Urinary Bladder NeoplasmsPhase 1NCT03404791
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
A Phase 1 study testing TAR-200 in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 12 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- TAR-200
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 20 Nov 2017to 15 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
North Austin Urology
Austin, Texas, 78750
North Georgia Urology Center
Dalton, Georgia, 30720
Chesapeake Urology Research Associates
Hanover, Maryland, 21076
Urology Associates, PC
Nashville, Tennessee, 37209
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mayo Clinic Arizona
Phoenix, Arizona, 85054
University of Rochester
Rochester, New York, 14642
Michigan Institute of Urology
Troy, Michigan, 48084
Urology of Virginia, PLCC
Virginia Beach, Virginia, 23462
Spain3 sites
Fund. Puigvert
Barcelona, 08025
Hosp. Univ. 12 de Octubre
Madrid, 28041
Inst. Valenciano de Oncologia
Valencia, 46009
About this study
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
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.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- TAR-200
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAR-200Drug
Also called Gemcitabine-Releasing Intravesical System (GemRIS)
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.
| Study group | Role | What they receive |
|---|---|---|
| Participants Ineligible for Radical Cystectomy | Experimental | 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. Receives: Drug: TAR-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 84
Secondary outcomes (9)
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).
Measured: Up to Day 360
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).
Measured: Up to Day 360
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).
Measured: Up to Day 360
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)
Measured: Up to Day 360
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).
Measured: Up to Day 360
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.
Measured: Up to Day 360
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.
Measured: Up to Day 360
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.
Measured: Up to 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.
Measured: At 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start20 Nov 2017
- Primary completion23 Dec 2019
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404791
- Sponsor's protocol ID
- CR108889
- Other IDs
- TAR-200-103, 2017-003107-21, 2017
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2017
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03404791
- Acronym / sponsor ID
- CR108889
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Ineligible for Radical Cystectomy | Experimental | Drug: TAR-200Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAR-200Also: Gemcitabine-Releasing Intravesical System (GemRIS)TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant. | Drug | Participants Ineligible for Radical Cystectomy |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 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.
9 secondary outcomes
Percentage of Participants with Clinical Complete Response (cCR)
Time frame: Up to Day 360
Percentage of Participants with Clinical Partial Response (cPR)
Time frame: Up to Day 360
Percentage of Participants with Stable Disease (SD)
Time frame: Up to Day 360
Percentage of Participants with Disease Progression
Time frame: Up to Day 360
Symptom Control
Time frame: Up to Day 360
Time to Intervention for Symptom Control
Time frame: Up to Day 360
Time to Progression
Time frame: Up to Day 360
Percentage of Participants Undergoing Post-treatment Interventions by 3, 6, 9, and 12 Months
Time frame: Up to 3, 6, 9, and 12 Months
Percentage of Participants Surviving at 12, 24, and 36 Months
Time frame: At 12, 24, and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAR-200 in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Up to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.