A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Phase I: To evaluate the safety, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer
研究概览
简要总结
The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.
RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.
SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.
详细描述
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
0.01 mg/kg CPG 7909 plus Herceptin®
干预措施: CPG 7909 (Drug)
Cohort 1
0.01 mg/kg CPG 7909 plus Herceptin®
干预措施: Herceptin® (Drug)
Cohort 2
0.04 mg/kg CPG 7909 plus Herceptin®
干预措施: CPG 7909 (Drug)
Cohort 2
0.04 mg/kg CPG 7909 plus Herceptin®
干预措施: Herceptin® (Drug)
Cohort 3
0.16 mg/kg CPG 7909 plus Herceptin®
干预措施: CPG 7909 (Drug)
Cohort 3
0.16 mg/kg CPG 7909 plus Herceptin®
干预措施: Herceptin® (Drug)
Cohort 4
0.32 mg/kg CPG 7909 plus Herceptin®
干预措施: CPG 7909 (Drug)
Cohort 4
0.32 mg/kg CPG 7909 plus Herceptin®
干预措施: Herceptin® (Drug)
结局指标
主要结局
Phase I: To evaluate the safety, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer
Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer
次要结局
- Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time
- Phase II: To evaluate duration of response, time to disease progression, and survival time