Clinical trial NCT02435121: A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasm Malignant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

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.

Primary outcomes:
measure: Determination of the objective response rate of SAR125844 as per RECIST 1.1
timeFrame: every 6 weeks up to 34 months
Secondary outcomes:
measure: Progression-free survival rate
timeFrame: up to 34 months
measure: Overall survival rate
timeFrame: up to 34 months
measure: Proportion of patients with adverse events
timeFrame: up to 40 months
measure: Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)
timeFrame: up to 3 days
measure: Assessment of pharmacokinetic parameters: area under curve (AUC)
timeFrame: up to 3 days
measure: Assessment of pharmacokinetic parameters: total clearance (CL)
timeFrame: up to 3 days
measure: Assessment of pharmacokinetic parameters: half-life (t1/2)
timeFrame: up to 3 days
measure: Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13
timeFrame: every 3 weeks up to 34 months
measure: Assessment of health-related quality of life by QLQ-C30/LC13
timeFrame: every 3 weeks up to 34 months
measure: Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire
timeFrame: every 6 weeks up to 34 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Investigational Site Number 056001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: