Metformin Pharmacology in Human Cancers: A Proof of Principle Study
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03477162|
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Neoplasm||Drug: Metformin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Metformin Pharmacology in Human Cancers|
|Actual Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Patients enrolled will be treated with metformin (administered orally; 750 mg QD for 4 days, then 750 mg BID for 3-6 days; or clinically indicated metformin) for a total of 7-10 days prior to surgery, up until the night before surgery.
Metformin will be given to patients prior to surgery.
- Tumor concentration of Metformin [ Time Frame: Within 7 days from surgery ]To determine the intra-tumor concentrations of metformin, with a standard deviation ≤25% of the mean, in patients with solid tumors of thoracic origin administered metformin extended release.
- Concentration of Metformin in adipose tissue [ Time Frame: Within 7 days from surgery ]To determine the concentration of metformin in adipose tissue.
- Concentration of Metformin in tumor-adjacent normal tissue [ Time Frame: Within 7 days from surgery ]To determine the concentration of metformin in tumor-adjacent normal tissue.
- Concentration of Metformin in plasma. [ Time Frame: Within 7 days from surgery ]To determine the concentration of metformin in plasma.
- Concentration of Metformin in whole blood. [ Time Frame: Within 7 days from surgery ]To determine the concentration of metformin in whole blood.
- AMPK activity alterations. [ Time Frame: Within 7 days from surgery. ]To determine whether metformin alters AMPK activity in tumor cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477162
|Contact: Kayla Fay||603-650-8537||Kayla.A.Fay@hitchcock.org|
|Contact: Research Nurseemail@example.com|
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756|
|Contact: Kayla Fay 603-650-8537 Kayla.A.Fay@hitchcock.org|
|Contact: Research Nurse 800-639-6918 firstname.lastname@example.org|
|Principal Investigator:||Joseph Phillips, MD||Dartmouth-Hitchcock Medical Center|