Metformin Pharmacology in Human Cancers: A Proof of Principle Study
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|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.
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|