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临床试验/EUCTR2013-003324-36-CZ
EUCTR2013-003324-36-CZ进行中(未招募)1 期

Kinetically guided removal of plazma pegylated liposomal doxorubicin to enhance the benefit of cytostatic therapy of patients with ovarian cancer. - The removal of plazma pegylated liposomal doxorubicin for the benefit of therapy.

Charles University in Prague, Faculty of Medicine in Hradec Králové0 个研究点开始时间: 2013年9月11日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

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

  • Criteria for inclusion: 1 / Histologically confirmed epithelial ovarian cancer, fallopian tube or peritoneal carcinoma, 2 / Previous chemotherapy containing platinum and paclitaxel with the rise of resistance to chemotherapy; 3/Progression of disease (clinical findings, imaging techniques - CT, PET-CT MR elevation of tumor marker CA125) 4 / Age 18 years 5 / Performance status = 1, 6 / Life expectancy 12 weeks, 7 / Adequate hematopoietic, hepatic and renal function; 8 / 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 10
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Criteria for exclusion: 1 / Pregnancy and lactation, 2 / Allergy to doxorubicin and other anthracyclines, 3 / Severe cardiac disease (arrhythmia, cardiac insufficiency, status post myocardial infarction), 4 / Prior treatment with anthracyclines up to the maximum cumulative dose (550mg / m2), 5 / significant persistent myelosuppression induced by previous treatment with cytotoxic agents, 6 / Generalized infection 7 / Severe impairment of liver function.

研究者

发起方
Charles University in Prague, Faculty of Medicine in Hradec Králové

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