Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients

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.

Timeline

Start

2012-09

Primary completion

2016-01

Completion

2016-01

Drugs

Indications