跳至主要内容
临床试验/EUCTR2020-002579-37-IT
EUCTR2020-002579-37-IT进行中(未招募)1 期

Metformin as maintenance therapy in bone sarcomas at high risk of relapse - Metformin-Bone

ISTITUTO ORTOPEDICO RIZZOLI0 个研究点目标入组 60 人开始时间: 2020年10月22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)
入组人数
60

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

  • - Age = 14 years
  • - Patients with localized osteosarcoma with necrosis = 60% at the end of postoperative chemotherapy (within 45 days)
  • - Patients with osteosarcoma or Ewing's Sarcoma made disease-free after the first relapse (within 45 days of surgery or chemotherapy)
  • - Patients not included in other protocols
  • - Patients who can swallow
  • - Screening within 30 days after the end of chemotherapy (or relapse surgery).
  • - Start of treatment within 30 minutes after screening
  • - Normal renal function (creatinine <1.3, creatinine > 60) and liver function (serum bilirubin <1.4, AST and ALT <1.8) above the normal range.
  • Are the trial subjects under 18? yes
  • 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 60
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Type I or II diabetes
  • - Patient with metastatic disease
  • - Patients with kidney failure of any degree
  • - Patient who does not meet the inclusion criteria

研究者

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