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

Phase 2

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: SAR125844

• Registration Number: NCT02435121
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-06
• Study Start: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-23
• Disposition First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Disposition First Posted: 2016-03-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR125844	SAR125844	Given intravenously weekly at the dose of 570 mg/m\^2 for at least 18 weeks

Primary Outcome Measures

Name	Time	Method
Determination of the objective response rate of SAR125844 as per RECIST 1.1	every 6 weeks up to 34 months

Secondary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetic parameters: area under curve (AUC)	up to 3 days
Overall survival rate	up to 34 months
Assessment of pharmacokinetic parameters: total clearance (CL)	up to 3 days
Assessment of pharmacokinetic parameters: half-life (t1/2)	up to 3 days
Progression-free 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

Trial Locations

Locations (1)

Investigational Site Number 056001; 🇧🇪 Edegem, Belgium