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临床试验/TCTR20190701001
TCTR20190701001招募中2 期

Phase II, Multi-Center, Open-Label, Single-Arm Study Evaluating the Efficacy and Safety of Mycophenolate Mofetil in Patients with High-Grade Locally Advanced or Metastatic Osteosarcoma (ESMMO)

Faculty of Medicine, Chiang Mai University0 个研究点目标入组 27 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
27

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
13 Years 至 N/A (No limit)(—)
性别
All

入选标准

  • 1. High-grade locally advanced or metastatic osteosarcoma;
  • 2. Measurable disease;
  • 3. Evidence of disease progression after treatment with standard chemotherapy regimen or evidence of patient refusal for any further treatment with standard chemotherapy regimens;
  • 4. ECOG performance status of <=2;
  • 5. Age >=13 years;
  • 6. Adequate organ function; and
  • 7. Evidence of a personally signed and dated informed consent (or assent, when applicable) document.

排除标准

  • 1. History of another malignancy within 5 years;
  • 2. Current treatment with another investigational agent and/or systemic anticancer therapy;
  • 3. Surgery and/or radiotherapy for curative intent;
  • 4. History of allergic reactions attributed to mycophenolate mofetil, mycophenolic acid, or any ingredients of the drugs;
  • 5. History of severe or uncontrolled medical conditions or laboratory abnormality;
  • 6. Impaired renal function;
  • 7. Known or suspected pregnancy or breastfeeding;
  • 8. Any other conditions in which mycophenolate mofetil is contradicted;
  • 9. Unable to swallow oral medications;
  • 10. Major surgery; or
  • 11. Significantly altered mental status.

研究者

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