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Trial Title:
Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency
NCT ID:
NCT02062515
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Hepatic Insufficiency
Liver Failure
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
icotinib
Description:
Icotinib is administered orally 125 mg three times per day continuously for four weeks
Arm group label:
Icotinib
Other name:
BPI-2009
Other name:
Commana
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Long Hao, MD
Phone:
020-87343261
Investigator:
Last name:
Long Hao, MD
Email:
Principal Investigator
Start date:
February 2014
Completion date:
June 2016
Lead sponsor:
Agency:
Betta Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Betta Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02062515
