A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
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 I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. 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 patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 Mantle Cell Lymphoma (ML)
- •Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
- •Must have normal organ function
- •Must have the 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
1
30mg obatoclax, 1.0mg/m2 bortezomib
干预措施: Obatoclax mesylate (Drug)
1
30mg obatoclax, 1.0mg/m2 bortezomib
干预措施: Bortezomib (Drug)
2
obatoclax 30 mg, bortezomib 1.3 mg/m2
干预措施: Obatoclax mesylate (Drug)
2
obatoclax 30 mg, bortezomib 1.3 mg/m2
干预措施: Bortezomib (Drug)
3
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
干预措施: Obatoclax mesylate (Drug)
3
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
干预措施: Bortezomib (Drug)
结局指标
主要结局
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
时间窗: 4 weeks to 2 years
次要结局
- Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements(4 weeks to 2 years)