Clinical trial NCT03404791: 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
Official title: A Multicenter Study Evaluating Safety and Efficacy of TAR-200 in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Urinary Bladder Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-01-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate both the safety and tolerability of up to 4 dosing cycles of TAR-200 for 21 days per dosing cycle in the induction period.


Eligibility criteria: Inclusion Criteria:

* Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder
* 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:

* Other active malignancies
* 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

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 84
Secondary outcomes:
measure: Percentage of Participants with Clinical Complete Response (cCR)
timeFrame: Up to Day 360
measure: Percentage of Participants with Clinical Partial Response (cPR)
timeFrame: Up to Day 360
measure: Percentage of Participants with Stable Disease (SD)
timeFrame: Up to Day 360
measure: Percentage of Participants with Disease Progression
timeFrame: Up to Day 360
measure: Symptom Control
timeFrame: Up to Day 360
measure: Time to Intervention for Symptom Control
timeFrame: Up to Day 360
measure: Time to Progression
timeFrame: Up to Day 360
measure: Percentage of Participants Undergoing Post-treatment Interventions by 3, 6, 9, and 12 Months
timeFrame: Up to 3, 6, 9, and 12 Months
measure: Percentage of Participants Surviving at 12, 24, and 36 Months
timeFrame: At 12, 24, and 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Dalton
country: United States
facility: North Georgia Urology Center
state: Georgia
city: Hanover
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Nashville
country: United States
facility: Urology Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: North Austin Urology
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLCC
state: Virginia
city: Barcelona
country: Spain
facility: Fund. Puigvert
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Valencia
country: Spain
facility: Inst. Valenciano de Oncologia
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: