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

ovartis Pharma Services AG0 个研究点目标入组 280 人开始时间: 2015年5月13日最近更新: 2020年7月13日

试验速览

暂无简介。

•- 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- 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

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