Study of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors (SARMET)
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|ClinicalTrials.gov Identifier: NCT01391533|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : April 13, 2016
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumors||Drug: SAR125844||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose Escalation, Safety, Pharmacokinetic and Pharmacodynamic, First in Man Study, of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors|
|Study Start Date :||July 2011|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
Experimental: Dose Escalation
Dose escalation phase: The starting dose of SAR125844 will be 50 mg/m^2 up to 960 mg/m^2
Route of administration: intravenous
- Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844 [ Time Frame: At day 28 of Cycle 1 of each treated patient, DLT is assessed ]
- Expansion Cohorts To evaluate the preliminary anti-tumoral effect of SAR125844 [ Time Frame: Anticancer activity is assessed at Day 28 and then every 8 weeks thereafter up to an expected maximum of 2 years ]
- Number of patients with treatment emergent events [ Time Frame: Up to 2 years ]
- Assessment of PK parameter Cmax [ Time Frame: Up to 2 years ]
- Assessment of PK parameter AUCs [ Time Frame: Up to 2 years ]
- Assessment of PK parameter CL [ Time Frame: Up to 2 years ]
- Assessment of PD parameter ShedMET [ Time Frame: Up to 2 years ]
- Assessment of PD parameter HGF [ Time Frame: Up to 2 years ]
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): NCT01391533
|United States, Massachusetts|
|Investigational Site Number 840001|
|Boston, Massachusetts, United States, 02114|
|Investigational Site Number 250002|
|Dijon, France, 21079|
|Investigational Site Number 250001|
|Villejuif, France, 94805|
|Investigational Site Number 380004|
|Bologna, Italy, 40138|
|Investigational Site Number 380002|
|Milano, Italy, 20133|
|Investigational Site Number 380001|
|Milano, Italy, 20141|
|Investigational Site Number 724001|
|Barcelona, Spain, 08035|
|Investigational Site Number 724003|
|Madrid, Spain, 28040|
|Study Director:||Clinical Sciences & Operations||Sanofi|