Trial · NCT03477162
Metformin Pharmacology in Human Cancers: A Proof of Principle Study
NCT03477162, Early phase 1, Terminated, Dartmouth-Hitchcock Medical Center; results first posted 2023-10-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin Pharmacology in Human Cancers: A Proof of Principle Study. Trials, record NCT03477162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03477162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin Pharmacology in Human Cancers: A Proof of Principle Study
- NCT number
- NCT03477162
- Status
- Terminated
- Phases
- Early phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Thoracic Neoplasm
- Interventions
- Metformin
- First posted
- 2018-03-26
- Last updated
- 2023-10-03
- Results first posted
- 2023-10-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lung Tumor Tissue Concentration of Metformin | 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. |
| Secondary | Concentration of Metformin in Adipose Tissue | Within 7 days from surgery | To determine the concentration of metformin in adipose tissue. |
| Secondary | Concentration of Metformin in Tumor-adjacent Normal Tissue | Within 7 days from surgery | To determine the concentration of metformin in tumor-adjacent normal tissue. |
| Secondary | Concentration of Metformin in Plasma. | Within 7 days from surgery | To determine the concentration of metformin in plasma. |
| Secondary | Concentration of Metformin in Whole Blood. | Within 7 days from surgery | To determine the concentration of metformin in whole blood. |
| Other | AMPK Activity Alterations. | Within 7 days from surgery. | To determine whether metformin alters AMPK activity in tumor cells. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lung Tumor Tissue Concentration of Metformin | Within 7 days from surgery | Controls do not receive Metformin and are not included in this analysis. | ng/g | MEDIAN |
| SECONDARY | Concentration of Metformin in Adipose Tissue | Within 7 days from surgery | ng/g | MEDIAN | |
| SECONDARY | Concentration of Metformin in Tumor-adjacent Normal Tissue | Within 7 days from surgery | ng/g | MEDIAN | |
| SECONDARY | Concentration of Metformin in Plasma. | Within 7 days from surgery | ng/mL | MEDIAN | |
| SECONDARY | Concentration of Metformin in Whole Blood. | Within 7 days from surgery | ng/mL | MEDIAN | |
| OTHER_PRE_SPECIFIED | AMPK Activity Alterations. | Within 7 days from surgery. | AMPK activities were unable to be evaluated and no data is available. |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lung Tumor Tissue Concentration of Metformin | Metformin | 1290 | Full Range 33 to 4445 | ng/g | |
| Concentration of Metformin in Adipose Tissue | Metformin | 70 | Full Range 45 to 285 | ng/g | |
| Concentration of Metformin in Tumor-adjacent Normal Tissue | Metformin | 749 | Full Range 44 to 3013 | ng/g | |
| Concentration of Metformin in Plasma. | Metformin | 450 | Full Range 18 to 6179 | ng/mL | |
| Concentration of Metformin in Whole Blood. | Metformin | 514 | Full Range 3 to 4238 | ng/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin | 17 | |
| Overall Study | STARTED | Control | 1 | |
| Overall Study | COMPLETED | Metformin | 14 | |
| Overall Study | COMPLETED | Control | 1 | |
| Overall Study | NOT COMPLETED | Metformin | 3 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | diarrhea | Gastrointestinal disorders | Metformin | 1 | 14 | |
| other | diarrhea | Gastrointestinal disorders | Control | 0 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin | 0 | 14 |
| Total, all-cause mortality | Control | 0 | 1 |
| Total, other adverse events | Metformin | 1 | 14 |
| Total, other adverse events | Control | 0 | 1 |
| Total, serious adverse events | Metformin | 0 | 14 |
| Total, serious adverse events | Control | 0 | 1 |
Source ClinicalTrials.gov
Papers37
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metformin vs Control: deaths from any cause | Trial comparisons |
| Metformin vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03477162
GET https://conductscience.org/api/trials/v1/NCT03477162/papers?page=2