KCT0003547招募中未知
Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients with Advanced Liposarcoma or Leiomyosarcoma.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated) : neoadjuvnat or adjuvant chemotherapy is counted as one regimen
- •2. ECOG(Eastern Cooperative Oncology Group) performance status of 0-2
- •3. Measurable or evaluable disease (RECIST 1.1.)
- •4. Adequate laboratory findings
- •- Hemoglobin = 9.0 g/dL
- •- Absolute neutrophil count (ANC) = 1000 /µL
- •- Platelet = 75,000/ µL
- •- Total Bilirubin: = 1.5 × UNL (upper normal limit) (= 2 × UNL in patients with liver metastasis)
- •- Serum Creatinine: =1.5 X upper limit of normal (ULN) OR = Creatinine Clearance 60 mL/min (Cockcroft-Gault) for patients with creatinine levels > 1.5 X institutional ULN
- •- AST(SGOT)/ALT(SGPT): = 3.0 × UNL or = 5.0 × UNL (in patients with liver metastasis)
- •- Alkaline Phosphatase (ALP): = 3.0 × UNL or = 5.0 × UNL (in patients with liver or bone metastasis)
- •- Prothrombin time and partial thromboplastin time (PTT) : =1.5 X ULN
- •5.Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior
排除标准
- •1. More than 3 prior cytotoxic agents
- •2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
- •3. Uncontrolled or active CNS(Central nervous system) metastasis and/or carcinomatous meningitis
- •4. Patient has known hypersensitivity to the components of study drugs or its analogs.
- •5. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- •6. Long QT Syndrome =480 ms
- •7. peripheral neuropathy =2 with previous treatment
- •8. unstable cardiovascular disease
- •9. Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray
研究者
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