EUCTR2011-002569-39-BE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
- 280
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
- •- Confirmed c-MET pathway dysregulation
- •- EGFR mutated NSCLC patient who have developed acquired resistance
- •to EGFR inhibitor treatment
- •- Measurable disease as determined by RECIST version 1.1
- •-ECOG performance status =2
- •- Documented c-Met amplification
- •- Prior clinical benefit on EGFR inhibitors and then subsequent
- •progression
- •- = 18 years of age
- •- Life expectancy =3 months
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •- Previous treatment with a c-MET inhibitor or HGF-targeting therapy
- •- Previous radiation therapy completed less than 4 weeks prior to dosing
- •and, if present, any acute toxicity > grade 1
- •- history of cystic fibrosis
- •- history of acute or chronic pancreatitis, surgery of the pancreas, or any
- •risk factors that may increase the risk of pancreatitis.
- •- Unable to swallow tablets once or twice daily
- •- Any unresolved toxicity from previous anticancer therapy greater than
- •Grade 1 except alopecia.
- •- Unable to undergo an MRI or CT procedures
- •- Known history of HIV
- •- Undergone a bone marrow or solid organ transplant
- •- Pregnant or nursing
- •Other protocol exclusion criteria may apply
研究者
相似试验
进行中（未招募）
1 期
A clinical study with INC280 in combination with gefitinib in patients with non-small cell lung canceron-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002569-39-DEovartis Pharma Services AG148
进行中（未招募）
1 期
A clinical study with INC280 in combination with gefitinib in patients with non-small cell lung cancerEUCTR2011-002569-39-ITovartis Farma58
进行中（未招募）
1 期
A clinical study with INC280 in combination with gefitinib in patients with non-small cell lung cancerEUCTR2011-002569-39-FRovartis Pharma Services AG280
进行中（未招募）
1 期
A clinical study with INC280 in combination with gefitinib in patients with non-small cell lung cancerEUCTR2011-002569-39-NLovartis Pharma Services AG148
进行中（未招募）
1 期
A clinical study with INC280 in combination with gefitinib in patients with non-small cell lung cancerEUCTR2011-002569-39-ESovartis Farmacéutica S.A.58