Trial Outcomes & Findings for Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00824746)
NCT ID: NCT00824746
Last Updated: 2013-02-26
Results Overview
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).
COMPLETED
PHASE2
23 participants
8 weeks
2013-02-26
Participant Flow
Participant milestones
| Measure |
Gefitinib Retreatment Group
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.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Single Arm
n=23 Participants
Gefitinib retreatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=39 Participants
|
|
Age Continuous
|
64.9 years
STANDARD_DEVIATION 7.2 • n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
|
Region of Enrollment
Korea, Republic of
|
23 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: we analysed the data of 23 patients who were enrolled to this study(intention-to-treat (ITT) population).
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).
Outcome measures
| Measure |
Gefitinib Retreatment Arm
n=23 Participants
Gefitinib retreatment arm
|
|---|---|
|
Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT
|
65.2 percentage of participant with DC
Interval 42.7 to 83.6
|
SECONDARY outcome
Timeframe: two yearProgression 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.
Outcome measures
| Measure |
Gefitinib Retreatment Arm
n=23 Participants
Gefitinib retreatment arm
|
|---|---|
|
Progression - Free Survival of Patients Retreated With Gefitinib
|
103 days
Interval 70.0 to 134.0
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Gefitinib Retreatment Arm
n=23 Participants
Gefitinib retreatment arm
|
|---|---|
|
Overall Survival
|
343 days
Interval 235.0 to 409.0
|
Adverse Events
Single Arm
Serious adverse events
| Measure |
Single Arm
n=23 participants at risk
Gefitinib retreatment
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease progression
|
13.0%
3/23 • Number of events 3 • 2 years
|
Other adverse events
| Measure |
Single Arm
n=23 participants at risk
Gefitinib retreatment
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
34.8%
8/23 • Number of events 8 • 2 years
|
|
Gastrointestinal disorders
diarrhea
|
8.7%
2/23 • Number of events 2 • 2 years
|
Additional Information
Young-Chul Kim, MD, PhD
Chonnam National University Hwasun Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60