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New treatment option for Superficial Bladder Cancer
Official title Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer
ClinicalTrials.gov ID: NCT03379909
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for superficial bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Bimanual examination immediately following cystoscopyshould be carried out and no mass should be felt.
You likely can't join if
- 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.
- Patients with existing urinary tract infection or recurrent severe bacterial cystitis.
- Patients that need to be treated with a transurethral catheter.
See the full eligibility criteria
- 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.
- Bimanual examination immediately following cystoscopyshould be carried out and no mass should be felt.
- Adequate renal function (eGFR \>50 ml/min/1.73m2 according to CKD-EPI). (47)
- Adequate liver function (bilirubin \<1.5 times upper limit of normal, ALAT or ASAT \<2.5 the upper limit of normal).
- Eligible patients must be fully informed of the investigational nature of the study and written signed informed consent must be obtained prior to any study specific investigations.
- Mentally, physically, and geographically able to undergo treatment and follow up.
- 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.
- Patients with existing urinary tract infection or recurrent severe bacterial cystitis.
- Patients that need to be treated with a transurethral catheter.
- Patients with urogenital tumours with histology other than urothelial carcinoma (i.e. squamous cell or adenocarcinoma) or with urothelial carcinoma involving the upper tract or the prostatic urethra.
- Patients with a history of other primary malignancy (other than squamous or basal cell skin cancers or cone biopsied CIS of the uterine cervix or prostate carcinoma treated curatively with normal PSA values at...
- Patients with active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems that, in the opinion of the investigator, would predispose to...
- Patients who are using loop diuretics, cimetidine, ranitidine, cetirizine, trimethoprim, vandetanib, kinidine and/or HIV medication, for which no reasonable alternative is available.
- Women who are pregnant or lactating. Individuals of reproductive potential may not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partner.
- Patients with ECOG-WHO performance status of 3 or 4.
- Patients with a known history of alcohol abuse.
- Patients with a known hypersensitivity to metformin.
- Patients who in the investigator's opinion, cannot comply with provisions of the protocol or do not understand the nature of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- Rotterdam, South Holland, Netherlands
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands; Rotterdam, South Holland, Netherlands; Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.