Phase 1b Safety and Tolerability Study of GemRIS in NMIBC, V1.1
Research type
Research Study
Full title
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects with Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
IRAS ID
164230
Contact name
John Kelly
Contact email
Sponsor organisation
TARIS Biomedical LLC
Eudract number
2016-000099-66
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The aim of this study is to evaluate an investigational product, GemRIS, and an investigational accessory device, TARIS Inserter (used to insert GemRIS to the bladder). They will be used to study participants with recurrent low to intermediate-risk urothelial carcinoma of the bladder. GemRIS is a delivery system that delivers the drug gemcitabine hydrochloride. GemRIS is placed in the bladder and releases gemcitabine over a period of time. For this study, GemRIS is placed in the bladder for 7 days, followed by a 14-day break and then another GemRIS is placed in the bladder for 7 days. \nAlthough there are many treatment options available for non-muscle invasive bladder cancer, there is a high risk of recurrent disease and therefore new treatment options are urgently needed. Gemcitabine is a well-known drug, which is routinely used in the treatment of various cancers. Previous studies have shown that instilling gemcitabine into the bladder one to two times a week reduced tumour size. This approach may have provided some benefit, but it only exposed the tumour to gemcitabine for short time periods (1- 2 hours). GemRIS, however, allows for the slow release of gemcitabine in the bladder over a longer time period.\nThis study aims to:\nEvaluate the safety (side effects) and tolerability (how subjects feel whilst on treatment) of GemRIS. \nEvaluate how much of the study drug (gemcitabine) gets into the blood stream and how long the body takes to get rid of it.\nSee what effect the continuous release of gemcitabine has on the bladder tumour.\nParticipants will be seen in clinic several times during the study. The final visit will be 32 days after the first GemRIS insertion.\nApproximately 30 adults from two research sites in Europe are expected to participate. TARIS Biomedical LLC is sponsoring the study.\n
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0133
Date of REC Opinion
13 Apr 2016
REC opinion
Further Information Favourable Opinion