A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered Every 3 Weeks in Combination With Docetaxel to Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 7
- 主要终点
- RECIST criteria with at least one lesion equal to or greater than 2.0cm using conventional technique or equal to greater than 1.0cm with spiral comupted tomography (CT) scan in a single dimension
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 oncogneic 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 I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation 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 Non-Small Cell Lung Cancer 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 Non-Small Cell Lung Cancer (NSCLC)
- •Must have been previously treated with a single platinum-based chemotherapy regimen and shown evidence of disease progression; no further limitations
- •Must have normal organ function
- •Must be willing to submit to blood sampling for planned PK and PD analysis
- •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 or docetaxel
- •Uncontrolled, intercurrent illness
- •Pregnant women and women who are breast feeding
研究组 & 干预措施
Obatoclax Mesylate + Docetaxel
Obatoclax Mesylate 250mL in combination with Docetaxel
干预措施: Obatoclax mesylate 250 ml (Drug)
Obatoclax Mesylate + Docetaxel
Obatoclax Mesylate 250mL in combination with Docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
RECIST criteria with at least one lesion equal to or greater than 2.0cm using conventional technique or equal to greater than 1.0cm with spiral comupted tomography (CT) scan in a single dimension
时间窗: 18 months
Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
次要结局
- Peripheral blood counts; Bone marrow aspirates and biopsies(18 months)