Effect of Metformin in patients with thyroid cancer metastasis

Phase 1

• Conditions: patients with differentiated thyroid cancer metastasis with minimally progressive development; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2020-002468-30-IT
• Lead Sponsor: ENTE OSPEDALIERO OSPEDALI GALLIERA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Age> 18 years.
2) high-risk DTC (according to ATA 2015 classification) histologically proven;
3) total thyroidectomy and previous radiometabolic therapy with 131I (administered activity between 2.96 GBq and 3.7 GBq);
4) no evidence of distant metastases at disease onset;
5) evidence of structural relapse over time treated with a second administration of RAI (activity from 5.5 GBq to 7.4 GBq).
6) absence of cancer-specific metastatic symptoms and absence of impending cancer-specific symptoms;
7) no iodine-greedy metastases after the second RAI;
8) Patients with evidence of slow disease progression (e.g. time to doubling of lung metastasis volume> 1 year) not susceptible to further surgery and candidates for active surveillance;
9) biochemical progression (i.e. increase in Tg levels in the last year).
10) preserved renal function (creatinine clearance estimated by Cockcroft-Gault formula = 60 mL / min;)
11) normal liver function (values of AST, ALT, Total Bilirubin, gammaGT and alkaline phosphatase> 1.5 times the upper limit of the normal range)
12) Signature of informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

da mettere in inglese

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Valuate the power of metformin in asymptomatic patients with high-risk DTC, i.e.<br>individuals with minimally progressive metastatic disease without specific symptoms.<br>This will be evaluated on the basis of two main endpoints:<br>1) clinical benefit rate, namely the percentage of patients with complete or partial response or with stable disease<br>2)Tg level over the time;Secondary Objective: na;Primary end point(s): 1) Progression-free survival (PFS);<br>2) Tg levels have been trending over time.;Timepoint(s) of evaluation of this end point: at least 18 months