EUCTR2012-005704-17-DK进行中(未招募)1 期
Calcium electroporation for the treatment of cutaneous metastases.
Julie Gehl0 个研究点目标入组 15 人开始时间: 2013年3月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 15
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
- All
入选标准
- •1. Age > 18 years
- •2. Patients should understand participants information.
- •3. Histologically confirmed cutaneous metastases of any histology.
- •4. At least 1. cutaneous metastases, between 0,5 to 3 cm, available to electroporation.
- •5. Patient should have been offered standard treatment.
- •6. At least 2 weeks since chemotherapy or radiotherapy.
- •7. performance status < 2 (ECOG)
- •8. Life expectancy >3 months
- •9. platelet count >50 mia/l, INR<1,2
- •10. Men and women of reproductive age must use effective contraception during the study.
- •11. Signed informed consent.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. previously treatment with bleomycin > 200.000 Units/m2
- •2. Allergy to bleomycin.
- •3. Clinically significant coagulopathy.
- •4. Pregnancy or lactation.
- •5. Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
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