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Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Hepatic Insufficiency
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: icotinib
Type: Drug
Overall Status
Recruiting
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.
Detailed Description
Patients with hepatic insufficiency is an important subgroup of who receive EGFR TKIs. Phase I/II studies showed that Icotinib has good security. Based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed NSCLC patients with hepatic insufficiency.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Location
Sun Yat-sen Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Long Hao, MD - 020-87343261
Start Date
February 2014
Completion Date
June 2016
Sponsors
Betta Pharmaceuticals Co.,Ltd.
Source
Betta Pharmaceuticals Co.,Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page