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临床试验/EUCTR2004-001108-11-DE
EUCTR2004-001108-11-DE进行中(未招募)1 期

A phase II study of intravenous TZT-1027, administered weekly times two, every three weeks, to patients with advanced or metastatic soft tissue sarcomas (STS) with prior exposure to doxorubicin-based chemotherapy

European Organisation for the Research and Treatment of Cancer0 个研究点目标入组 28 人开始时间: 2004年9月23日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
28

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

  • ? Histological evidence of high or intermediate grade malignant progressive or metastatic soft tissue sarcoma
  • ? The following tumor types are eligible (WHO classification, 2002, see appendix G)
  • ? Adipocytic (liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type,NOS)
  • ? Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma)
  • ? So-called fibrohistiocytic (pleomorphic MFH”, giant cell MFH”, inflammatory MFH”)
  • ? Leiomyosarcoma (non-organ origin, uterine origin or skin origin)
  • ? Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonal rhabdomyosarcoma
  • ? Vascular (epithelioid haemangioendothelioma, angiosarcoma)
  • ? Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic
  • small round cell, extra-renal rhabdoid, malignant mesenchymoma, PEComa, intimal
  • sarcoma) excluding chondrosarcoma, Ewing tumors / PNET
  • ? Malignant peripheral nerve sheath tumors
  • 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

  • ? The following tumor types are ineligible
  • ? Malignant glomus tumors
  • ? Embryonal rhabdomyosarcoma
  • ? Chondrosarcoma
  • ? Osteosarcoma
  • ? Ewing tumors / PNET
  • ? Gastro-intestinal stromal tumors
  • ? Malignant solitary fibrous tumors
  • ? Dermofibromatosis sarcoma protuberans
  • ? Inflammatory myofibroblastic sarcoma
  • ? Neuroblastoma
  • ? Malignant mesothelioma
  • ? Mixed mesodermal tumors of the uterus
  • ? Other tumors of organ origin, except uterine and skin leiomyosarcoma

研究者

发起方
European Organisation for the Research and Treatment of Cancer

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