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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03404791
Other study ID # CR108889
Secondary ID TAR-200-1032017-
Status Completed
Phase Phase 1
First received
Last updated
Start date November 20, 2017
Est. completion date September 15, 2022

Study information

Verified date November 2022
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT04559594

Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 15, 2022
Est. primary completion date December 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
TAR-200
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.

Locations

Country Name City State
Spain Fundacion Puigvert Barcelona
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Inst. Valenciano de Oncologia Valencia
United States North Austin Urology Austin Texas
United States North Georgia Urology Center Dalton Georgia
United States Chesapeake Urology Research Associates Hanover Maryland
United States Urology Associates, PC Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Mayo Clinic Arizona Phoenix Arizona
United States University of Rochester Rochester New York
United States Michigan Institute of Urology Troy Michigan
United States Urology of Virginia, PLCC Virginia Beach Virginia

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 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. Up to Day 84
Secondary Percentage of Participants with Clinical Complete Response (cCR) 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). Up to Day 360
Secondary Percentage of Participants with Clinical Partial Response (cPR) 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). Up to Day 360
Secondary Percentage of Participants with Stable Disease (SD) 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). Up to Day 360
Secondary Percentage of Participants with Disease Progression 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) Up to Day 360
Secondary Symptom Control 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). Up to Day 360
Secondary Time to Intervention for Symptom Control 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. Up to Day 360
Secondary Time to Progression Time to progression, defined as the time from the date of the first TAR-200 insertion to the date of first occurrence of progression. Up to Day 360
Secondary Percentage of Participants Undergoing Post-treatment Interventions by 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. Up to 3, 6, 9, and 12 Months
Secondary Percentage of Participants Surviving at 12, 24, and 36 Months Percentage of participants surviving at 12, 24, and 36 months compared to all participants. At 12, 24, and 36 months
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