Phase II Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients with MET Amplificatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 168

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine objective response rate (ORR).;Secondary Objective: To assess duration of response (DR), progression free survival (PFS) and overall survival (OS).<br>To evaluate global safety profile.<br>To determine pharmacokinetic profile.<br>To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplifcation.<br>To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.;Primary end point(s): Determination of the objective response rate of SAR125844 as per RECIST 1.1;Timepoint(s) of evaluation of this end point: Every 6 weeks up to disease progression

Secondary Outcome Measures

Name	Time	Method

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