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Trial record 7 of 4362 for:    "Carcinoma, Non-Small-Cell Lung"

Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC) (ReGaiN)

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ClinicalTrials.gov Identifier: NCT00824746
Recruitment Status : Completed
First Posted : January 19, 2009
Results First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Intervention Drug: Gefitinib retreatment
Enrollment 23

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gefitinib Retreatment Group
Hide Arm/Group Description Gefitinib retreatment group Patients who were previously treated with gefitinib followed by at least one line of cytotoxic chemotherapy can be enrolled to this retreatment group.
Period Title: Overall Study
Started 23
Completed 23
Not Completed 0
Arm/Group Title Single Arm
Hide Arm/Group Description Gefitinib retreatment
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  39.1%
>=65 years
14
  60.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
64.9  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
20
  87.0%
Male
3
  13.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 23 participants
23
1.Primary Outcome
Title Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT
Hide Description Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
we analysed the data of 23 patients who were enrolled to this study(intention-to-treat (ITT) population).
Arm/Group Title Gefitinib Retreatment Group
Hide Arm/Group Description:
Gefitinib retreatment
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participant with DC
65.2
(42.7 to 83.6)
2.Secondary Outcome
Title Progression - Free Survival of Patients Retreated With Gefitinib
Hide Description Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks.
Time Frame two year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gefitinib Retreatment Arm
Hide Arm/Group Description:
Gefitinib retreatment arm
Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: days
103
(70 to 134)
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
Gefitinib retreatment
Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: days
343
(235 to 409)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description Gefitinib retreatment
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%) # Events
Total   3/23 (13.04%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
disease progression   3/23 (13.04%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%) # Events
Total   10/23 (43.48%)    
Gastrointestinal disorders   
diarrhea   2/23 (8.70%)  2
Skin and subcutaneous tissue disorders   
Skin rash   8/23 (34.78%)  8
Indicates events were collected by systematic assessment
Our study has several limitations such as lack of generalizability outside a clinically and molecularly enriched population and the small number of repeat biopsies.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Young-Chul Kim, MD, PhD
Organization: Chonnam National University Hwasun Hospital
Phone: 82-61-379-7614
Responsible Party: Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT00824746     History of Changes
Other Study ID Numbers: D791JL00001
First Submitted: January 16, 2009
First Posted: January 19, 2009
Results First Submitted: February 9, 2012
Results First Posted: February 26, 2013
Last Update Posted: February 26, 2013