Metformin for endometrial cancer randomised controlled trial

Phase 1

• Conditions: Endometrial carcinoma or hyperplasia; MedDRA version: 17.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000991-25-GB
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-13
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1. Biopsy-proven type 1 endometrial carcinoma or severe atypical hyperplasia
2. Scheduled surgical treatment by hysterectomy n 5-35 days' time
3. Informed consent
4. Aged 18 years or more

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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Current treatment with metformin
2. Diabetic on hypoglycaemic medication
3. Inability to consent due to lack of capacity or language barriers
4. Unable to comply with treatment protocol
5. Type 2 endometrial cancer
6. Severe renal impairment (Serum creatinine >130umol/L or eGFR <45ml/min/1.732m2)
7. Severe hepatic impairment (abnormal LFTs to be discussed on case by case basis with hepatologist)
8. Current alcohol abuse
9. Sensitivity/hypersensitivity to biguanides
10. Current treatment with other mTOR inhibitors or chemotherapeutic agents

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether metformin has a biological effect on endometrial cancer.;<br> Secondary Objective: To evaluate the biological mechanisms of metformin treatment in endometrial cancer.<br> ;Primary end point(s): Ki-67 proliferation index (tumour analysis);Timepoint(s) of evaluation of this end point: Pre- and post- treatment with the IMP (metformin or placebo)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Physiological (blood glucose, insulin, HbA1C, adiponectin, CRP, IGF-1)<br> Tumour (cleaved caspase3, cleaved PARP, PTEN, AMPK, phospho-AMPK,<br> mTOR, S6)<br> Metformin concentration in blood and urine<br> ;Timepoint(s) of evaluation of this end point: Pre- and post- treatment with the IMP (metformin or placebo)