NCT03379909

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multi-center, open-label, phase II clinical study of metformin in up to 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 tumour (0.5-1 cm) selected ane measured during cystoscopy. All patients will receive metformin orally at doses up to 1500 mg twice daily. Metformin treatment will start directly after informed consent is obtained. After 3 months of metformin treatment, the effect of metformin on the index lesion is evaluated by performing a transurethral resection of the bladder tumour under anaesthesia. Residual tumour, if present at this evaluation, will be resected. In case of complete disappearance of the index lesion the former tumour area will be biopsied.

Conditions

• Superficial Bladder Cancer
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Metformin	Metformin orally at doses up to 1500 mg twice daily for 3 months.

Timeline

• Start date: 2019-09-01
• Primary completion: 2024-07-31
• Completion: 2029-10-01
• First posted: 2017-12-20
• Last updated: 2023-09-21

Locations

3 sites across 1 country: Netherlands