A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification
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|ClinicalTrials.gov Identifier: NCT02435121|
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : March 23, 2016
To determine objective response rate (ORR).
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Malignant||Drug: SAR125844||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Given intravenously weekly at the dose of 570 mg/m^2 for at least 18 weeks
Pharmaceutical form:Concentrate for solution Route of administration: intravenous
- Determination of the objective response rate of SAR125844 as per RECIST 1.1 [ Time Frame: every 6 weeks up to 34 months ]
- Progression-free survival rate [ Time Frame: up to 34 months ]
- Overall survival rate [ Time Frame: up to 34 months ]
- Proportion of patients with adverse events [ Time Frame: up to 40 months ]
- Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax) [ Time Frame: up to 3 days ]
- Assessment of pharmacokinetic parameters: area under curve (AUC) [ Time Frame: up to 3 days ]
- Assessment of pharmacokinetic parameters: total clearance (CL) [ Time Frame: up to 3 days ]
- Assessment of pharmacokinetic parameters: half-life (t1/2) [ Time Frame: up to 3 days ]
- Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13 [ Time Frame: every 3 weeks up to 34 months ]
- Assessment of health-related quality of life by QLQ-C30/LC13 [ Time Frame: every 3 weeks up to 34 months ]
- Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire [ Time Frame: every 6 weeks up to 34 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435121
|Investigational Site Number 056001|
|Edegem, Belgium, B-2650|
|Study Director:||Clinical Sciences & Operations||Sanofi|