Calendario›SNY›SAR125844 · SARMET

SAR125844 · SARMET

Study of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors

Ensayo de Sanofi en Malignant Solid Tumors (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

72

previstos

Centros

8

Fin del objetivo primario

abr 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2011.

Qué mide

Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844 (At day 28 of Cycle 1 of each treated patient, DLT is assessed) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01391533), actualizada en abr 2016.