JPRN-jRCT2080221635未知2 期
An Open-label, Multi-center, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects with Advanced Soft Tissue Sarcoma
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 51
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed soft tissue sarcoma of high or intermediate grade
- •- Documented evidence of advanced or metastatic soft tissue sarcoma, not amenable to surgery or radiotherapy
- •- Within 6 months from the radiographic evidence of disease progression by RECIST criteria in the last chemotherapy regimen for advanced or metastatic soft tissue sarcoma
- •- Presence of measurable disease by RECIST 1.1
- •- Subjects who received at least one standard chemotherapy for advanced soft tissue sarcoma (an anthracycline or an ifosfamide monotherapy, or a combination therapy)
- •- Subjects aged ≥20 years at the time of informed consent
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •- Adequate organ function
- •- Voluntary agreement to provide written informed consent
排除标准
- •- Any serious concomitant illness or infection requiring treatment.
- •- Hypersensitivity to either halichondrin B or halichondrin B chemical derivatives or both.
- •- Subjects who have previously participated in a study with eribulin (whether treated with eribulin or not).
- •- Any medical or other condition which, in the opinion of the principal investigator, will preclude participation in a clinical trial.
- •- Subjects who have received any anti-cancer therapy, including surgery, radiotherapy, immunotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and targeted agents within 21 days, or any investigational agent within 30 days, prior to the first dose of study drug.
- •- Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to ≤ Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy of Grade 2 and alopecia.
- •- Subjects with known cerebral metastases with clinical symptoms or requiring treatment.
- •- Pre-existing peripheral neuropathy >CTCAE Grade 2.
- •- Female subjects must not be pregnant with a negative by the pregnancy test at Screening, or breastfeeding.
- •- Subjects participating in other clinical trials
研究者
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