A Phase 1 interventional study of TAR-200 in Urinary Bladder Neoplasms, sponsored by Janssen Research & Development, LLC. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: TAR-200
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.
Also known as: Gemcitabine-Releasing Intravesical System (GemRIS)
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.
Time frame: Up to Day 84
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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 12, 24, and 36 months
Plan to share: 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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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC