Trial Outcomes & Findings for Metformin Pharmacology in Human Cancers: A Proof of Principle Study (NCT NCT03477162)

NCT ID: NCT03477162

Last Updated: 2023-10-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Within 7 days from surgery

Results posted on

2023-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Metformin Patients given Metformin prior to surgery	Control Patient not given metformin prior to surgery
Overall Study STARTED	17	1
Overall Study COMPLETED	14	1
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin Pharmacology in Human Cancers: A Proof of Principle Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin n=14 Participants Patients given Metformin prior to surgery	Control n=1 Participants Patient not given metformin prior to surgery	Total n=15 Participants Total of all reporting groups
Age, Continuous	70.9 years STANDARD_DEVIATION 6.0 • n=5 Participants	75 years n=7 Participants	70.9 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (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	14 participants n=5 Participants	1 participants n=7 Participants	15 participants n=5 Participants
Subject already taking metformin at time of study entry	13 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days from surgery

Population: Controls do not receive Metformin and are not included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Metformin n=14 Participants Patients given Metformin prior to surgery
Lung Tumor Tissue Concentration of Metformin	1290 ng/g Interval 33.0 to 4445.0

SECONDARY outcome

Timeframe: Within 7 days from surgery

To determine the concentration of metformin in adipose tissue.

Outcome measures

Outcome measures
Measure	Metformin n=11 Participants Patients given Metformin prior to surgery
Concentration of Metformin in Adipose Tissue	70 ng/g Interval 45.0 to 285.0

SECONDARY outcome

Timeframe: Within 7 days from surgery

To determine the concentration of metformin in tumor-adjacent normal tissue.

Outcome measures

Outcome measures
Measure	Metformin n=12 Participants Patients given Metformin prior to surgery
Concentration of Metformin in Tumor-adjacent Normal Tissue	749 ng/g Interval 44.0 to 3013.0

SECONDARY outcome

Timeframe: Within 7 days from surgery

To determine the concentration of metformin in plasma.

Outcome measures

Outcome measures
Measure	Metformin n=12 Participants Patients given Metformin prior to surgery
Concentration of Metformin in Plasma.	450 ng/mL Interval 18.0 to 6179.0

SECONDARY outcome

Timeframe: Within 7 days from surgery

To determine the concentration of metformin in whole blood.

Outcome measures

Outcome measures
Measure	Metformin n=14 Participants Patients given Metformin prior to surgery
Concentration of Metformin in Whole Blood.	514 ng/mL Interval 3.0 to 4238.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 7 days from surgery.

Population: AMPK activities were unable to be evaluated and no data is available.

To determine whether metformin alters AMPK activity in tumor cells.

Outcome measures

Outcome data not reported

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Metformin n=14 participants at risk Patients given Metformin prior to surgery	Control n=1 participants at risk Patient not given metformin prior to surgery
Gastrointestinal disorders diarrhea	7.1% 1/14 • Events were collected from the time of consent until the day after surgery	0.00% 0/1 • Events were collected from the time of consent until the day after surgery

Additional Information

Joseph Phillips, MD

Dartmouth Hitchcock Medical Center

Phone: 603-650-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place