Recommended Phase 2 Dose
研究概览
简要总结
This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.
详细描述
First study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Willing and able to provide informed consent
- •Age 18 and older
- •Diagnosis of AML or MDS according to the WHO criteria
- •AML relapsed or refractory to at least one attempt at induction or subjects not candidates for aggressive induction regimens
- •MDS refractory to treatment with HMA therapy or with recurrence or progression of MDS following a response to an HMA
- •Has adequate organ function: AST and ALT < 3X the ULN, serum bilirubin < 2X the ULN, serum creatinine of < 2 mg/dL, or a calculated creatinine clearance of > 50 mL/minute
- •ECOG Performance Score of 0 -2
- •Recovered from the effects of any prior systemic therapy, radiotherapy or surgery
- •Willing to use physician approved birth control method
排除标准
- •Current CNS Leukemia
- •Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality or Bcr/Abl positive leukemia
- •< 60 days from ASCT; has chronic graft-versus host disease (GVHD) or requires continued treatment with systemic immunosuppressive agents
- •Uncontrolled infection
- •Known HIV, hepatitis B or hepatitis C.
- •Other active malignancy that requires therapy
- •If female, is lactating or breast feeding
- •Hypersensitivity to PEG or other component of AEB1102 (Co-ArgI-PEG)
研究组 & 干预措施
AEB1102 (Co-ArgI-PEG) administered via IV weekly.
Co-ArgI-PEG modified human arginase I
干预措施: Co-ArgI-PEG modified human arginase I (Drug)
结局指标
主要结局
Maximum Tolerated Dose and Recommended Phase 2 Dose
时间窗: 4 weeks
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
次要结局
- Safety profile (changes in physical exam, laboratory measures, reported adverse events)(4 Weeks)