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临床试验/NCT03994627
NCT03994627Approved For Marketing不适用

An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma

Eli Lilly and Company87 个研究点 分布在 1 个国家开始时间: 2019年6月21日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
Approved For Marketing
试验地点
87

研究概览

简要总结

The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).

研究设计

研究类型
Expanded Access

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are currently receiving olaratumab and who, in consultation with their treating physician, want to continue their course of therapy.
  • Have metastatic or locally advanced unresectable soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.
  • Have given written informed consent.
  • Have an absolute neutrophil count (ANC) ≥1,000/microliter.
  • Females of childbearing potential and males must agree to use highly effective contraceptive precautions during treatment with olaratumab and up to 3 months following the last dose of olaratumab. A highly effective method of birth control is defined as one that results in a low failure rate (that is, <1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner.

排除标准

  • Breastfeeding (patients who discontinue breastfeeding would be considered eligible).

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (87)

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