drugset / Trial / NCT02650375

Study of Metatinib Tromethamine Tablet

NCT02650375 ↗

Phase 1 Unknown 24 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter study designed to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC. Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred. The study will determine whether MET gene mutation, amplification, as well as MET protein overexpression in tumor tissue correlate with treatment efficacy and clinical outcome. The potential PD biomarker for Metatinib will also be explored.

Timeline

Start
2015-10
Primary completion
2017-10
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Metatinib Unknown 100 mg Oral
Subject Metatinib Unknown 200 mg Oral