EUCTR2005-004272-20-FR进行中（未招募）1 期
Phase II Study of E7389 Administered as an IV Infusion Day 1 and 8 every 3 Weeks in Pretreated Patients with Advanced and/or Metastatic Soft Tissue Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •- Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade, and of one of the following histologies: leiomyosarcoma, adipocytic, synovial sarcoma and other type of sarcoma.
- •- Presence of measurable disease (as defined by RECIST)
- •- Evidence of objective progression within the last 6 months (RECIST)
- •- Patients must have received no more than one combination or two single agent chemotherapy regimens for advanced disease; (neo)adjuvant therapy is not counted towards this requirement
- •- WHO performance status 0 or 1
- •- Adequate bone marrow, hepatic, renal and cardiac functions
- •- Written informed consent must be given
- •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
- •- Prior history of malignancies other than sarcoma
- •- Significant cardiovascular impairment
- •- Parients who are receiving anti-coagulant therapy with warfarin or related compounds
- •- Severe/uncontrolled intercurrent illness/infection
- •- Hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
- •- Patients who participated in a prior E7389 clinical trial
- •- Any condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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