First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.|
- Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
- Progression Free Survival (PFS) [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.
- Overall Survival (OS) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.
- Safety Profile: Participants With Adverse Events [ Time Frame: baseline to end of study ] [ Designated as safety issue: Yes ]Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
|Study Start Date:||March 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Gefitinib 250mg tablet once daily
250mg tablet oral tablet once daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344773
|Korea, Republic of|
|Seongnam-Si, Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||HyeJong Yoo||AstraZeneca|