EUCTR2015-005637-47-DK进行中（未招募）1 期
Randomized study of AZD9291 treatment of EGFR M+ NSCLC patients progressing on first line erlotinib. A study based upon detection of EGFR M+ ctDNA in plasma and urine. - RAPID
Department of Oncology, Aarhus University Hospital0 个研究点目标入组 50 人开始时间: 2017年3月1日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
- •2.Age > 18 years
- •3.Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to curative surgery or radiotherapy
- •4.Detection of T790M in blood test verified by a quantitative stable or increase in T790M level in an additional blood test taken sequential within 7 days
- •5.Prior therapy with erlotinib until point of randomization as defined by positive T790M status
- •6.World Health Organization (WHO) performance status 0-3
- •7.Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline
- •8.ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion #6
- •9.Female patients of childbearing potential must be using adequate contraceptive measures.
- •10.Male patients must be willing to use barrier contraception, i.e., condoms.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Previous (within 6 months) or current treatment with AZD9291
- •2.Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 (Appendix C)
- •3.Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, active infection including hepatitis B, hepatitis C and human immunodeficiency virus, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the investigator’s opinion would significantly alter the risk/benefit balance.
- •4.Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to start AZD9291 administration
- •5.Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- •6.Any of the following cardiac criteria:
- •a.Mean resting corrected QT interval (QTcF) > 470 ms.
- •b.Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
- •c.Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- •7.Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting treatment
- •8.History of hypersensitivity to excipients of AZD9291 or to drugs with a similar chemical structure or class to AZD9291
研究者
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