NCT00271063Unknown1 期
Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- To evaluate the safety and tolerability of L-Annamycin
研究概览
简要总结
This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.
详细描述
This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal annamycin are planned: 190, 230, 280, and 310 mg/m2/day.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)
- •Age greater than or equal to 15 years
- •No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
- •No investigational therapy within 4 weeks of first dose of study drug
- •ECOG performance status (PS) 0 to
- •Adequate liver function
- •Adequate renal function
- •Signed informed consent
排除标准
- •Concommitant therapy that includes other chemotherapy that is or may be active against ALL (except central nervous system [CNS] therapy)
- •Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- •Cardiac ejection fraction less than 40%
- •Clinically relevant serious co-morbid medical conditions.
- •Pregnant, lactating or not using adequate contraception.
- •Known allergy to doxorubicin or anthracyclines.
结局指标
主要结局
To evaluate the safety and tolerability of L-Annamycin
时间窗: 8 months
MTD
时间窗: 8 months
次要结局
- To study multi drug-resistant (MDR)-1 encoded P-170 glycoprotein expression and MDR-1 multidrug-resistant-associated protein (MRP), lung-resistance associated protein LRP), and breast cancer resistance protein (BCRP) mRNA levels(8 months)
- To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.(8 months)
研究者
研究点 (6)
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