NCT02435121

A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR125844	Pharmaceutical form:Concentrate for solution Route of administration: intravenous

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-05-06
• Last updated: 2016-03-23

Locations

1 site across 1 country: Belgium