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.
Age > 18 years.
Patients with primary or recurrent suspectedTa or T1, G1 or G2 (low grade) urothelial carcinoma of the bladder with no suspicion of carcinoma in situ.
Patients must have at least 1 lesion but no more than 5.
There must be one index lesion measuring between 0.5 and 1.0 cm in its greatest dimension.
Patients with positive cytology (suspected for high-grade urothelial carcinoma, TPS 4 or TPS 5) or suspected grade 3 tumours.
Patients with diabetes mellitus receiving metformin or having received metformin in the past 6 months.
Patients who have received intravesical treatment (chemotherapy or immunotherapy) within the last 3 months.
Patients that are currently receiving other anti-cancer therapy.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Radboud University Medical Center
Collaborator