Neoplasm malignant MedDRA version: 18.0 Level: PT Classification code 10028997 Term: Neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: SAR125844
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 1116743-46-4
Current Sponsor code: SAR125844
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
Exclusion criteria: Patient less than 18 years old. Eastern Cooperative Oncology Group (ECOG) performance status >2. More than 2 episodes of disease progression under anticancer therapy. Wash out period of less than 3 weeks from prior treatment with chemotherapy, radiotherapy or, surgery or any investigational treatment. Adequate hematologic, hepatic, renal, coagulation, and metabolic functions. No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade =1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03. Pregnant or breast-feeding women. Patient with reproductive potential without method of contraception. Symptomatic brain metastasis. Any clinically significant medical condition other than cancer which could interfere with the safe delivery of study treatment or risk of toxicity. Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®). Prior treatment with any MET Tyrosine Kinase Inhibitors (TKIs) or anti-MET antibodies (excluding onartuzumab). Patients treated with potent CYP3A inhibitor unless it can be discontinued. Patients treated with potent and moderate CYP3A inducers unless it can be discontinued. Mean QTc interval prolongation >470 msec.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine objective response rate (ORR).;Secondary Objective: 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 amplifcation. To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.;Primary end point(s): Determination of the objective response rate of SAR125844 as per RECIST 1.1;Timepoint(s) of evaluation of this end point: Every 6 weeks up to disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Up to 34 months Progression-free survival rate Overall survival rate Up to 40 months Proportion of patients with adverse events Up to 3 days Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax) Assessment of pharmacokinetic parameters: area under curve (AUC) Assessment of pharmacokinetic parameters: total clearance (CL) Assessment of pharmacokinetic parameters: half-life (t1/2) Every 3 weeks up to 34 months Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13 Assessment of health-related quality of life by QLQ-C30/LC13 Every 6 weeks up to 34 months Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire ;Secondary end point(s): Progression-free survival rate Overall survival rate Proportion of patients with adverse events Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax) Assessment of pharmacokinetic parameters: area under curve (AUC) Assessment of pharmacokinetic parameters: total clearance (CL) Assessment of pharmacokinetic parameters: half-life (t1/2) Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13 Assessment of health-related quality of life by QLQ-C30/LC13 Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire | — |
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Spain, Turkey, United States
Outcome results
None listed