RecruitingPhase 2NCT03379909

Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

49 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

A multi-center, open-label, phase II clinical study of metformin in up to evaluable 49 patients with low-grade NMIBC with the aim to determine the overall response to administration of oral metformin for 3 months in a index papillary NMIBC tumour.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether metformin — a common diabetes medication — delivered directly into the bladder through a catheter (rather than taken by mouth) can help prevent the return of early-stage bladder cancer after it has been removed by cystoscopy. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with early-stage bladder cancer (stage Ta or T1, low grade) that is new or has come back - You have between 1 and 5 bladder tumors - At least one tumor measures between 0.5 cm and 1.0 cm in size - Your kidney and liver function meet the required levels **You may NOT be eligible if...** - Your cancer is suspected to be high-grade or deeply invasive into the bladder wall - You have more than 5 bladder tumors - A mass was felt in the bladder during examination under anesthesia - Your kidney function is below the required level - You have certain liver conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMetformin

Metformin orally at doses up to 1500 mg twice daily for 3 months.


Locations(3)

RadboudUMC

Nijmegen, Gelderland, Netherlands

Sint Franciscus Gasthuis

Rotterdam, South Holland, Netherlands

Academic Medical Center

Amsterdam, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03379909


Related Trials