A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 7
- 主要终点
- Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
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 oncogenic 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.
详细描述
This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.
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
- •Histologically confirmed myelofibrosis with myeloid metaplasia.
- •No limitations on allowable type and amount of prior therapy.
- •Patients must have normal organ function.
- •Must be willing to submit to blood sampling for planned PK and PD analyzes.
- •Must have ability to understand and willingness to sign a written informed consent form.
排除标准
- •No other agents or therapies administered with the intent to treat malignancy.
- •Patients with prior exposure to obatoclax.
- •Uncontrolled, intercurrent illness.
- •Pregnant women and women who are breast feeding.
研究组 & 干预措施
GX15-070MS
Obatoclax mesylate 60mg
干预措施: Obatoclax mesylate (GX15-070MS) (Drug)
结局指标
主要结局
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
时间窗: 1 Year
次要结局
- Peripheral blood counts(4 Weeks to 1 Year)
- Bone marrow aspirates and biopsies(8 weeks to 1 year)
- Transfusion and growth factor requirements(8 weeks to 1 year)