Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer
TROJAN
1 other identifier
interventional
49
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2019
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2017
CompletedFirst Posted
Study publicly available on registry
December 20, 2017
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
ExpectedSeptember 21, 2023
September 1, 2023
4.9 years
December 16, 2017
September 19, 2023
Conditions
Keywords
Outcome Measures
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.
3 months
Secondary Outcomes (3)
Time to recurrence
5 years
Toxicity of metformin treatment
3 months
Partial response
3 months.
Study Arms (1)
Treatment arm
EXPERIMENTALMetformin orally at doses up to 1500 mg twice daily for 3 months.
Interventions
Eligibility Criteria
You may qualify 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.
- 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.
You may not qualify 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.
- 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 active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems that, in the opinion of the investigator, would predispose to the development of complications from the administration of metformin.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
RadboudUMC
Nijmegen, Gelderland, Netherlands
Sint Franciscus Gasthuis
Rotterdam, South Holland, Netherlands
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Related Publications (1)
Molenaar RJ, van Hattum JW, Brummelhuis IS, Oddens JR, Savci-Heijink CD, Boeve ER, van der Meer SA, Witjes JF, Pollak MN, de Reijke TM, Wilmink JW. Study protocol of a phase II clinical trial of oral metformin for the intravesical treatment of non-muscle invasive bladder cancer. BMC Cancer. 2019 Nov 21;19(1):1133. doi: 10.1186/s12885-019-6346-1.
PMID: 31752752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncologist, Associate Professor
Study Record Dates
First Submitted
December 16, 2017
First Posted
December 20, 2017
Study Start
September 1, 2019
Primary Completion
July 31, 2024
Study Completion (Estimated)
October 1, 2029
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share