Trial Outcomes & Findings for Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer (NCT NCT01717482)
NCT ID: NCT01717482
Last Updated: 2020-03-10
Results Overview
To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.
TERMINATED
PHASE2
6 participants
2 years
2020-03-10
Participant Flow
Participant milestones
| Measure |
Metformin
Metformin 850mg twice per day
Metformin
|
Observation
Standard of Care Observation
Placebo Comparator: Standard of Care Observation
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Metformin
n=4 Participants
Metformin 850mg twice per day
Metformin
|
Observation
n=2 Participants
Standard of Care Observation
Placebo Comparator: Standard of Care Observation
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.25 years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
63 years
STANDARD_DEVIATION 7.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Study terminated due to poor accrual and funding ended
To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 yearsPopulation: Study terminated due to poor accrual and funding ended
To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Study terminated due to poor accrual and funding ended
To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: Study terminated due to poor accrual and funding ended
To compare participant adverse events between metformin and observation arms using CTCAE version 4.
Outcome measures
Outcome data not reported
Adverse Events
Metformin
Observation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin
n=4 participants at risk
Metformin 850mg twice per day
Metformin
|
Observation
n=2 participants at risk
Standard of Care Observation
Placebo Comparator: Standard of Care Observation
|
|---|---|---|
|
General disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
|
General disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
|
General disorders
Back Pain
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
|
General disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
|
Respiratory, thoracic and mediastinal disorders
Pleual Effusion
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
|
General disorders
Stomach pain
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
|
Gastrointestinal disorders
Bloating
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected over a 24 months time period
|
0.00%
0/2 • Adverse Events were collected over a 24 months time period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place