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
Overview
- Phase
- Phase 2
- Intervention
- SAR125844
- Conditions
- Neoplasm Malignant
- Sponsor
- Sanofi
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Determination of the objective response rate of SAR125844 as per RECIST 1.1
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAR125844
Given intravenously weekly at the dose of 570 mg/m\^2 for at least 18 weeks
Intervention: SAR125844
Outcomes
Primary Outcomes
Determination of the objective response rate of SAR125844 as per RECIST 1.1
Time Frame: every 6 weeks up to 34 months
Secondary Outcomes
- 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)