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

NCT ID: NCT02062515

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-06-30

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Icotinib

Icotinib is administered orally 125 mg three times per day continuously for four weeks

Group Type: EXPERIMENTAL

icotinib

Intervention Type: DRUG

Icotinib is administered orally 125 mg three times per day continuously for four weeks

Interventions

icotinib

Icotinib is administered orally 125 mg three times per day continuously for four weeks

Intervention Type: DRUG

Other Intervention Names

BPI-2009; Commana

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Long, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen Cancer Center

Locations

Sun Yat-sen Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Long, MD

Role: CONTACT

020-87343261

Facility Contacts

Long Hao, MD

Role: primary

020-87343261

Other Identifiers

BD-IC-IV51

Identifier Type: -

Identifier Source: org_study_id