An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With Neutropenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0
研究概览
简要总结
An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia with neutropenia.
A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing.
All patients will receive chemotherapy for their AML according to local clinical standard of care as well as antifungal prophylaxis.
APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written consent
- •Ages 18-75 inclusive, male or female
- •Diagnosis of Acute Myeloid Leukemia
- •Patients entering first induction treatment chemotherapy
- •Expected to be neutropenic (<500 ANC/ul) for >/= 10 days
排除标准
- •Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months
- •Current fever (> 38 degrees Celsius)
- •Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine
研究组 & 干预措施
APX001 with Standard of Care Anti-fungal agent
干预措施: APX001 with Standard of Care anti-fungal agent (Drug)
结局指标
主要结局
Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0
时间窗: One to forty-four days
次要结局
- Area under the plasma concentration versus time curve (AUC)(One to forty-four days)
- Peak Plasma Concentration (Cmax)(One to forty-four days)