Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency
- Registration Number
- NCT02062515
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Icotinib icotinib Icotinib is administered orally 125 mg three times per day continuously for four weeks
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events Up to 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sun Yat-sen Cancer Center
🇨🇳Guangzhou, Guangdong, China