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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Urinary Bladder Neoplasms

Treatments: Drug: TAR-200

Study type: Interventional

Funder types: Industry

Identifiers

NCT03404791

TAR-200-103 (Other Identifier)

2017-003107-21 (EudraCT Number)

CR108889

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

Participants Ineligible for Radical Cystectomy

Experimental group

Description:

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.

Treatment:

Drug: TAR-200