A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification

Neoplasm Malignant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435121
• Other study ID #: ACT14205
• Secondary ID: 2014-005696-93U1
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2015
• Last updated: February 11, 2016
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Drug:
• SAR125844
Pharmaceutical form:Concentrate for solution Route of administration: intravenous

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056001	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the objective response rate of SAR125844 as per RECIST 1.1		every 6 weeks up to 34 months	No
Secondary	Progression-free survival rate		up to 34 months	No
Secondary	Overall survival rate		up to 34 months	No
Secondary	Proportion of patients with adverse events		up to 40 months	Yes
Secondary	Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)		up to 3 days	No
Secondary	Assessment of pharmacokinetic parameters: area under curve (AUC)		up to 3 days	No
Secondary	Assessment of pharmacokinetic parameters: total clearance (CL)		up to 3 days	No
Secondary	Assessment of pharmacokinetic parameters: half-life (t1/2)		up to 3 days	No
Secondary	Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13		every 3 weeks up to 34 months	No
Secondary	Assessment of health-related quality of life by QLQ-C30/LC13		every 3 weeks up to 34 months	No
Secondary	Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire		every 6 weeks up to 34 months	No