At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 49 target
Drug / intervention
Metformindrug
Likely dose
Metformin 1500 mgfrom record
Key inclusion· 9
- ✓Age over 18 years
- ✓Primary or recurrent suspected Ta or T1, G1 or G2 low-grade urothelial carcinoma of bladder without carcinoma in situ
- ✓At least 1 lesion but no more than 5
- ✓One index lesion measuring 0.5 to 1.0 cm in greatest dimension
Key exclusion· 15
- ✕Positive cytology or suspected grade 3 tumors (high-grade urothelial carcinoma)
- ✕Diabetes mellitus receiving metformin or received metformin in past 6 months
- ✕Intravesical treatment (chemotherapy or immunotherapy) within last 3 months
- ✕Currently receiving other anti-cancer therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03379909Phase 2RecruitingUpdate OverdueUpdated 33mo ago · Completion was 23mo agoEnrollment Stalled
Long Recruiting
Update Overdue
Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·interventional·Posted Dec 20, 2017·Updated Sep 21, 2023
In Brief
A Phase 2 clinical trial evaluating Metformin for Superficial Bladder Cancer and Bladder Cancer. Currently recruiting, targeting 49 participants across 3 sites.
Signals
Enrollment appears stalled
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuperficial Bladder Cancer, Bladder Cancer
CountriesNetherlands
CollaboratorsRadboud University Medical Center
Timeline
Phase 2Recruiting
2018201920202021202220232024202520262027202820292030
First PostedDec 2017
Enrollment StartSep 2019
Primary CompletionJul 2024
TodayJul 2026
Study CompletionOct 2029
First PostedDec 20, 2017
Enrollment StartSep 1, 2019
Primary CompletionJul 31, 2024
Study CompletionOct 1, 2029
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.5 years ago
Interventions
Metformindrug
Metformin orally at doses up to 1500 mg twice daily for 3 months.