NCT00067314已完成2 期
A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 65
- 试验地点
- 20
- 主要终点
- To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
研究概览
简要总结
This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.
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
- •Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
- •Must have received any chemotherapy regimen in the past
- •Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
- •Must have measurable (by imaging techniques) disease
- •Adequate bone marrow, liver and renal function
- •Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
排除标准
- •Received more than 2 prior chemotherapy regimens for metastatic disease
- •Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
- •Enrolled in another clinical intervention study
- •Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
- •Cardiac or thrombotic event in the last 12 months
- •Brain metastases
结局指标
主要结局
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
次要结局
- Time to tumor progression (TTP)
- Clinical benefit
- Time to tumor response (TAR)
- performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
- [Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
- Time to treatment failure (TTF)
- ie, a composite profile of pain intensity
- analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
- Duration of response (DR)
- Overall survival (OS)
- Plasma pharmacokinetic parameters
- Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]
研究者
研究点 (20)
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