An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 211
- 试验地点
- 38
- 主要终点
- To determine complete response (CR) rate
研究概览
简要总结
This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.
详细描述
This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML. The study will primarily assess the complete response (CR) rate of a 5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy in adult patients with AML, with secondary objectives to determine the overall, relapse-free and event-free survival and remission duration; to determine the duration of response; to determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine; and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic activity and adverse events. Additional cycles of treatment may be given at the investigator's discretion, provided that the subject does not have progressive disease or experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will be allowed.
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
- •Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
- •Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
- •Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.
- •Subjects must have adequate organ and immune function as indicated by the following laboratory values:
- •Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;
- •Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);
- •AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of < 2, and an estimated life expectancy of at least eight weeks.
排除标准
- •Clinical evidence of active central nervous system (CNS) leukemic involvement
- •Active and uncontrolled infection
- •Uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment
- •Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
- •Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
- •A recent history of alcohol or other substance abuse
- •Subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
- •Females with a positive pregnancy test at screening
- •Subjects who have previously been enrolled into this study and subsequently withdrew
结局指标
主要结局
To determine complete response (CR) rate
次要结局
- To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates
- Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters