Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.
In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in
patients with measurable and MET gene amplification (including gastric cancer patients).
Secondary Objectives:
To characterize and confirm the global safety profile of SAR125844 including cumulative
toxicities.
To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects
(PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the
relationship of MET gene amplification status with antitumor effects.
To evaluate other pharmacodynamic biomarkers.