Study of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors
- Registration Number
- NCT01391533
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of SAR125844 when administered as single agent at the MTD.
To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer \[NSCLC\] patients) and in patients with Phospho-MET positive tumors without MET-gene amplification.
Secondary Objectives:
To characterize the global safety profile including cumulative toxicities. To evaluate the pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s).
To assess preliminary antitumor activity in patients with measurable/evaluable disease, according to RECIST 1.1 criteria.
To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study, in the escalation part only.
To evaluate other pharmacodynamic biomarkers and help selection of patients who could benefit from SAR125844.
To explore MET-gene amplification status in circulating DNA.
- Detailed Description
The duration of the study for one patient in the dose escalation phase of the study will include a screening period of up to 3 weeks and a 4-week treatment cycle(s). The patients may continue treatment until disease progression, unacceptable toxicity, or willingness to stop, followed by a minimum of 30-day follow-up. The study will also include 2 expansion cohorts. If a patient treated in dose escalation part or in an expansion cohorts, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment for a maximum of 1 year and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation SAR125844 Dose escalation phase: The starting dose of SAR125844 will be 50 mg/m\^2 up to 960 mg/m\^2
- Primary Outcome Measures
Name Time Method Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844 At day 28 of Cycle 1 of each treated patient, DLT is assessed Expansion Cohorts To evaluate the preliminary anti-tumoral effect of SAR125844 Anticancer activity is assessed at Day 28 and then every 8 weeks thereafter up to an expected maximum of 2 years
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter Cmax Up to 2 years Assessment of PD parameter ShedMET Up to 2 years Assessment of PK parameter AUCs Up to 2 years Assessment of PK parameter CL Up to 2 years Number of patients with treatment emergent events Up to 2 years Assessment of PD parameter HGF Up to 2 years
Trial Locations
- Locations (8)
Investigational Site Number 840001
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 380001
🇮🇹Milano, Italy
Investigational Site Number 250002
🇫🇷Dijon, France
Investigational Site Number 250001
🇫🇷Villejuif, France
Investigational Site Number 724001
🇪🇸Barcelona, Spain
Investigational Site Number 380004
🇮🇹Bologna, Italy
Investigational Site Number 380002
🇮🇹Milano, Italy
Investigational Site Number 724003
🇪🇸Madrid, Spain