NCT01066494Unknown2 期
A Phase IIa Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Adult Patients With Acute Myeloid Leukemia (AML)
Antisoma Research6 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- To define the plasma PK Profile of amonafide and metabolite(s)
研究概览
简要总结
A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with 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
- •Willing and able to provide written informed consent
- •In the opinion of the Investigator able to comply with the study assessments and follow-up
- •New diagnosis of AML (i.e. >20 % blasts) as defined by the World Health Organization (WHO) classification (Vardiman 2009) or relapsed or refractory AML as defined by the persistence or recurrence of >5% blasts in bone marrow or peripheral blood following treatment.
- •ECOG Performance status ≤ 2
- •Age > 18 years and ≤ 70 years
- •Adequate hepatic function as evidenced by the following laboratory tests:
- •Total serum bilirubin ≤ 1.5 x ULN or direct (conjugated) bilirubin ≤ 1.5 ULN unless attributable to suspected hepatic involvement with AML
- •Serum AST and ALT ≤ 1.5 x ULN unless attributable to suspected hepatic involvement with AML
- •Adequate renal function as evidenced by serum creatinine ≤ 1.5 x ULN
- •Women of childbearing potential must have a negative serum pregnancy test. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives
- •Left Ventricular Ejection Fraction (LVEF) > 50%, as determined by multiplegated acquisition scan (MUGA) or echocardiogram (ECHO) within 28 days prior to administration of 1st dose of remission induction chemotherapy
排除标准
- •Unwilling to accept the required per protocol blood and urine sample collection
- •An initial diagnosis of acute promyelocytic leukemia as defined by French- American-British criteria (Bennett 1976) (otherwise known as FAB M3)
- •Clinically active CNS leukemia
- •History of clinically significant allergic reactions attributed to compounds of similar chemical or biological composition to amonafide or cytarabine
- •Pregnant or breast feeding
- •Known HIV positive
- •Known active hepatitis B or C, or any other active liver disease
- •Evidence of pulmonary infection. Patients with evidence of pulmonary infection on screening chest x-ray should have chest computed tomography (CT) prior to starting remission induction therapy to confirm absence or presence of pulmonary infection.
- •Any major surgery or radiation therapy within 30 days prior to study entry
- •Previously received treatment with amonafide
- •Treatment with other investigational agents for any reason within 30 days prior to study entry
- •Prior remission induction therapy for AML within 30 days of starting amonafide therapy
- •Persistent non-hematologic toxicity (other than alopecia) greater than Grade 2 from prior therapy for MDS or AML
- •Serious concomitant illnesses (for example, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart
研究组 & 干预措施
Single-arm
Experimental
Amonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7
干预措施: Amonafide + cytarabine (Drug)
结局指标
主要结局
To define the plasma PK Profile of amonafide and metabolite(s)
时间窗: 1 year
To deine the urniary excretion of amonafide and metabolite(s)
时间窗: 1 year
To investigate the fecal excretion of amonafide and metabolite(s) in selected patients
时间窗: 1 year
To evaluate the safety and tolerability of amonafide in combination with cytarabine
时间窗: 1 year
To evaluate the remission rate
时间窗: 1 year
次要结局
- All outcomes are of equal weighting(1 year)
研究者
研究点 (6)
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