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临床试验/NCT02435121
NCT02435121已完成2 期

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

Sanofi1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Sanofi
入组人数
1
试验地点
1
主要终点
Determination of the objective response rate of SAR125844 as per RECIST 1.1

研究概览

简要总结

Primary Objective:

To determine objective response rate (ORR).

Secondary Objectives:

To assess duration of response (DR), progression free survival (PFS) and overall survival (OS).

To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplification.

To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.

详细描述

The duration of the study for 1 patient will include a screening period of up to 3 weeks, a 3-week treatment cycle(s) and a follow-up period. The patients will be treated for 6 cycles in case no response is observed, and treatment may be continued beyond 6 cycles in case of partial response/complete response (PR/CR) or significant clinical benefit until progressive disease, unacceptable toxicity, willingness to stop the study treatment or until study termination by sponsor. After the completion of the study treatment each patient will be followed every 6 weeks until death or the study cut-off date, whichever comes first. For patients who went-off study treatment prior disease progression is documented, date of disease progression and further anticancer treatment will be collected in follow-up visit.

The cut-off date corresponds to the date at which all the treated patients will have 3 post-baseline tumor assessments or will early discontinue whatever the reason. Beyond cut-off date, patient can continue study treatment until disease progression, unacceptable toxicity or patient's refusal, provided clinical benefit is established.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

SAR125844

Experimental

Given intravenously weekly at the dose of 570 mg/m^2 for at least 18 weeks

干预措施: SAR125844 (Drug)

结局指标

主要结局

Determination of the objective response rate of SAR125844 as per RECIST 1.1

时间窗: every 6 weeks up to 34 months

次要结局

  • Assessment of pharmacokinetic parameters: total clearance (CL)(up to 3 days)
  • Assessment of pharmacokinetic parameters: half-life (t1/2)(up to 3 days)
  • Assessment of pharmacokinetic parameters: area under curve (AUC)(up to 3 days)
  • Progression-free survival rate(up to 34 months)
  • Overall survival rate(up to 34 months)
  • Proportion of patients with adverse events(up to 40 months)
  • Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)(up to 3 days)
  • Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13(every 3 weeks up to 34 months)
  • Assessment of health-related quality of life by QLQ-C30/LC13(every 3 weeks up to 34 months)
  • Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire(every 6 weeks up to 34 months)

研究者

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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