NCT02435121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

April 27, 2015

Last Update Submit

February 23, 2016

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

  • Determination of the objective response rate of SAR125844 as per RECIST 1.1

    every 6 weeks up to 34 months

Secondary Outcomes (10)

  • Progression-free survival rate

    up to 34 months

  • 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

  • +5 more secondary outcomes

Study Arms (1)

SAR125844

EXPERIMENTAL

Given intravenously weekly at the dose of 570 mg/m\^2 for at least 18 weeks

Drug: SAR125844

Interventions

SAR125844DRUG

Pharmaceutical form:Concentrate for solution Route of administration: intravenous

SAR125844

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 056001

Edegem, B-2650, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

SAR125844

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 6, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 23, 2016

Record last verified: 2016-02

Locations

BE(1)