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Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01717482
Recruitment Status : Terminated (Poor accrual and funding ended)
First Posted : October 30, 2012
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Interventions Drug: Metformin
Other: Placebo Comparator
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin Observation
Hide Arm/Group Description

Metformin 850mg twice per day

Metformin

Standard of Care Observation

Placebo Comparator: Standard of Care Observation

Period Title: Overall Study
Started 4 2
Completed 0 2
Not Completed 4 0
Arm/Group Title Metformin Observation Total
Hide Arm/Group Description

Metformin 850mg twice per day

Metformin

Standard of Care Observation

Placebo Comparator: Standard of Care Observation

Total of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 2 participants 6 participants
63.25  (6.87) 62.5  (7.5) 63  (7.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
2
  50.0%
0
   0.0%
2
  33.3%
Male
2
  50.0%
2
 100.0%
4
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
2
 100.0%
6
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 2 participants 6 participants
4 2 6
1.Primary Outcome
Title Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to poor accrual and funding ended
Arm/Group Title Metformin Observation
Hide Arm/Group Description:

Metformin 850mg twice per day

Metformin

Standard of Care Observation

Placebo Comparator: Standard of Care Observation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants With 2-year Recurrence Free Survival
Hide Description To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
Time Frame 4 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)
Hide Description 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.
Time Frame 4 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety
Hide Description To compare participant adverse events between metformin and observation arms using CTCAE version 4.
Time Frame 4 years
Outcome Measure Data Not Reported
Time Frame Adverse Events were collected over a 24 months time period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Observation
Hide Arm/Group Description

Metformin 850mg twice per day

Metformin

Standard of Care Observation

Placebo Comparator: Standard of Care Observation

All-Cause Mortality
Metformin Observation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Metformin Observation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Observation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/2 (0.00%)    
Gastrointestinal disorders     
Constipation   1/4 (25.00%)  1 0/2 (0.00%)  0
Bloating   1/4 (25.00%)  1 0/2 (0.00%)  0
General disorders     
Nausea   1/4 (25.00%)  1 0/2 (0.00%)  0
Dizziness   1/4 (25.00%)  1 0/2 (0.00%)  0
Back Pain   1/4 (25.00%)  1 0/2 (0.00%)  0
Abdominal Pain   1/4 (25.00%)  1 0/2 (0.00%)  0
Stomach pain   1/4 (25.00%)  1 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleual Effusion   1/4 (25.00%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dennis Wigle, M.D., Ph.D.
Organization: Mayo Clinic
Phone: 507-284-8462
EMail: Wigle.Dennis@mayo.edu
Layout table for additonal information
Responsible Party: Dennis Wigle, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01717482    
Other Study ID Numbers: 12-006865
First Submitted: October 25, 2012
First Posted: October 30, 2012
Results First Submitted: May 28, 2019
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019