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Brief Title: Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy

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

INTRODUCTION

  • Org Study ID: TAR-200-103
  • Secondary ID: N/A
  • NTC ID: NCT03404791
  • Sponsor: Taris Biomedical LLC

BRIEF SUMMARY


The purpose of this study is to determine if TAR-200, an investigational drug-delivery
system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are
unfit for radical cystectomy (RC) during an 84-day induction period comprised of four
consecutive 21-day dosing cycles.


  • Overall Status
    Recruiting
  • Start Date
    January 26, 2018
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with incidence of treatment emergent adverse events (TEAEs) over 4 consecutive 21-day dosing cycles of TAR-200 as assessed by CTCAE V4.0

Primary Outcome 1 - Timeframe: Study Day 0 to Study Day 84

Primary Outcome 2 - Measure: Number of participants that do not require TAR-200 removal prior to the scheduled date of removal due to meeting any of the Subject Stopping Safety Criteria or other drug or device related AE

Primary Outcome 2 - Timeframe: Study Day 0 to Study Day 84

CONDITION

  • Bladder Cancer TNM Staging Primary Tumor (T) T2A
  • Bladder Cancer TNM Staging Primary Tumor (T) T2B
  • Bladder Cancer TNM Staging Primary Tumor (T) T3A
  • Bladder Cancer TNM Staging Primary Tumor (T) T3B

ELIGIBILITY


Inclusion Criteria:

1. Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the
bladder.

2. Subject must have been as fully resected as possible per the physician's judgment.

3. Subjects must be deemed unfit for RC due to comorbid conditions with a risk of
mortality.

4. Subjects must refuse or be deemed ineligible for cisplatin-based chemotherapy.

5. Subject must refuse or not be eligible for radiotherapy.

6. Life expectancy of at least 4 months.

7. Adequate bone marrow, liver, and renal function.

8. Subjects must be willing to undergo a cystoscopy.

9. Subjects must be willing to undergo a biopsy for assessment of clinical response.

10. Written informed consent and authorization for release of personal health information
obtained according to local laws.

11. Age ≥18 years at the time of informed consent.

12. Females of childbearing potential must be willing to use an effective method of
contraception (hormonal or barrier method of birth control; abstinence) from the time
consent is signed until 4 weeks after treatment discontinuation. Subject's partner
must also use barrier protection while subject is on study until 4 weeks after
treatment discontinuation.

13. Males must be willing to use an effective method of contraception/method to avoid
seminal transfer (barrier method or abstinence) from the time consent is signed until
4 weeks after treatment discontinuation. Subject's partner must also use barrier
protection while subject is on study until 4 weeks after treatment discontinuation.

14. Females of childbearing potential must have a negative pregnancy test within 21 days
prior to Study Day 0.

Exclusion Criteria:

1. Other active malignancies.

2. 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.

3. Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy
tube is allowed).

4. Evidence of bladder perforation during diagnostic cystoscopy.

5. Bladder post-void residual volume (PVR) of >750 mL.

6. Concurrent clinically significant infections as determined by the treating
Investigator.

7. Known hypersensitivity to gemcitabine (or other drug excipients) or chemically related
drugs.

8. Known hypersensitivity to the device constituent or TARIS Inserter materials.

9. Use of an investigational product within 30 days or 5 half-lives, whichever is longer,
preceding Study Day 0.

10. Female subject who is lactating/breastfeeding.

11. Difficulty providing blood samples.

12. Unwilling or unable to provide informed consent or comply with the requirements of
this protocol, including the presence of any condition (physical, mental or social)
that is likely to affect the subject's return for scheduled visits and follow-up.

13. Other unspecified reasons that, in the opinion of the Investigator, make the subject
unsuitable for enrollment.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Kirk A. Keegan, MD, MPH

Role: Principal Investigator

Affiliation: Vanderbilt University Medical Center

Overall Contact

Name: Kirk A. Keegan, MD, MPH

Phone: +1-971-676-7750

Email: clinops@tarisbio.com

LOCATION

Facility Status Contact
Facility: Mayo Clinic
Phoenix, Arizona 85054
United States
Status: Recruiting Contact:
Clinical Trails Office - All Mayo Clinic Locations
855-776-0015
Facility: Chesapeake Urology
Hanover, Maryland 21076
United States
Status: Recruiting Contact:
Wendy Paxton, CCRC
443-471-5763
wpaxton@cua.md
Facility: Michigan Institute of Urology
Troy, Michigan 48084
United States
Status: Recruiting Contact:
Danielle Osterhout, MLS(ASCP)CM
248-786-0467
OsterhoutD@michiganurology.com
Facility: University of Rochester Medical Center
Rochester, New York 14642
United States
Status: Recruiting Contact:
Dee Doyle
585-275-0126
dee_doyle@urmc.rochester.edu
Facility: Urology Associates of Nashville
Nashville, Tennessee 37209
United States
Status: Recruiting Contact:
Rick Trotter, CRC
615-250-9268
crtrotter@ua-pc.com
Facility: Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Status: Recruiting Contact:
Pam Steele, RN,BSN,CCRC
615-434-2120
pamela.steele@vanderbilt.edu
Facility: North Austin Urology
Austin, Texas 78750
United States
Status: Recruiting Contact:
Atilano Mendoza
737-931-0927
atilano.mendoza@elligodirect.com
Facility: Urology of Virginia
Virginia Beach, Virginia 23462
United States
Status: Recruiting Contact:
Laurie Jackson
757-452-3461
LaurieJackson@urologyofva.net
Facility: Fundacion Puigvert
Barcelona,
Spain
Status: Recruiting Contact:
Vanesa Munoz
+34669894338
vmunoz@fundacio-puigvert.es
Facility: Hospital Universitario 12 de Octubre
Madrid,
Spain
Status: Recruiting Contact:
MaPaz Martin
+34659129581
curritina65@hotmail.com
Facility: Instituto Valenciano de Oncologia
Valencia,
Spain
Status: Recruiting Contact:
Vanesa Perez
+34961114003
vanesaivo@hotmail.es