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
- Conditions
- Urinary Bladder Neoplasms
- Interventions
- Drug: TAR-200
- Registration Number
- NCT03404791
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants Ineligible for Radical Cystectomy TAR-200 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability Up to Day 84 An Adverse Event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Undergoing Post-treatment Interventions by 3, 6, 9, and 12 Months Up to 3, 6, 9, and 12 Months Percentage of participants undergoing post-treatment interventions for the management of local symptoms by 3, 6, 9, and 12 months.
Percentage of Participants Surviving at 12, 24, and 36 Months At 12, 24, and 36 months Percentage of participants surviving at 12, 24, and 36 months compared to all participants.
Percentage of Participants with Clinical Complete Response (cCR) Up to Day 360 Percentage of Participants with Clinical Complete Response (cCR) will be reported as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated).
Percentage of Participants with Clinical Partial Response (cPR) Up to Day 360 Percentage of participants with clinical partial response (cPR) will be reported as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated).
Percentage of Participants with Stable Disease (SD) Up to Day 360 Percentage of participants with stable disease (SD) will be reported as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated).
Percentage of Participants with Disease Progression Up to Day 360 Percentage of participants with disease progression as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)
Symptom Control Up to Day 360 Symptom Control is defined as changes in bladder-related symptoms per the protocol-specified bladder symptom (Urinary frequency, Nocturia, Hematuria and Dysuria/pain) and toxicity grading system (Grade 0-3).
Time to Intervention for Symptom Control Up to Day 360 Time to intervention for symptom control, defined as the time from the date of the first TAR-200 insertion to the date of intervention for symptom palliation.
Time to Progression Up to Day 360 Time to progression, defined as the time from the date of the first TAR-200 insertion to the date of first occurrence of progression.
Trial Locations
- Locations (12)
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
University of Rochester
🇺🇸Rochester, New York, United States
Inst. Valenciano de Oncologia
🇪🇸Valencia, Spain
Urology of Virginia, PLCC
🇺🇸Virginia Beach, Virginia, United States
North Georgia Urology Center
🇺🇸Dalton, Georgia, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
Fundacion Puigvert
🇪🇸Barcelona, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Chesapeake Urology Research Associates
🇺🇸Hanover, Maryland, United States
Urology Associates, PC
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
North Austin Urology
🇺🇸Austin, Texas, United States