Neoplasm Malignant
Conditions
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.
Interventions
DRUGSAR125844
Pharmaceutical form:Concentrate for solution Route of administration: intravenous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the objective response rate of SAR125844 as per RECIST 1.1 | every 6 weeks up to 34 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 pharmacokinetic parameters: area under curve (AUC) | up to 3 days |
| Progression-free survival rate | up to 34 months |
| Assessment of pharmacokinetic parameters: half-life (t1/2) | 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 |
| Assessment of pharmacokinetic parameters: total clearance (CL) | up to 3 days |
Countries
Belgium
Outcome results
None listed