Trial Outcomes & Findings for Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer (NCT NCT00923949)
NCT ID: NCT00923949
Last Updated: 2015-09-30
Results Overview
Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.
TERMINATED
PHASE2
1 participants
58 days
2015-09-30
Participant Flow
1 participant was accrued to this study.
Participant milestones
| Measure |
Pioglitazone
45 mg tablet daily by mouth for six weeks
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pioglitazone to Treat Adults Undergoing Surgery for Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=1 Participants
45 mg tablet daily by mouth for six weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
74.5 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 58 daysPopulation: No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.
Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 58 daysPopulation: No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.
Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 58 daysHere are the number of participants with adverse events. For details about the adverse events see the adverse event module.
Outcome measures
| Measure |
Pioglitazone
n=1 Participants
45 mg tablet daily by mouth for six weeks
|
|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 58 daysPopulation: No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.
Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 58 daysPopulation: No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.
Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 58 daysPopulation: No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.
ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 58 daysPopulation: No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.
C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.
Outcome measures
Outcome data not reported
Adverse Events
Pioglitazone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=1 participants at risk
45 mg tablet daily by mouth for six weeks
|
|---|---|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
1/1 • Number of events 1 • 58 days
|
|
Metabolism and nutrition disorders
ALT/SGPT (serum glutamic pyruvic transaminase)
|
100.0%
1/1 • Number of events 1 • 58 days
|
|
Metabolism and nutrition disorders
AST/SGOT (serum glutamic oxaloacetic transaminase)
|
100.0%
1/1 • Number of events 1 • 58 days
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
100.0%
1/1 • Number of events 1 • 58 days
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • 58 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place