EUCTR2011-002569-39-IT进行中（未招募）1 期
A phase IB/II, open label, multicenter study of INC280 administered orally in combination with gefitinib in adult patients with EGFR mutated, c-MET-amplified non-small cell lung cancer who have progressed after EGFR inhibitor treatment
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
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
- •- Documented EGFR mutation
- •- Documented c-MET amplification
- •- Prior clinical benefit on EGFR inhibitors and then subsequent progression
- •- = 18 years of age
- •- Life expectancy =3 months
- •- ECOG performance status = 2
- •Other protocol 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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •- Unable to swallow tablets once or twice daily
- •- Previous treatment with a c-MET inhibitor
- •- Any unresolved toxicity from previous anticancer therapy greater than Grade 1
- •- history of cystic fibrosis
- •- history of acute or chronic pancreatitis
- •- Unable to undergo an MRI or CT scans
- •- Known history of HIV
- •- Undergone a bone marrow or solid organ transplant
- •- Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
- •- Pregnant or nursing
- •Other protocol exclusion criteria may apply
研究者
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