Actively Recruiting
Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-09-21
49
Participants Needed
3
Research Sites
526 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Patients with primary or recurrent suspected Ta or T1, G1 or G2 (low grade) urothelial carcinoma of the bladder without suspicion of carcinoma in situ
- Patients must have between 1 and 5 lesions
- One index lesion must measure between 0.5 and 1.0 cm in greatest dimension
- Bimanual examination immediately after cystoscopy must show no mass
- Adequate kidney function (eGFR > 50 ml/min/1.73m2 according to CKD-EPI)
- Adequate liver function (bilirubin less than 1.5 times upper limit of normal, ALAT or ASAT less than 2.5 times upper limit of normal)
- Patients must be fully informed and provide written signed consent before any study procedures
- Mentally, physically, and geographically able to undergo treatment and follow-up
You will not qualify if you...
- Positive cytology suggesting high-grade urothelial carcinoma or grade 3 tumors
- Diabetes mellitus patients currently using or having used metformin in the past 6 months
- Intravesical chemotherapy or immunotherapy within the last 3 months
- Receiving other anti-cancer therapy
- Current urinary tract infection or recurrent severe bacterial cystitis
- Need for transurethral catheter treatment
- Urogenital tumors with histology other than urothelial carcinoma or involving upper tract or prostatic urethra
- History of other primary malignancy within last 5 years (except certain skin cancers or treated prostate carcinoma with normal PSA)
- Active uncontrolled impairment of renal, liver, heart, gastrointestinal, urogenital, neurologic or blood systems that increase risk from metformin
- Using certain medications without alternative options (loop diuretics, cimetidine, ranitidine, cetirizine, trimethoprim, vandetanib, kinidine, HIV medication)
- Pregnant or lactating women; individuals of reproductive potential not agreeing to effective contraception
- ECOG-WHO performance status of 3 or 4
- Known history of alcohol abuse
- Known hypersensitivity to metformin
- Inability to comply with study protocol or understand the study nature
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
RadboudUMC
Nijmegen, Gelderland, Netherlands
Not Yet Recruiting
2
Sint Franciscus Gasthuis
Rotterdam, South Holland, Netherlands
Not Yet Recruiting
3
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
Research Team
M
M. J. Remmelink, MD
CONTACT
J
J. W. Wilmink, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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