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Completed

NCT Number: NCT03404791

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

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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Key information

Conditions

Urinary Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fund. Puigvert, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAR-200

Drug

TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.

Other names: Gemcitabine-Releasing Intravesical System (GemRIS)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Participants with Clinical Complete Response (cCR)

    Time frame: Up to Day 360

    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).

  2. Percentage of Participants with Clinical Partial Response (cPR)

    Time frame: Up to Day 360

    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).

  3. Percentage of Participants with Stable Disease (SD)

    Time frame: Up to Day 360

    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).

  4. Percentage of Participants with Disease Progression

    Time frame: Up to Day 360

    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)

  5. Symptom Control

    Time frame: Up to Day 360

    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).

  6. Time to Intervention for Symptom Control

    Time frame: Up to Day 360

    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.

  7. Time to Progression

    Time frame: Up to Day 360

    Time to progression, defined as the time from the date of the first TAR-200 insertion to the date of first occurrence of progression.

  8. 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 undergoing post-treatment interventions for the management of local symptoms by 3, 6, 9, and 12 months.

  9. Percentage of Participants Surviving at 12, 24, and 36 Months

    Time frame: At 12, 24, and 36 months

    Percentage of participants surviving at 12, 24, and 36 months compared to all participants.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Jan 19, 2018
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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