Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Stomach Cancer

Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred.

Metatinib Tromethamine

Shuangling Deng, MS

Yanhua Ding, MD

Feng Bi, MD

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.

Study of Metatinib Tromethamine Tablet

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

Jiangsu Simcere Pharmaceutical Co., Ltd.

Dose escalation is in accordance with the traditional "3 +3" design, and dose groups are subsequently set as: 25, 50, 100, 200, 300, 450, 600, 800 mg/d.

Maozhi Liang, MD

You Lu, MD

Qin Yu, MD

Li Zheng, MD

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 I Clinical Study of Metatinib Tromethamine Tablet

A Phase I, Multiple Dose Escalation Clinical Trial of Metatinib Tromethamine Tablet in Patients With Advanced or Metastatic Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Metatinib Tromethamine Tablet	NCT02650375	Advanced or Met... Advanced or Met... Advanced or Met... Advanced or Met...	Metatinib Trome...	18 Years - 75 Years	Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase I Clinical Study of Metatinib Tromethamine Tablet	NCT02004548	Advanced or Met...	Metatinib Trome...	18 Years - 74 Years	Jiangsu Simcere Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for metatinib tromethamine