NCT00374296终止2 期
A Phase II Study of MGCD0103 (MG-0103) in Patients With Acute Myelogenous Leukemia/High Risk MDS Who Are Elderly and Have Previously Untreated Disease or Who Are Adult and Have Relapsed/Refractory Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 13
- 主要终点
- Safety and tolerability
研究概览
简要总结
In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease.
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
- •Pathologic confirmation of AML or high risk MDS.
- •Elderly cohort (70 years of age or more): no prior chemotherapy treatment for AML/high risk MDS and not currently candidates for intensive chemotherapy.
- •Relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
- •ECOG performance status of 0 or
- •Total bilirubin < 1.5 x upper limit of normal (ULN).
- •AST/SGOT and ALT/SGPT < 2.5 x ULN.
- •Serum creatinine < 1.5 x ULN.
- •Patients must read, understand, and sign a written informed consent form (ICF).
- •Women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment.
排除标准
- •Pregnant or lactating women.
- •Patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever > 38.5C (not due to tumor fever) on the day of scheduled dosing.
- •Patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
- •Patients treated with an investigational drug within 30 days prior to study initiation.
- •Known hypersensitivity to HDAC inhibitors or to any of the components of MG-
- •Known HIV or active hepatitis B or C.
- •Any condition that may affect the patient's ability to sign the ICF and undergo study procedures.
- •Any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
研究组 & 干预措施
2
Experimental
Relapsed/Refractory Arm
干预措施: MGCD0103 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 1 year (anticipated
Response rate
时间窗: 1 year (anticipated)
次要结局
- Progression-free survival(1 year (anticipated))
- Duration of objective response(1 year (anticipated))
- Pharmacokinetics(1 year (anticipated))
- Pharmacodynamics(1 year (anticipated))
研究者
研究点 (13)
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