Clinical trial · Interventional
An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin
An Open-Labeled Pilot Study of Biomarker Response in Patients With Colorectal Cancer or Endoscopically Non-Resectable Adenomas Following Short-Term Exposure to Metformin Extended Release (ER)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied. Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin ER | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin + Colon Surgery
- description
- Patients randomized to Metformin-ER 500 mg once daily for one week and then escalation to 1000 mg/day for the duration of the trial. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.
- interventionNames
- Drug: Metformin ER
- type
- NO_INTERVENTION
- label
- Colon Surgery Alone
- description
- Patients will not receive any study drug from the time of colonoscopy until surgery.
Primary outcomes (1)
- measure
- Comparison of Ki-67 in Tumor Samples
- timeFrame
- 2 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18- 75 years 2. Colonic lesion that should be removed surgically: 3. 2.a. CRC that is potentially resectable and not requiring neoadjuvant treatment. 4. 2.b. Endoscopically non-resectable adenoma. 5. 2.c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy. 6. Need for perioperative colonoscopy as a part of standard of care evaluation: 7. 6.a. CRC or adenoma for which the colorectal surgeon requires a preoperative colonoscopy or sigmoidoscopy for any reason, including but not limited to: 8. 6.a.a. No outside colonoscopy 9. 6.a.b. No outside pathology 10. 6.a.c. Partially obstructing tumor or 11. 6.a.d. Otherwise unsatisfactory outside colonoscopy 12. 6.a.e. Rectal cancer requiring EUS 13. 6.a.f. Second opinion on adenoma regarded as endoscopically non-resectable on outside colonoscopy; or 14. 6.b. Patient found on initial MDACC colonoscopy to have CRC or endoscopically non-resectable adenoma, most commonly patients undergoing average or high risk (familial, history of adenoma) screening colonoscopy. 15. Ability to give informed consent. 16. Diabetic patients are eligible but they may be excluded if they are taking Metformin, insulin or sulfonylureas. Exclusion Criteria: 1. Patients with renal insufficiency defined as serum creatinine \>= 1.4 mg/dl for females and \>= 1.5 mg/dl for males 2. Pregnant or nursing women 3. A malignancy currently under active therapy 4. Unstable angina 5. Uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification) 6. Current usage of Metformin 7. Current usage of insulin, sulfonylureas 8. History of lactic acidosis 9. Chronic liver disease or cirrhosis 10. Inability to give informed consent 11. Other investigational drugs within the past one year or concurrently 12. Known hypersensitivity or intolerance to Metformin
References
Publications (0)
Data not yet available