Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients with Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification

Sanofi-aventis recherche & développement0 个研究点目标入组 168 人开始时间: 2015年6月3日最近更新: 2016年8月8日

研究概览

暂无简介。

•Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by
•Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
•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 112
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•Patient less than 18 years old.
•Eastern Cooperative Oncology Group (ECOG) performance status >2.
•More than 2 episodes of disease progression under anticancer therapy.
•Wash out period of less than 3 weeks from prior treatment with chemotherapy, radiotherapy or, surgery or any investigational treatment.
•Adequate hematologic, hepatic, renal, coagulation, and metabolic functions.
•No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade =1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.
•Pregnant or breast-feeding women.
•Patient with reproductive potential without method of contraception.
•Symptomatic brain metastasis.
•Any clinically significant medical condition other than cancer which could interfere with the safe delivery of study treatment or risk of toxicity.
•Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®).
•Prior treatment with any MET Tyrosine Kinase Inhibitors (TKIs) or anti-MET antibodies (excluding onartuzumab).
•Patients treated with potent CYP3A inhibitor unless it can be discontinued.
•Patients treated with potent and moderate CYP3A inducers unless it can be discontinued.
•Mean QTc interval prolongation >470 msec.

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