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

NCT03404791 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR108889TAR-200-1032017-003107-21
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 12

Brief 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.

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Percentage of Participants with Clinical Complete Response (cCR)

  Up to Day 360

• Percentage of Participants with Clinical Partial Response (cPR)

  Up to Day 360

• Percentage of Participants with Stable Disease (SD)

  Up to Day 360

• Percentage of Participants with Disease Progression

  Up to Day 360

• Symptom Control

  Up to Day 360

Study Arms (1)

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.

Drug: TAR-200

Interventions

TAR-200 DRUG

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)

Participants Ineligible for Radical Cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (12)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

North Georgia Urology Center

Dalton, Georgia, 30720, United States

Location

Chesapeake Urology Research Associates

Hanover, Maryland, 21076, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Urology Associates, PC

Nashville, Tennessee, 37209, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

North Austin Urology

Austin, Texas, 78750, United States

Location

Urology of Virginia, PLCC

Virginia Beach, Virginia, 23462, United States

Location

Fund. Puigvert

Barcelona, 08025, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Inst. Valenciano de Oncologia

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 19, 2018
• Study Start: November 20, 2017
• Primary Completion: December 23, 2019
• Study Completion: September 15, 2022
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (9); ES (3)