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

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02062515
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
28
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study
Study Start Date :
Feb 1, 2014
Anticipated Primary Completion Date :
Feb 1, 2016
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

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

Drug: icotinib
Icotinib is administered orally 125 mg three times per day continuously for four weeks
Other Names:
  • BPI-2009
  • Commana

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events [Up to 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Principal Investigator: Hao Long, MD, Sun Yat-sen Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02062515
    Other Study ID Numbers:
    • BD-IC-IV51
    First Posted:
    Feb 13, 2014
    Last Update Posted:
    Jul 15, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Hepatic Insufficiency
    Liver Failure

    Study Results

    No Results Posted as of Jul 15, 2015