EUCTR2011-003128-11-GB进行中（未招募）1 期
Phase II trial of dasatinib in subjects with advanced cancers harboring DDR2 mutation or inactivating B-RAF mutation Pharmacogenetics Blood Amendment 1; Revised Protocol Number 01b - UK Specific - incorporating amendment 05
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
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
入选标准
- •a) Diagnosis of advanced malignancy, NSCLC only during stage 1 of accrual
- •b) Non-synonymous mutation of B-RAF or DDR2, defined as follows:
- •i) NSCLC with inactivating B-RAF mutation
- •iii) NSCLC with DDR2 mutation
- •iv) Malignancy of other histology with DDR2 mutation or inactivating B-RAF
- •mutation, or NSCLC having a B-RAF mutation which is not functionally characterized
- •c) At least one target lesion per RECIST 1.1 criteria on baseline staging evaluation
- •d) Disease progression after = 1 prior treatment regimen
- •i) Exception: Subjects with NSCLC of squamous type and DDR2 mutation may be enrolled in first line, no prior treatment is required
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •i) Pleural or pericardial effusion Grade > 1
- •i) QTcF > 470 msec (Grade = 2) or diagnosed congenital long QT syndrome
- •- Absolute granulocyte count < 1,500/mm3
- •-Hemoglobin < 10 g/dL
- •- Platelet count < 75,000/mm3
- •- Serum calcium < LLN - Hypokalemia, hypophosphatemia or hypomagnesemia Grade > 1, despite supplementation
- •- Creatinine > 3 x ULN
- •- Total bilirubin > 1.5 x ULN
- •- ALT > 3 x ULN
研究者
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