First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
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|ClinicalTrials.gov Identifier: NCT00344773|
Recruitment Status : Completed
First Posted : June 27, 2006
Results First Posted : June 4, 2010
Last Update Posted : June 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Cancer||Drug: Gefitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Gefitinib 250mg tablet once daily
250mg tablet oral tablet once daily
- 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 ]
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 ]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 ]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 ]Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344773
|Korea, Republic of|
|Seongnam-Si, Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||HyeJong Yoo||AstraZeneca|