Overview

Phase I Clinical Study of Metatinib Tromethamine Tablet

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters. Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.
Phase:
Phase 1
Details
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.