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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metatinib Tromethamine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metatinib Tromethamine | Drug | Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse events | until 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | every 6 weeks, up to 2 years | |
| Disease control rate | every 6 weeks, up to 2 years | |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuangling Deng, MS | Contact | 86-025-85560000 | dengshuangling@simcere.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Bi, MD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| every 6 weeks, up to 2 years |
| Overall survival | every 6 weeks, up to 2 years |
| Cmax for Metatinib | day 1,day 2,day 8,day15,day22 |
| Cmin for Metatinib | day 1,day 2,day 8,day15,day22 |
| Tmax for Metatinib | day 1,day 2,day 8,day15,day22 |
| AUC for Metatinib | day 1,day 2,day 8,day15,day22 |
| T1/2 for Metatinib | day 1,day 2,day 8,day15,day22 |
| CL for Metatinib | day 1,day 2,day 8,day15,day22 |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| The First Affiliated Hospital, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D008107 | Liver Diseases |