EUCTR2013-004482-14-FR进行中（未招募）不适用
A phase I/II, multicenter, open-label study of EGFRmut–TKI EGF816,administered orally in adult patients with EGFRmut solid malignancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 211
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
- •- Written informed consent must be obtained prior to any screening procedures
- •- Additionally for Phase I:
- •- Patients must have NSCLC harboring with any documented EGFR T790M mutation
- •Additionally for Phase II :
- •- Group 1: patients must have advanced NSCLC with EGFR mutation (L858R or ex19del, not T790M)
- •- Group 2: patients must have advanced NSCLC with an acquired T790M EGFR mutation
- •- Group 3: patients must have advanced NSCLC with a de novo T790M EGFR mutation.
- •- Group 4: patients must have an advanced solid tumor harboring any EGFR mutation and NOT be otherwise eligible for groups 1-3
- •- ECOG performance status = 2
- •- Presence of at least one measurable lesion according to RECIST v1.1
- •Other protocol-defined inclusion criteria may apply
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 139
排除标准
- •Phase I part only:
- •- Patient have received more than 3 previous anti-neoplastic therapies in the advanced setting
- •Phase II part only:
- •- Group 1: No limitation of previous anti-neoplastic treatments in the advanced setting
- •- Group 2: More than total of 2 previous anti-neoplastic therapies in theadvanced setting
- •- Group 3: More than total of 2 previous anti-neoplastic therapies in the advanced setting
- •- Group 4: No limitation of previous anti-neoplastic treatments in the advanced setting
- •- Patients with brain metastases
- •- Any medical condition that would, in the investigator's judgment,prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
- •- Patient have out of range laboratory values defined as:
- •Bone marrow function
- •Absolute Neutrophil Count (ANC) <1.5 x 10^9/L
- •Hemoglobin (Hgb) <9 g/dL
- •Platelets <100 x 10^9/L
- •Hepatic and renal function
- •Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome total bilirubin >2.5 x upper limit of normal (ULN).
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN
- •- Patients with tumor involvement of the liver have AST and/or ALT >5 x ULN
- •Serum creatinine >1.5 x ULN and/or measured creatinine clearance <75% LLN - Patients receiving treatment with medications that are known to be 1) strong inhibitors or inducers of CYP3A4/5; 2) CYP2D6 substrate with narrow therapeutic index
- •Other protocol-defined exclusion criteria may apply
研究者
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