| ID | Type | Description | Link |
|---|---|---|---|
| TAR-200-103 | Other Identifier | Janssen Research & Development, LLC | |
| 2017-003107-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAR-200 | Drug | TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| North Georgia Urology Center |
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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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Dalton |
| Georgia |
| 30720 |
| United States |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | United States |
| Michigan Institute of Urology | Troy | Michigan | 48084 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Urology Associates, PC | Nashville | Tennessee | 37209 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| North Austin Urology | Austin | Texas | 78750 | United States |
| Urology of Virginia, PLCC | Virginia Beach | Virginia | 23462 | United States |
| Fund. Puigvert | Barcelona | 08025 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Inst. Valenciano de Oncologia | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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