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临床试验/EUCTR2006-000366-36-BE
EUCTR2006-000366-36-BE进行中(未招募)不适用

Phase 3 randomized study of TLK286 (Telcyta™) in combination with liposomal doxorubicin (Doxil®/Caelyx®) versus liposomal doxorubicin (Doxil®/Caelyx®) as second-line therapy in platinum refractory or resistant ovarian cancer - ASSIST-5

Telik, Inc.0 个研究点目标入组 244 人开始时间: 2006年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Telik, Inc.
入组人数
244

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

  • 1. Considered platinum refractory or resistant according to standard criteria.
  • 2. Histologically or cytologically confirmed epithelial cancer of the ovary, fallopian tube or primary peritoneal cancer.
  • 3. Measurable disease including at least one measurable lesion according to RECIST criteria with documented tumor progression before study entry or disease that has not responded to treatment.
  • 4. Female = 18 years of age.
  • 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

  • 1. Treatment with chemotherapy other than a platinum-based regimen.
  • 2. Treatment with more than two platinum-based regimens.
  • 3. Clinically significant cardiac disease.
  • 4. Any signs of intestinal obstruction interfering with nutrition.
  • 5. Pregnant or lactating women.
  • 6. History of prior liposomal doxorubicin or anthracycline chemotherapy for ovarian cancer.
  • 7. History of prior TLK286 (Telcyta™) therapy.

研究者

发起方
Telik, Inc.

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