Clinical Trials Directory

Trials / Completed

CompletedNCT00608868

SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients

A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
156 (actual)
Sponsor
AstraZeneca · Industry
Sex
All
Age
19 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.

Conditions

Interventions

TypeNameDescription
DRUGGefitinibGefitinib tablet 250mg once daily orally

Timeline

Start date
2007-01-01
Primary completion
2009-01-01
Completion
2009-01-01
First posted
2008-02-06
Last updated
2012-09-28
Results posted
2012-09-28

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT00608868. Inclusion in this directory is not an endorsement.

SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients (NCT00608868) · Clinical Trials Directory