Clinical trial · Interventional
Endometrial Cancer Biomarker Changes Following Exposure to Metformin
A Clinical Trial to Evaluate Endometrial Cancer Biomarker Changes Following Exposure to the Insulin Sensitizer Metformin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Did not obtain Health Canda approval for drug use in reasonable time and moved onward to new trial
Summary
Brief summary (as posted)
The investigators will explore the chemopreventive role of metformin. The purpose of this study is to determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa study of metformin to be used to the pre-operative period of women diagnosed with endometrial cancer by comparing their endometrial biopsy specimens taken at their initial visit and after 4-6 weeks of treatment of metformin on the day of their surgical staging.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Metformin 500 mg PO TID from time of entry to study until scheduled surgical staging operation. In cases of unresolving side effects, the metformin will be dose reduced to metformin 500 mg PO BID with evaluation after 1 week followed by withdrawal from the study if side effects persist.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Change in phosphorylated-S6
- timeFrame
- 4-6 weeks
- description
- Paired-t test will be used to determine the effect of oral metformin on the phosphorylated-S6 in pre-treatment and post-treatment endometrial samples.
Secondary outcomes (9)
- measure
- Effects of metformin on activation pathways downstream of the insulin receptor in endometrial samples by testing Ki-67
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Have a confirmed diagnosis of endometrial cancer based on an endometrial sampling though biopsy or dilatation and curettage * Must be able to undergo appropriate surgical staging for endometrial cancer * Must consent to be in the study and must have signed and dated an IRB-approved consent form conforming to government and institutional guidelines Exclusion Criteria: * Patients with a contraindication to receiving metformin treatment * Patients with cognitive impairment * Renal or hepatic functioning \> 125% upper limit of normal * Currently on medications for metabolic diseases, such as diabetes mellitus * History of lactic acidosis * Treatment with medications that may increase metformin levels: cationic drugs, e.g., digoxin, amiloride, procainamide, trimethoprim, vancomycin, triamterene, and morphine * History of chronic alcohol abuse
References
Publications (0)
Data not yet available