NCT00073541已完成2 期
An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 38
- 试验地点
- 5
研究概览
简要总结
EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.
研究设计
- 研究类型
- Interventional
- 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
- •Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease
- •Immunohistochemical evidence of tumor EGFR (HER-1) expression
- •At least one measurable lesion according to the WHO criteria
- •Life expectancy ≥ 12 weeks
- •ECOG performance status 0-1
排除标准
- •History of prior MAb therapy
- •History of prior treatment with an EGFR (HER-1) directed therapy
- •Known brain metastases
- •Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted)
- •Known intercurrent infections or immunosuppression
- •Actively infected with, or chronic carriers of HBV
- •Evidence of HCV disease
- •Previous diagnosis of autoimmune disease
- •Known hypersensitivity to the administered drugs or any of their components
- •Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment
研究者
研究点 (5)
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