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

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ClinicalTrials.gov Identifier: NCT03404791
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Gemcitabine

Arm Intervention/treatment
Experimental: Radical Cystectomy Ineligible
TAR-200 is placed into the bladder through an Inserter and gradually releases gemcitabine during the 21-day indwelling period before being removed. Subjects will undergo an 84-day induction period comprised of four consecutive 21-day dosing cycles. Subjects may undergo up to 3 additional dosing cycles as maintenance.
Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per subject.




Primary Outcome Measures :
  1. 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 ]
    Will be assessed through the duration of the study by reported AEs

  2. 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 ]
    Will be assessed through the duration of the study by reported removals prior to the scheduled date of removal


Secondary Outcome Measures :
  1. Proportion of subjects with clinical complete response (cCR) [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)

  2. Proportion of subjects with clinical partial response (cPR) [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)

  3. Proportion of subjects with stable disease (SD) [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)

  4. Proportion of subjects with progression [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)

  5. Symptom control [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Defined as changes in bladder-related symptoms per the protocol-specified bladder symptom and toxicity grading system

  6. Time to intervention for symptom control [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Defined as the time from date of the first TAR-200 insertion to the date of intervention for symptom palliation

  7. Time to progression [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Defined as the time from the date of the first TAR-200 insertion to the date of first occurrence of progression

  8. Proportion of subjects undergoing post-treatment interventions by 3, 6, 9, and 12 months [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Number of subjects undergoing post-treatment interventions compared to all subjects

  9. Proportion of subjects surviving at 12 months [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Number of subject surviving at 12 months compared to all subjects



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404791


Contacts
Contact: TARIS Biomedical LLC +1-971-676-7750 clinops@tarisbio.com

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Clinical Trails Office - All Mayo Clinic Locations    855-776-0015      
United States, Georgia
North Georgia Urology Recruiting
Dalton, Georgia, United States, 30720
Contact: Tennille Emery    423-315-7240    tennille.emery@elligodirect.com   
United States, Maryland
Chesapeake Urology Enrolling by invitation
Hanover, Maryland, United States, 21076
United States, Michigan
Michigan Institute of Urology Recruiting
Troy, Michigan, United States, 48084
Contact: Danielle Osterhout, MLS(ASCP)CM    248-786-0467    OsterhoutD@michiganurology.com   
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Mare Perevich, BSN,CCRC    585-275-0989    mare_perevich@urmc.rochester.edu   
United States, Tennessee
Urology Associates of Nashville Recruiting
Nashville, Tennessee, United States, 37209
Contact: Rick Trotter, CRC    615-250-9268    crtrotter@ua-pc.com   
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Pam Steele, RN,BSN,CCRC    615-434-2120    pamela.steele@vanderbilt.edu   
United States, Texas
North Austin Urology Recruiting
Austin, Texas, United States, 78750
Contact: Atilano Mendoza    737-931-0927    atilano.mendoza@elligodirect.com   
United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Laurie Jackson    757-452-3461    LaurieJackson@urologyofva.net   
Sponsors and Collaborators
Taris Biomedical LLC
Investigators
Principal Investigator: Kirk A. Keegan, MD, MPH Vanderbilt University Medical Center

Responsible Party: Taris Biomedical LLC
ClinicalTrials.gov Identifier: NCT03404791     History of Changes
Other Study ID Numbers: TAR-200-103
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taris Biomedical LLC:
Bladder Cancer
Urothelial Carcinoma
Cystectomy
Radical Cystectomy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs