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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02062515
• Other study ID #: BD-IC-IV51
• Status: Recruiting
• Phase: Phase 2
• First received: February 12, 2014
• Last updated: July 14, 2015
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Hao Long, MD
• Phone: 020-87343261
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Hepatic Insufficiency
• Non-small Cell Lung Cancer

Intervention

Drug:
• icotinib
Icotinib is administered orally 125 mg three times per day continuously for four weeks

Locations

Country	Name	City	State
China	Sun Yat-sen Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events		Up to 4 weeks	No