A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Phase I: To evaluate the safety and tolerability of several dose levels of CPG 7909 (up to a maximum of 0.16 mg/kg) and to determine the maximum tolerated dose (MTD)* of CPG 7909 in combination with Herceptin®
研究概览
简要总结
To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.
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
- •Histologically confirmed breast cancer with metastases
- •Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry
- •Patients may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy.
- •Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques, or as > 10 mm with spiral CT scan
排除标准
- •Any prior therapy with anthracycline + Herceptin® concurrently
- •Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction < 50%
- •Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia
研究组 & 干预措施
Cohort 1
0.04 mg/kg CpG 7909
干预措施: 0.04 mg/kg CpG 7909 (Drug)
Cohort 1
0.04 mg/kg CpG 7909
干预措施: Herceptin® (Drug)
Cohort 2
0.08 mg/kg CpG 7909
干预措施: 0.08 mg/kg CpG 7909 (Drug)
Cohort 2
0.08 mg/kg CpG 7909
干预措施: Herceptin® (Drug)
Cohort 3
0.12 mg/kg CpG 7909 Injection once weekly
干预措施: 0.12 mg/kg CpG 7909 (Drug)
Cohort 3
0.12 mg/kg CpG 7909 Injection once weekly
干预措施: Herceptin® (Drug)
Cohort 4
0.16 mg/kg CpG 7909
干预措施: 0.16 mg/kg CpG 7909 (Drug)
Cohort 4
0.16 mg/kg CpG 7909
干预措施: Herceptin® (Drug)
结局指标
主要结局
Phase I: To evaluate the safety and tolerability of several dose levels of CPG 7909 (up to a maximum of 0.16 mg/kg) and to determine the maximum tolerated dose (MTD)* of CPG 7909 in combination with Herceptin®
时间窗: 24 weeks
Phase II: To evaluate tumor response and safety of CPG 7909 (at the MTD as determined in Phase I) in combination with Herceptin® in patients with metastatic breast cancer.
时间窗: 24 weeks
次要结局
- Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.(24 weeks)
- Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.(24 weeks)