Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of IIIB/IV stage NSCLC patients who are not suitable for surgery or radiotherapy

• ECOG performance status points (PS) is 0-2

• Liver function:

A (mild hepatic dysfunction):

A1) total bilirubin within normal limit (ULN), while AST> ULN;

A2) total bilirubin within1.0-1 .5 × ULN;

B (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × ULN

• No malabsorption or other gastrointestinal disorders effecting drug absorption

• Life expectancy: more than 12 weeks.

Exclusion Criteria:

• Previous usage of HER/EGFR inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )

• Patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .

• Patients with active hepatitis and cirrhosis.