Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CR108889
- SECONDARY ID:
TAR-200-103
- SECONDARY ID:
2017-003107-21
- NCT ID:
NCT03404791
- NCT ALIAS:
NCT04559594
Conditions
- Urinary Bladder Neoplasms
Interventions
| Drug | Synonyms | Arms |
|---|
| TAR-200 | Gemcitabine-Releasing Intravesical System (GemRIS) | Participants Ineligible for Radical Cystectomy |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
| Time Frame: | Up to Day 84 |
| Safety Issue: | |
| 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. |
Secondary Outcome Measures
| Measure: | Percentage of Participants with Clinical Complete Response (cCR) |
| Time Frame: | Up to Day 360 |
| Safety Issue: | |
| 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). |
| Measure: | Percentage of Participants with Clinical Partial Response (cPR) |
| Time Frame: | Up to Day 360 |
| Safety Issue: | |
| 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). |
| Measure: | Percentage of Participants with Stable Disease (SD) |
| Time Frame: | Up to Day 360 |
| Safety Issue: | |
| 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). |
| Measure: | Percentage of Participants with Disease Progression |
| Time Frame: | Up to Day 360 |
| Safety Issue: | |
| 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) |
| Measure: | Symptom Control |
| Time Frame: | Up to Day 360 |
| Safety Issue: | |
| 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). |
| Measure: | Time to Intervention for Symptom Control |
| Time Frame: | Up to Day 360 |
| Safety Issue: | |
| 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. |
| Measure: | Time to Progression |
| Time Frame: | Up to Day 360 |
| Safety Issue: | |
| 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. |
| Measure: | Percentage of Participants Undergoing Post-treatment Interventions by 3, 6, 9, and 12 Months |
| Time Frame: | Up to 3, 6, 9, and 12 Months |
| Safety Issue: | |
| Description: | Percentage of participants undergoing post-treatment interventions for the management of local symptoms by 3, 6, 9, and 12 months. |
| Measure: | Percentage of Participants Surviving at 12, 24, and 36 Months |
| Time Frame: | At 12, 24, and 36 months |
| Safety Issue: | |
| Description: | Percentage of participants surviving at 12, 24, and 36 months compared to all participants. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Janssen Research & Development, LLC |
Last Updated
February 1, 2021
