A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy
NCT ID: NCT03404791
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2017-11-20
2022-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants Ineligible for Radical Cystectomy
Participants will receive the TAR-200 transuretherally on Day 0 in to the bladder through an Inserter and gradually releases gemcitabine during the 21-day indwelling period before being removed on Day 21 via flexible or rigid cystoscopy. Participants will undergo an 84-day induction period comprised of four consecutive 21-day dosing cycles. Participants may undergo 21 day cycle every 3 months for a maximum of 3 cycles as maintenance (Up to 14 months). Each TAR-200 system will be removed at 21 days after insertion.
TAR-200
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.
Interventions
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TAR-200
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must have been as fully resected as possible per the physician's judgment
* Participants must be deemed unfit for RC due to comorbid conditions with a risk of mortality
* Participants must refuse or be deemed ineligible for cisplatin-based chemotherapy
* Participant must refuse or not be eligible for radiotherapy
Exclusion Criteria
* Presence of any bladder or urethral anatomic feature that in the opinion of the Investigator may prevent the safe placement, indwelling use, or removal of TAR-200
* Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed)
* Evidence of bladder perforation during diagnostic cystoscopy
* Concurrent clinically significant infections as determined by the treating Investigator
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
North Georgia Urology Center
Dalton, Georgia, United States
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Michigan Institute of Urology
Troy, Michigan, United States
University of Rochester
Rochester, New York, United States
Urology Associates, PC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
North Austin Urology
Austin, Texas, United States
Urology of Virginia, PLCC
Virginia Beach, Virginia, United States
Fund. Puigvert
Barcelona, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Inst. Valenciano de Oncologia
Valencia, , Spain
Countries
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Other Identifiers
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TAR-200-103
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003107-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108889
Identifier Type: -
Identifier Source: org_study_id
NCT04559594
Identifier Type: -
Identifier Source: nct_alias
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