Metformin in non-diabetic women with endometrial cancer

Proof of mechanism pre-surgical window trial of metformin in non-diabetic women with endometrial carcinoma: a feasibility study - Metformin in non-diabetic women with endometrial cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001382-40-GB

Enrollment

Registered

2011-08-11

Start date

2011-09-09

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial carcinoma or hyperplasia MedDRA version: 14.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Metformin hydrochloride Product Name: Metformin hydrochloride Product Code: N/A Pharmaceutical Form: Tablet INN or Proposed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biopsy-proven endometrial cancer or hyperplasia (precancer) 2. Scheduled for surgical treatment (hysterectomy and removal of both ovaries) in 2 or more weeks time 3. Written informed consent to participate in the trial 4. Aged over 18 years old Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Already receiving metformin treatment 2. Type 1 or type 2 diabetes mellitus 3. Renal or hepatic impairment 4. Unable to comply with treatment protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether metformin exerts any effect in endometrial cancer.; Secondary Objective: To evaluate the biological mechanisms of metformin treatment in endometrial cancer. ;Primary end point(s): Ki-67 expression by the tumour (a proliferation marker);Timepoint(s) of evaluation of this end point: Laboratory analyses will be completed following collection of endometrial tissue samples. Tissue will be processed, stored and analysed on an ongoing basis throughout the trial.	—

Measure

Time frame

Main Objective: To determine whether metformin exerts any effect in endometrial cancer.; Secondary Objective: To evaluate the biological mechanisms of metformin treatment in endometrial cancer. ;Primary end point(s): Ki-67 expression by the tumour (a proliferation marker);Timepoint(s) of evaluation of this end point: Laboratory analyses will be completed following collection of endometrial tissue samples. Tissue will be processed, stored and analysed on an ongoing basis throughout the trial.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Laboratory analyses will be completed following collection of endometrial tissue samples. Tissue will be processed, stored and analysed on an ongoing basis throughout the trial.; Secondary end point(s): Tumour analyses: Cleaved caspase3 and cleaved PARP (apoptosis markers); PTEN, AMPK, phosphoAMPK, mTOR and S6 phosphorylation (signal transduction pathways) Physiological analyses: Fasting serum glucose, insulin, IGFBP1 and Cpeptide levels IR and phosphorylated IR expression Tolerability of metformin treatment	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Laboratory analyses will be completed following collection of endometrial tissue samples. Tissue will be processed, stored and analysed on an ongoing basis throughout the trial.; Secondary end point(s): Tumour analyses: Cleaved caspase3 and cleaved PARP (apoptosis markers); PTEN, AMPK, phosphoAMPK, mTOR and S6 phosphorylation (signal transduction pathways) Physiological analyses: Fasting serum glucose, insulin, IGFBP1 and Cpeptide levels IR and phosphorylated IR expression Tolerability of metformin treatment

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Countries

United Kingdom

Contacts

Public ContactResearch Office

Central Manchester University Hospitals NHS Foundation Trust

research.secretary@cmft.nhs.uk+4401612763565

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026