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Brief Title: Study of Metatinib Tromethamine Tablet
Official Title: A Phase Ib Clinical Study of the Tolerance, Safety and Preliminary Efficacy Observation of Single-/Multiple- Doses of Metatinib Tromethamine Tablets in Patients With Advanced or Metastatic Solid Tumor
Study ID: NCT02650375
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Bethune Hospital of Jilin University, Changchun, Jilin, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China
Name: Feng Bi, MD
Affiliation: West China Hospital
Role: PRINCIPAL_INVESTIGATOR