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

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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

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

Intervention:

  • Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03404791

Sponsor: Taris Biomedical LLC

Primary Outcome Measures:

  • 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
  • Time Frame: Study Day 0 to Study Day 84
  • Safety Issue:
  • 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
  • Time Frame: Study Day 0 to Study Day 84
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Proportion of subjects with clinical complete response (cCR)
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Proportion of subjects with clinical partial response (cPR)
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Proportion of subjects with stable disease (SD)
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Proportion of subjects with progression
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Symptom control
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Time to intervention for symptom control
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Time to progression
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Proportion of subjects undergoing post-treatment interventions by 3, 6, 9, and 12 months
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:
  • Measure: Proportion of subjects surviving at 12 months
  • Time Frame: Approximately Study Day 0 to Study Day 360
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: January 26, 2018

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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-2
  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
  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.

Contact:

  • TARIS Biomedical LLC
  • +1-971-676-7750

Locations:

  • Mayo Clinic
  • Phoenix Arizona 85054 United States
  • Chesapeake Urology
  • Hanover Maryland 21076 United States
  • Michigan Institute of Urology
  • Troy Michigan 48084 United States
  • University of Rochester Medical Center
  • Rochester New York 14642 United States
  • Urology Associates of Nashville
  • Nashville Tennessee 37209 United States
  • Vanderbilt University Medical Center
  • Nashville Tennessee 37232 United States
  • North Austin Urology
  • Austin Texas 78750 United States
  • Urology of Virginia
  • Virginia Beach Virginia 23462 United States
  • Fundacion Puigvert
  • Barcelona Spain
  • Hospital Universitario 12 de Octubre
  • Madrid Spain
  • Instituto Valenciano de Oncologia
  • Valencia Spain

View trial on ClinicalTrials.gov

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