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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
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: SAR125844 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAR125844
Given intravenously weekly at the dose of 570 mg/m^2 for at least 18 weeks
Drug: SAR125844
Pharmaceutical form:Concentrate for solution Route of administration: intravenous




Primary Outcome Measures :
  1. Determination of the objective response rate of SAR125844 as per RECIST 1.1 [ Time Frame: every 6 weeks up to 34 months ]

Secondary Outcome Measures :
  1. Progression-free survival rate [ Time Frame: up to 34 months ]
  2. Overall survival rate [ Time Frame: up to 34 months ]
  3. Proportion of patients with adverse events [ Time Frame: up to 40 months ]
  4. Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax) [ Time Frame: up to 3 days ]
  5. Assessment of pharmacokinetic parameters: area under curve (AUC) [ Time Frame: up to 3 days ]
  6. Assessment of pharmacokinetic parameters: total clearance (CL) [ Time Frame: up to 3 days ]
  7. Assessment of pharmacokinetic parameters: half-life (t1/2) [ Time Frame: up to 3 days ]
  8. Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13 [ Time Frame: every 3 weeks up to 34 months ]
  9. Assessment of health-related quality of life by QLQ-C30/LC13 [ Time Frame: every 3 weeks up to 34 months ]
  10. Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire [ Time Frame: every 6 weeks up to 34 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Locations
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Belgium
Investigational Site Number 056001
Edegem, Belgium, B-2650
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02435121    
Other Study ID Numbers: ACT14205
2014-005696-93 ( EudraCT Number )
U1111-1163-1136 ( Other Identifier: UTN )
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Neoplasms