JPRN-jRCT2080222619已完成2 期
A Phase II, Single-arm, Japanese Multicenter Trial of TH-302 in Combination with Doxorubicin in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma(EMR 200592-008)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
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
- >= 15age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Male or female Japanese subjects greater than or equal to (>=) 15 years of age
- •2. Able to understand the purposes and risks of the trial and has signed or, if appropriate, the subject's parent or legal guardian has signed a written informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
- •3. Pathologically confirmed diagnosis of STS of the histopathologic types as specified in the protocol
- •4.Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate
- •5.Recovered from reversible toxicities of prior therapy
- •6.Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field)
- •7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •8.Life expectancy of at least 3 months
- •9. Acceptable liver function, renal function, hematologic status (without growth factor support for neutropenia or transfusion dependency), and cardiac function as specified in the protocol
- •10. All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device, intrauterine device [IUD]) with their partner from entry into the trial through 6 months after the last dose. Post-menopausal women must meet the criteria of 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels greater than (>)35 international units per liter (IU/L)
排除标准
- 未提供
研究者
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