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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
icotinib
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events

Secondary Outcome Measures

Full Information

First Posted
February 12, 2014
Last Updated
July 14, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02062515
Brief Title
Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency
Official Title
Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Icotinib is administered orally 125 mg three times per day continuously for four weeks
Intervention Type
Drug
Intervention Name(s)
icotinib
Other Intervention Name(s)
BPI-2009, Commana
Intervention Description
Icotinib is administered orally 125 mg three times per day continuously for four weeks
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Long, MD
Phone
020-87343261
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Long, MD
Organizational Affiliation
Sun Yat-sen Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long Hao, MD
Phone
020-87343261
First Name & Middle Initial & Last Name & Degree
Long Hao, MD

12. IPD Sharing Statement

Learn more about this trial

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

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