search
Back to results

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

Primary Purpose

Urinary Bladder Neoplasms

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAR-200
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Arizona
  • North Georgia Urology Center
  • Chesapeake Urology Research Associates
  • Michigan Institute of Urology
  • University of Rochester
  • Urology Associates, PC
  • Vanderbilt University Medical Center
  • North Austin Urology
  • Urology of Virginia, PLCC
  • Fundacion Puigvert
  • Hosp. Univ. 12 de Octubre
  • Inst. Valenciano de Oncologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants Ineligible for Radical Cystectomy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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)
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).
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.
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.
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.
Percentage of Participants Surviving at 12, 24, and 36 Months
Percentage of participants surviving at 12, 24, and 36 months compared to all participants.

Full Information

First Posted
December 28, 2017
Last Updated
November 3, 2022
Sponsor
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03404791
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants Ineligible for Radical Cystectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAR-200
Other Intervention Name(s)
Gemcitabine-Releasing Intravesical System (GemRIS)
Intervention Description
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to Day 84
Secondary Outcome Measure Information:
Title
Percentage of Participants with Clinical Complete Response (cCR)
Description
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).
Time Frame
Up to Day 360
Title
Percentage of Participants with Clinical Partial Response (cPR)
Description
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).
Time Frame
Up to Day 360
Title
Percentage of Participants with Stable Disease (SD)
Description
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).
Time Frame
Up to Day 360
Title
Percentage of Participants with Disease Progression
Description
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)
Time Frame
Up to Day 360
Title
Symptom Control
Description
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 Frame
Up to Day 360
Title
Time to Intervention for Symptom Control
Description
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 Frame
Up to Day 360
Title
Time to Progression
Description
Time to progression, defined as the time from the date of the first TAR-200 insertion to the date of first occurrence of progression.
Time Frame
Up to Day 360
Title
Percentage of Participants Undergoing Post-treatment Interventions by 3, 6, 9, and 12 Months
Description
Percentage of participants undergoing post-treatment interventions for the management of local symptoms by 3, 6, 9, and 12 months.
Time Frame
Up to 3, 6, 9, and 12 Months
Title
Percentage of Participants Surviving at 12, 24, and 36 Months
Description
Percentage of participants surviving at 12, 24, and 36 months compared to all participants.
Time Frame
At 12, 24, and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
North Georgia Urology Center
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30720
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Urology Associates, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
North Austin Urology
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Urology of Virginia, PLCC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Fundacion Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Inst. Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

We'll reach out to this number within 24 hrs