A Phase I Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax (Maximum Plasma Concentration)
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Each patient had to meet the following criteria to be eligible for the study:
- •Patients with MDS (de novo or secondary) must have been 60 years or older and have had disease fitting any of the recognized French-American-British classifications OR chronic myelomonocytic leukemia (with white blood cell [WBC] <12,000/μL) AND have had an International Prognostic Scoring System score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry.
- •Patients with AML (≥30% bone marrow blasts) must have been age 18 years or older and had previously received standard induction chemotherapy and/or had failed approved therapies.
- •Must have had Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Must have signed an Institutional Review Board (IRB)-approved informed consent form, indicating his/her awareness of the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
- •Must have had adequate renal and hepatic function (creatinine ≤2.0 mg/dL, total bilirubin <2.0 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 X institutional upper limit of normal).
- •Must have had life expectancy of at least 12 weeks.
- •Must have recovered from all toxic effects of all prior therapy before entry into this study.
排除标准
- •Patients with MDS must not have been candidates for high-dose chemotherapy, bone marrow or stem cell transplant.
- •Must not have had acute promyelocytic leukemia (M3 classification).
- •Must not have received immunosuppressive therapy for 30 days prior to study entry.
- •Must not have had central nervous system (CNS) leukemia.
- •Must not have received systemic corticosteroids, interferon, interleukins or other hormonal therapy within 30 days prior to study entry. Use of corticosteroids (topical and inhaled corticosteroids) was permitted and prophylactic steroids may have been used to treat or prevent transfusion reactions.
研究组 & 干预措施
1
干预措施: Decitabine (Dacogen) (Drug)
结局指标
主要结局
Cmax (Maximum Plasma Concentration)
时间窗: Day 1, Day 2, Day 3
3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
Average Total Body Clearance (Calculated From Rate and Concentration)
时间窗: Day 1, Day 2, Day 3
3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
Tmax (Time at Which Cmax First Observed)
时间窗: Day 1, Day 2, Day 3
3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
时间窗: Day 1, Day 2, day 3
3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
次要结局
- Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)(6 weeks)