EUCTR2006-003580-31-NL进行中（未招募）不适用
A Study of the Efficacy of MORAb-003 in Subjects with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Morphotek
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •age over 18 years
- •diagnosis of epithelial platin-sensitive ovarian cancer in first relapse after a remission of 6 - 18 months
- •surgery to remove tumor before first remission
- •CA 125 elevation before first tratment
- •CA 125 elevation at the time of relapse
- •life expectancy over 6 months
- •ECOG performance status 0-2
- •eligible for retreatment with the same chemotherapy regimen that was used to induce remission
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •known central nervous system tumor involvement
- •evidence of other active malignancy requiring treatment
- •Clinically significant heart disease
- •ECG demonstrating clinically significant arrythmias
- •active serious systemic disease
- •active hepatitis or HIV infection
- •Treatment within three months with immunomodulatory therapy
- •breast-feeding, pregnancy or likely to become pregnant during study
- •participation in parallel studies
研究者
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