JPRN-UMIN000025930已完成未知
Prospective study for usefulness of plasma DNA on prediction of third generation EGFR tyrosine kinase inhibitors - S-PLAT study
Division of Respiratory Medicine, Saga University Hospital0 个研究点目标入组 57 人开始时间: 2017年2月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) does not meet the following all standard. 1.WBC count >= 3,000/mm3 2.Haemoglobin >= 9.0g/dL 3.Platelet count >=100,000/mm3 4.AST, ALT <=100 IU/L 5.Total bilirubin <=1.5mg/dL 6.Creatinine<=1.5mg/dL 7.SpO2 >= 90% 10) Corrected QT interval (QTc) <= 470 msec. 2. Any cytotoxic chemotherapy within 14 days of the first dose of study treatment. 3. Radiotherapy within 4 weeks of the first dose of study treatment. 4. Previously treated with osimertinib. 5. Previously treated with immune checkpoint inhibitors. 6. Patients currently receiving medications to be potent inhibitors of CYP2C8 and potent inhibitors or inducers of CYP3A4. 7. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy. 8. Brain metastases with symptoms. 9. Any evidence of severe or uncontrolled systemic diseases, including severe cardiac diseases, severe, cerebrovascular diseases, uncontrolled diabetes mellitus, hypertension, severe infection, pneumonitis, respiratory failure, active bleeding active GI bleeding, severe neurological diseases, QTc prolongation (Corrected QT interval (QTc) >470 msec) 10. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. 11. HBs antigen-positive 12. Active double cancer 13. Pregnant or possibly pregnant women, lactating women, or patients who wish to become pregnant 14. Patients who, in the opinion of the attending physician, are inappropriate for the study
研究者
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