NCT02062515

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

February 12, 2014

Last Update Submit

July 14, 2015

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events

    Up to 4 weeks

Study Arms (1)

Icotinib

EXPERIMENTAL

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

Drug: icotinib

Interventions

icotinibDRUG

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

Also known as: BPI-2009, Commana
Icotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hao Long, MD

    Sun Yat-sen Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Long, MD

CONTACT

020-87343261

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 13, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

CN(1)