Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02891460
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2016-08-31
Brief Title:
Pilot Study to Evaluate the Clinical Response to Mitomycin-C in Hydrogel TC-3 Administered Intravesically in NMIBC Patients
Sponsor:
UroGen Pharma Ltd
Organization:
UroGen Pharma Ltd
Study Overview
Official Title:
Evaluation of the Clinical Response of Mitomycin-C MMC Embedded in Hydrogel TC-3 in Comparison to Mitomycin C in Saline When Administered Intravesically Pre-TURBT in Non Muscle Invasive Bladder Cancer NMIBC Patients Muscle Invasive Bladder Cancer NMIBC Patients
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the clinical response of the tumors within the bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharmas known at that time as TheraCoat Ltd TC-3 Sterile Hydrogel TC-3 and to evaluate the patency of ureters 6 hr post instillation
Detailed Description:
An open label successive dose escalation trial in subjects with Non Muscle Invasive Bladder Cancer NMIBC designed to evaluate the clinical response of low-intermediate risk tumors within the bladder to Mitomycin-C embedded in TC-3 Sterile Hydrogel TC-3 administered intravesically prior to TURBT in NMIBC subjects
Eligible subjects with NMIBC will be recruited to the trial following the initial diagnostic cystoscopy During the diagnostic cystoscopy the number of tumor lesions their size and location will be documented and recorded with video or photo cystoscopy
A baseline cystoscopy will be conducted in all subjects for the evaluation of number of tumors and their diameters and for mapping of their location Baseline blood samples for liver and renal functions as well as for complete blood count CBC and coagulation tests will be drawn prior to instillation to ensure eligibility and to serve as a reference point for systemic safety follow-up
A future TURBT has been planned for 8-10 weeks post screening Enrolled subjects will be treated successively with 40mg MMC in 40 mL TC-3 the first 6 subjects and with 80 mg MMC in 40 mL TC-3 the following 12 subjects At treatment session initiation an 18-20 Fr two-way catheter will be inserted into the subjects bladder in order to completely empty the bladder of urine Thereafter a volume of 40 mL of cooled TC-3 mixed with 40 mg or 80 mg of MMC will be instilled through the catheter into the bladder of the subject The catheter will then be ligated for twenty minutes after which it will be drawn out of the bladder and the subject was will be allowed to urinate freely
The subjects will undergo six weekly bladder instillations according to their assigned treatment of either 40 mg MMC Group A or 80 mg MMC Group B in 40 mL of TC-3 Following completion of instillation treatment series there will be a 2-4 weeks healing period prior to next follow up visit overall 10-12 weeks post screening During 2-4 weeks follow-up FU visit the lesions status will be examined under cystoscopy For subjects who will appear to have complete response CR this will be confirmed based on histological results For subjects that will not be classified as having CR decision about performance of TURBT or giving additional treatment will be at the PIs discretion
Following 2-4 week FU visit subjects will be managed according to their local standard guidelines All patients will attempt to be followed up for 12 months following 2-4 weeks FU within the trial These visits will be documented and data regarding recurrence and progression will be collected Moreover biopsy slides prior when available and following treatment will be collected and analyzed by an independent uro-pathologist
Eligible subjects with NMIBC will be recruited to the trial following the initial diagnostic cystoscopy During the diagnostic cystoscopy the number of tumor lesions their size and location will be documented and recorded with video or photo cystoscopy
A baseline cystoscopy will be conducted in all subjects for the evaluation of number of tumors and their diameters and for mapping of their location Baseline blood samples for liver and renal functions as well as for complete blood count CBC and coagulation tests will be drawn prior to instillation to ensure eligibility and to serve as a reference point for systemic safety follow-up
A future TURBT has been planned for 8-10 weeks post screening Enrolled subjects will be treated successively with 40mg MMC in 40 mL TC-3 the first 6 subjects and with 80 mg MMC in 40 mL TC-3 the following 12 subjects At treatment session initiation an 18-20 Fr two-way catheter will be inserted into the subjects bladder in order to completely empty the bladder of urine Thereafter a volume of 40 mL of cooled TC-3 mixed with 40 mg or 80 mg of MMC will be instilled through the catheter into the bladder of the subject The catheter will then be ligated for twenty minutes after which it will be drawn out of the bladder and the subject was will be allowed to urinate freely
The subjects will undergo six weekly bladder instillations according to their assigned treatment of either 40 mg MMC Group A or 80 mg MMC Group B in 40 mL of TC-3 Following completion of instillation treatment series there will be a 2-4 weeks healing period prior to next follow up visit overall 10-12 weeks post screening During 2-4 weeks follow-up FU visit the lesions status will be examined under cystoscopy For subjects who will appear to have complete response CR this will be confirmed based on histological results For subjects that will not be classified as having CR decision about performance of TURBT or giving additional treatment will be at the PIs discretion
Following 2-4 week FU visit subjects will be managed according to their local standard guidelines All patients will attempt to be followed up for 12 months following 2-4 weeks FU within the trial These visits will be documented and data regarding recurrence and progression will be collected Moreover biopsy slides prior when available and following treatment will be collected and analyzed by an independent uro-pathologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None