A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 22
- 主要终点
- International Working Group (IWG) Response Criteria for MDS
研究概览
简要总结
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Pathological confirmation of Myelodysplastic Syndromes (MDS)
- •Patients must have had no prior systemic therapy
- •Must have normal organ functions
- •Must have the ability to understand and willingness to sign a written informed consent form
排除标准
- •Must not be a result of prior chemotherapy and/or radiotherapy for another malignancy
- •No other agents or therapies administered in the intent to treat
- •Uncontrolled, intercurrent illness
- •Pregnant women and women who are breast feeding
研究组 & 干预措施
Obatoclax Mesylate
Obatoclax Mesylate 30mg
干预措施: Obatoclax mesylate (GX15-070MS) (Drug)
结局指标
主要结局
International Working Group (IWG) Response Criteria for MDS
时间窗: 52 weeks
Determine the response rate according to bone marrow blast count less than or equal to 10%
次要结局
- Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements(52 weeks)