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

Urinary Bladder Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404791
• Other study ID #: CR108889
• Secondary ID: TAR-200-1032017-
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

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