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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | January 26, 2018 | Phase 1 | Interventional |
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 - Time Frame: 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 - Time Frame: Study Day 0 to Study Day 84
Criteria:
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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Kirk A. Keegan, MD, MPH
Role: Principal Investigator
Affiliation: Vanderbilt University Medical Center
Name: TARIS Biomedical LLC
Phone: +1-971-676-7750
Email: clinops@tarisbio.com
Facility | Status | Contact |
---|---|---|
Mayo Clinic Phoenix, Arizona 85054 United States |
Recruiting |
Clinical Trails Office - All Mayo Clinic Locations 855-776-0015 |
Chesapeake Urology Hanover, Maryland 21076 United States |
Recruiting |
Wendy Paxton, CCRC 443-471-5763 wpaxton@cua.md |
Michigan Institute of Urology Troy, Michigan 48084 United States |
Recruiting |
Danielle Osterhout, MLS(ASCP)CM 248-786-0467 OsterhoutD@michiganurology.com |
University of Rochester Medical Center Rochester, New York 14642 United States |
Recruiting |
Dee Doyle 585-275-0126 dee_doyle@urmc.rochester.edu |
Urology Associates of Nashville Nashville, Tennessee 37209 United States |
Recruiting |
Rick Trotter, CRC 615-250-9268 crtrotter@ua-pc.com |
Vanderbilt University Medical Center Nashville, Tennessee 37232 United States |
Recruiting |
Pam Steele, RN,BSN,CCRC 615-434-2120 pamela.steele@vanderbilt.edu |
North Austin Urology Austin, Texas 78750 United States |
Recruiting |
Atilano Mendoza 737-931-0927 atilano.mendoza@elligodirect.com |
Urology of Virginia Virginia Beach, Virginia 23462 United States |
Recruiting |
Laurie Jackson 757-452-3461 LaurieJackson@urologyofva.net |
Fundacion Puigvert Barcelona, Spain |
Recruiting |
Vanesa Munoz +34669894338 vmunoz@fundacio-puigvert.es |
Hospital Universitario 12 de Octubre Madrid, Spain |
Recruiting |
MaPaz Martin +34659129581 curritina65@hotmail.com |
Instituto Valenciano de Oncologia Valencia, Spain |
Recruiting |
Vanesa Perez +34961114003 vanesaivo@hotmail.es |