NCT00324129已完成1 期
A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose In Patients With Leukemia Or Myelodysplastic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 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 weekly to patients with leukemia or myelodysplastic syndromes.
详细描述
Phase I dose escalating study.
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
- •Patients must have a diagnosis of one of the following:
- •relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy
- •relapsed or refractory Myelodysplastic Syndromes
- •previously untreated AML or Myelodysplastic Syndromes in patients > 60 years of age who refused or are not candidates for induction chemotherapy
- •Patients with relapsed or refractory CML that has failed to respond to Imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists
- •ECOG performance status of 0, 1, or 2
- •Age ≥ 18 years
- •Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry
排除标准
- •Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia
- •Pregnant or lactating women
- •Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the study and for 90 days following the last dose of study medication
- •Patients with known meningeal metastasis(es)
- •Patients with active or uncontrolled infections, or with a fever >38.5 C
- •Patients with serious illnesses, medical conditions, or other medical history, which would be likely to interfere with a patient's participation in the study
- •Patients who have been treated with any investigational drug or anti-cancer therapy within 30 days of study start.
研究组 & 干预措施
1
Experimental
干预措施: MGCD0103 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 1 year (anticipated)
Pharmacokinetics
时间窗: 1 year (anticipated)
次要结局
- Dose limiting toxicities(1 year (anticipated))
- Pharmacodynamics (histone acetylation, biomarkers)(1 year (anticipated))
- Clinical Response(1 year (anticipated))
研究者
研究点 (3)
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