Phase 2 Bladder Cancer Trial, Recruiting NCT03379909 Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT03379909
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged over 18 years
  • People who have a first-time or returning suspected low-grade bladder cancer (called Ta or T1, Grade 1 or 2 urothelial carcinoma) with no suspicion of a type called carcinoma in situ
  • People who have between 1 and 5 bladder tumours
  • People who have one main tumour measuring between 0.5 cm and 1.0 cm at its widest point
  • People whose physical examination after bladder inspection shows no detectable lump or mass
  • People whose kidneys are working well enough, based on a blood test result (eGFR above 50 ml/min/1.73m²)
  • People whose liver is working well enough, based on blood test results showing normal or near-normal levels of certain liver markers
  • People who are mentally, physically, and practically able to attend treatment and follow-up appointments
  • People who have been fully informed about the trial and have given written consent before any trial-related tests begin

Who may not be able to join:

  • People whose urine test (cytology) suggests high-grade cancer, or who are suspected of having a Grade 3 tumour
  • People with diabetes who are currently taking, or have taken, the medication metformin in the past 6 months
  • People who have received treatment directly into the bladder (such as chemotherapy or immunotherapy) in the past 3 months
  • People who are currently receiving any other cancer treatment
  • People who have an existing urinary tract infection or a history of repeated severe bladder infections caused by bacteria
  • People who need a urinary catheter as part of their ongoing care
  • People whose bladder or urinary tract cancer is of a type other than urothelial carcinoma (for example, squamous cell or adenocarcinoma), or whose urothelial cancer involves the upper urinary tract or part of the prostate
  • People who have been diagnosed with another cancer in the past 5 years, with some exceptions such as certain treated skin cancers, cervical carcinoma in situ treated by cone biopsy, or prostate cancer treated with curative intent and currently showing normal PSA levels
  • People with serious, uncontrolled problems affecting the kidneys, liver, heart, digestive system, urinary system, nervous system, or blood — where the treating doctor believes this would increase the risk of complications from taking metformin
  • People taking certain medications (including loop diuretics, cimetidine, ranitidine, cetirizine, trimethoprim, vandetanib, quinidine, or HIV medications) for which no suitable alternative is available
  • People who are pregnant or breastfeeding; people of reproductive age who are not willing to use effective contraception during the trial
  • People with a poor general health status rated at level 3 or 4 on the ECOG-WHO performance scale, meaning they have significant difficulty carrying out daily activities (confirm with trial site)
  • People with a known history of alcohol misuse
  • People with a known allergy or sensitivity to metformin
  • People who, in the opinion of the treating doctor, are unable to follow the trial requirements or do not understand what the trial involves

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 0204441376

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Registry
ClinicalTrials.gov
Start date
1 September 2019
Est. completion
31 July 2024

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Overall response

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov