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

ConditionsSuperficial Bladder CancerBladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Metformin

    Drug

    Metformin orally at doses up to 1500 mg twice daily for 3 months.

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response

The primary outcome is the objective response rate (complete responses) after 3 months of treatment with metformin. Evaluable patients are those who have received at least 500 mg metformin twice daily for one week and who undergo a cystoscopy for marker lesion removal.

Time frame
3 months

Secondary outcomes

1

Time to recurrence

The duration of the time to recurrence of NMIBC after stopping metformin treatment. Patients will be followed for a maximum duration of 5 years.

Time frame
5 years
2

Toxicity of metformin treatment

The number of grade 1-4 and grade 5 (fatal) NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) events during treatment with metformin. All patients will be evaluable for toxicity from the time of their first treatment with metformin.

Time frame
3 months
3

Partial response

At least 30% reduction in the longest diameter of the marker lesion.

Time frame
3 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Radboud University Medical Center

Collaborator

Source ClinicalTrials.gov
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